The Role of Nerve Blocks in Hip Arthroscopy
Primary Purpose
Femoroacetabular Impingement
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ropivacaine injection
Saline Solution for Injection
Sponsored by
About this trial
This is an interventional treatment trial for Femoroacetabular Impingement focused on measuring femoroacetabular impingement, hip arthroscopy, QL nerve block
Eligibility Criteria
Inclusion Criteria:
- Patients scheduled to receive unilateral arthroscopy hip surgery at Columbia University Medical Center with Dr. Lynch.
Exclusion Criteria:
- Patients scheduled to receive bilaterally or staged hip arthroscopy.
- Patients unwilling to participate in the research.
- History of chronic opioid use.
- Contraindication or allergy to study medications, such as QL block.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control
QL Block
Arm Description
Subjects will be randomized to receive a single-injection QL block with normal saline (Saline Solution for Injection).
Subjects will be randomized to receive a single-injection QL block with either local anesthetic (0.25% Ropivacaine injection).
Outcomes
Primary Outcome Measures
Pain Score
Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)
Pain Score
Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)
Pain Score
Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)
Pain Score
Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)
Pain Score
Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)
Pain Score
Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)
Pain Score
Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)
Pain Score
Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)
Pain Score
Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)
Pain Score
Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)
Oral Morphine Equivalents
Opioid consumption following surgery as self reported by patients, measured in mg
Oral Morphine Equivalents
Opioid consumption following surgery as self reported by patients, measured in mg
Oral Morphine Equivalents
Opioid consumption following surgery as self reported by patients, measured in mg
Patient Satisfaction Score
Patients will record their satisfaction following surgery on a scale of 0-10 (0 being not satisfied, 10 being fully satisfied)
Patient Satisfaction Score
Patients will record their satisfaction following surgery on a scale of 0-10 (0 being not satisfied, 10 being fully satisfied)
Patient Satisfaction Score
Patients will record their satisfaction following surgery on a scale of 0-10 (0 being not satisfied, 10 being fully satisfied)
Percentage of Patients Reporting Nausea and/or Vomiting
Patients will self report any instances of nausea and/or vomiting
Percentage of Patients Reporting Nausea and/or Vomiting
Patients will self report any instances of nausea and/or vomiting
Percentage of Patients Reporting Nausea and/or Vomiting
Patients will self report any instances of nausea and/or vomiting
Secondary Outcome Measures
HOS-ADL Questionnaire Score
Hip Outcome Survey (HOS) is a self-administered questionnaire with a scoring system composed of 2 sub-scales - a rating tool to assess a patient's level of ability. Activities of Daily Living (ADL) sub-scale made of 19 items. Scales are scored from 0 to 4, with 0 being 'unable to do' and 4, 'no difficulty'. The average of the total scores of the patients in each arm will be provided.
HOS-ADL Questionnaire Score
Hip Outcome Survey (HOS) is a self-administered questionnaire with a scoring system composed of 2 sub-scales - a rating tool to assess a patient's level of ability. Activities of Daily Living (ADL) sub-scale made of 19 items. Scales are scored from 0 to 4, with 0 being 'unable to do' and 4, 'no difficulty'. The average of the total scores of the patients in each arm will be provided.
mHHS Questionnaire Score
Modified Harris Hip Score (mHHS) is made up of 8 questions - a rating tool to assess how you are doing before and after surgery. The score is reported as 90-100 for excellent results, 80-89 being good, 70-79 fair, 60-69 poor, and below 60 a failed result.The average of the total scores of the patients in each arm will be provided.
mHHS Questionnaire Score
Modified Harris Hip Score (mHHS) is made up of 8 questions - a rating tool to assess how you are doing before and after surgery. The score is reported as 90-100 for excellent results, 80-89 being good, 70-79 fair, 60-69 poor, and below 60 a failed result.The average of the total scores of the patients in each arm will be provided.
HOOS - Symptoms and Stiffness Questionnaire Score
A 40 item questionnaire (hip disability and osteoarthritis outcome score, HOOS) to assess patient-relevant outcomes in five separate subscales. To answer each question, five Likert-boxes were used (no, mild, moderate, severe, extreme). All items were scored from zero to four, and each of the five subscales was calculated as the sum of the items included. The average of the total scores of the patients in each arm will be provided.
HOOS - Symptoms and Stiffness Questionnaire Score
A 40 item questionnaire (hip disability and osteoarthritis outcome score, HOOS) to assess patient-relevant outcomes in five separate subscales. To answer each question, five Likert-boxes were used (no, mild, moderate, severe, extreme). All items were scored from zero to four, and each of the five subscales was calculated as the sum of the items included. The average of the total scores of the patients in each arm will be provided.
HOOS - ADL Questionnaire Score
A 40 item questionnaire (hip disability and osteoarthritis outcome score, HOOS) to assess patient-relevant outcomes in five separate subscales. To answer each question, five Likert-boxes were used (no, mild, moderate, severe, extreme). All items were scored from zero to four, and each of the five subscales was calculated as the sum of the items included.This subscale: Activities of Daily Living. The average of the total scores of the patients in each arm will be provided.
HOOS - ADL Questionnaire Score
A 40 item questionnaire (hip disability and osteoarthritis outcome score, HOOS) to assess patient-relevant outcomes in five separate subscales. To answer each question, five Likert-boxes were used (no, mild, moderate, severe, extreme). All items were scored from zero to four, and each of the five subscales was calculated as the sum of the items included.This subscale: Activities of Daily Living. The average of the total scores of the patients in each arm will be provided.
HOOS - Sports Questionnaire Score
HOOS will be used to assess patient-relevant outcomes in five separate subscales. To answer each question, five Likert-boxes were used (no, mild, moderate, severe, extreme). All items were scored from zero to four, and each of the five subscales was calculated as the sum of the items included. This subscale: Sport and Recreation Function (SP) (four items). The average of the total scores of the patients in each arm will be provided.
HOOS - Sports Questionnaire Score
HOOS will be used to assess patient-relevant outcomes in five separate subscales. To answer each question, five Likert-boxes were used (no, mild, moderate, severe, extreme). All items were scored from zero to four, and each of the five subscales was calculated as the sum of the items included. This subscale: Sport and Recreation Function (SP) (four items). The average of the total scores of the patients in each arm will be provided.
HOOS - Quality of Life Questionnaire Score
HOOS will be used to assess patient-relevant outcomes in five separate subscales. To answer each question, five Likert-boxes were used (no, mild, moderate, severe, extreme). All items were scored from zero to four, and each of the five subscales was calculated as the sum of the items included. This subscale: Hip Related Quality of Life (Q) (four items). The average of the total scores of the patients in each arm will be provided.
HOOS - Quality of Life Questionnaire Score
HOOS will be used to assess patient-relevant outcomes in five separate subscales. To answer each question, five Likert-boxes were used (no, mild, moderate, severe, extreme). All items were scored from zero to four, and each of the five subscales was calculated as the sum of the items included. This subscale: Hip Related Quality of Life (Q) (four items). The average of the total scores of the patients in each arm will be provided.
UCLA Activity Score Questionnaire Score
University of California, Los Angeles (UCLA) activity scale is a simple scale ranging from 1 to 10. The patient indicates her or his most appropriate activity level, with 1 defined as "no physical activity, dependent on others" and 10 defined as "regular participation in impact sports." The average of the total scores of the patients in each arm will be provided.
UCLA Activity Score Questionnaire Score
University of California, Los Angeles (UCLA) activity scale is a simple scale ranging from 1 to 10. The patient indicates her or his most appropriate activity level, with 1 defined as "no physical activity, dependent on others" and 10 defined as "regular participation in impact sports." The average of the total scores of the patients in each arm will be provided.
VR-12 Mental Health Questionnaire Score
Veterans Rand 12 Item Health Survey (VR-12) is a brief, generic, multi-use, self-administered health survey comprised of 12 items. The instrument is primarily used to measure health-related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items are summarized into two scores, one for mental health and one for physical health. The average of the total scores of the patients in each arm will be provided.
VR-12 Mental Health Questionnaire Score
Veterans Rand 12 Item Health Survey (VR-12) is a brief, generic, multi-use, self-administered health survey comprised of 12 items. The instrument is primarily used to measure health-related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items are summarized into two scores, one for mental health and one for physical health. The average of the total scores of the patients in each arm will be provided.
VR-12 Physical Health Questionnaire Score
VR-12 will be used to measure health-related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items are summarized into two scores, one for mental health and one for physical health.The average of the total scores of the patients in each arm will be provided.
VR-12 Physical Health Questionnaire Score
VR-12 will be used to measure health-related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items are summarized into two scores, one for mental health and one for physical health.The average of the total scores of the patients in each arm will be provided.
HOOS - Short Form Total Score Questionnaire Score
HOOS will be used to assess patient-relevant outcomes in five separate subscales. To answer each question, five Likert-boxes were used (no, mild, moderate, severe, extreme). All items were scored from zero to four, and each of the five subscales was calculated as the sum of the items included. The average of the total scores of the patients in each arm will be provided.
HOOS - Short Form Total Score Questionnaire Score
HOOS will be used to assess patient-relevant outcomes in five separate subscales. To answer each question, five Likert-boxes were used (no, mild, moderate, severe, extreme). All items were scored from zero to four, and each of the five subscales was calculated as the sum of the items included. The average of the total scores of the patients in each arm will be provided.
iHOT-12 Questionnaire Score
A Short Version of the International Hip Outcome Tool (iHOT-12) self administered outcome measure based on a Visual Analogue Scale response format designed for young and active population with hip pathology. The average of the total scores of the patients in each arm will be provided.
iHOT-12 Questionnaire Score
A Short Version of the International Hip Outcome Tool (iHOT-12) self administered outcome measure based on a Visual Analogue Scale response format designed for young and active population with hip pathology. The average of the total scores of the patients in each arm will be provided.
PROMIS v1.1 Pain Interference Questionnaire Score
PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health. The Pain Interference Questionnaire is comprised of 56 items, total score will be calculated. PROMIS is a computer adaptive test with branching logic. To answer each question, five Likert-boxes were used. The average of the total scores of the patients in each arm will be provided.
PROMIS v1.1 Pain Interference Questionnaire Score
PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health. The Pain Interference Questionnaire is comprised of 56 items, total score will be calculated. PROMIS is a computer adaptive test with branching logic. To answer each question, five Likert-boxes were used. The average of the total scores of the patients in each arm will be provided.
PROMIS v1.0 Pain Intensity 3a Questionnaire Score
PROMIS is a computer adaptive test with branching logic. The Pain Intensity Questionnaire is comprised of 3 items, total score will be calculated. To answer each question, five Likert-boxes were used (no pain, mild, moderate, severe, very severe). The average of the total scores of the patients in each arm will be provided.
PROMIS v1.0 Pain Intensity 3a Questionnaire Score
PROMIS is a computer adaptive test with branching logic. The Pain Intensity Questionnaire is comprised of 3 items, total score will be calculated. To answer each question, five Likert-boxes were used (no pain, mild, moderate, severe, very severe). The average of the total scores of the patients in each arm will be provided.
PROMIS v1.2 Physical Function Questionnaire Score
PROMIS is a computer adaptive test with branching logic. The Physical Function Questionnaire is comprised of 170 items, total score will be calculated. To answer each question, five Likert-boxes were used (without any difficulty, with a little difficulty, with some difficulty, with much difficulty, unable to do). The average of the total scores of the patients in each arm will be provided.
PROMIS v1.2 Physical Function Questionnaire Score
PROMIS is a computer adaptive test with branching logic. The Physical Function Questionnaire is comprised of 170 items, total score will be calculated. To answer each question, five Likert-boxes were used (without any difficulty, with a little difficulty, with some difficulty, with much difficulty, unable to do). The average of the total scores of the patients in each arm will be provided.
PROMIS v2.0 Ability to Participate Socially Questionnaire Score
PROMIS is a computer adaptive test with branching logic. The Ability to Participate Socially Questionnaire is comprised of 35 items, total score will be calculated. To answer each question, five Likert-boxes were used (never, rarely, sometimes, usually, always). The average of the total scores of the patients in each arm will be provided.
PROMIS v2.0 Ability to Participate Socially Questionnaire Score
PROMIS is a computer adaptive test with branching logic. The Ability to Participate Socially Questionnaire is comprised of 35 items, total score will be calculated. To answer each question, five Likert-boxes were used (never, rarely, sometimes, usually, always). The average of the total scores of the patients in each arm will be provided.
PROMIS v2.0 Satisfaction with Roles and Activities Questionnaire Score
PROMIS is a computer adaptive test with branching logic. The Ability to Participate Socially Questionnaire is comprised of 44 items, total score will be calculated. To answer each question, five Likert-boxes were used (not at all, a little bit, somewhat, quite a bit, very much). The average of the total scores of the patients in each arm will be provided.
PROMIS v2.0 Satisfaction with Roles and Activities Questionnaire Score
PROMIS is a computer adaptive test with branching logic. The Ability to Participate Socially Questionnaire is comprised of 44 items, total score will be calculated. To answer each question, five Likert-boxes were used (not at all, a little bit, somewhat, quite a bit, very much). The average of the total scores of the patients in each arm will be provided.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03506620
Brief Title
The Role of Nerve Blocks in Hip Arthroscopy
Official Title
The Role of Nerve Blocks in Hip Arthroscopy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Unforeseen cost restrictions of the drug halted the execution of this study altogether.
Study Start Date
January 2019 (Anticipated)
Primary Completion Date
February 7, 2020 (Actual)
Study Completion Date
February 7, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this study is to determine whether QL blocks reduce opioid consumption following arthroscopic hip surgery by decreasing postoperative pain. Considering the current opioid epidemic, the responsibility of physicians to help prevent addiction, and the increasing prevalence of arthroscopic hip surgeries, this study holds a tremendous potential benefit for future patients.
Detailed Description
The popularity of arthroscopic hip surgery has increased greatly over the last 10 years, particularly for correcting Femoroacetabular Impingement (FAI). FAI is a structural abnormality of the proximal femur, the acetabulum, or both. It is a leading cause of labral tears in the hip joint and can cause cartilage damage, which may increase subsequent risk of developing osteoarthritis. Though far less invasive than open hip surgery such as for a total hip replacement, hip arthroscopy can cause significant postoperative pain for the patient. Given how relatively new the procedure still is, methods of pain control are highly variable. Peripheral nerve blocks, mainly femoral nerve and lumbar plexus blocks, have been used by some surgeons to control postoperative pain. However, in addition to their sensory effects, these blocks cause motor impairment that has been associated with a significantly higher risk of falling.
In managing pain after any operation, opioid consumption is, of course, a significant concern. Ideally, hip arthroscopy patients could receive a peripheral nerve block that decreases pain and the need for opioids, but without the muscular weakness and increased fall risk observed with femoral nerve and lumbar plexus blocks. This may be achievable with the newer Quadratus Lumborum (QL) block.
The ultrasound-guided QL block is currently most commonly used for abdominal surgery.
However, several case studies of a single-injection QL block in hip replacement surgeries have been successful in minimizing pain and opioid use while sparing motor function and avoiding the muscle weakness that can lead to falls. In the approach utilized in these cases, local anesthetic was injected at the anterolateral border of the QL muscle to achieve analgesia ranging from the T6-T10 through L3 dermatomes. One group has anecdotally reported great success in using these QL blocks for alleviating postoperative pain with hip arthroscopy, but no studies to date have evaluated the effectiveness of QL blocks for arthroscopic hip surgery.
This study is a randomized, controlled, double-blind trial. Patients undergoing hip arthroscopy who agree to participate will be randomly selected to receive an ultrasound-guided QL block with either local anesthetic (QL block group) or normal saline (control group) preoperatively.
After surgery and during the first postoperative week, patients will record their numerical pain score, the location of their pain, and their opioid consumption using our attached study instrument. On this form, they will record their pain score at 0.5, 1, 1.5, 2, 4, 6, 12, 24, and 48 hours and 7 days after surgery. The form specifies that if patients are unable to record their pain score at any of these time points, particularly because they are sleeping/recovering, they can simply skip that time point. For pain location, patients are instructed to draw X's on a standard cartoon at the site of their pain. For opioid consumption, patients simply record when and how many pills they take. This form will be collected from patients at their 10-14 day postoperative visit. Data will also be collected from the medical chart on time to discharge and any complications in the perioperative period. Questionnaires will be used to assess pain, physical and social health, such as Patient-Reported Outcomes Measurement Information System (PROMIS).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoroacetabular Impingement
Keywords
femoroacetabular impingement, hip arthroscopy, QL nerve block
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
This study is a randomized, controlled, double-blind trial. Patients undergoing hip arthroscopy who agree to participate will be randomly selected to receive an ultrasound-guided QL block with either local anesthetic (QL block group) or normal saline (control group) preoperatively.
Masking
ParticipantCare Provider
Masking Description
The anesthesiologist, surgeon, and patient will all be blinded to the intervention. After patients consent to join the study, a member of the study team who is not involved in patient care will randomly allocate patients to 1 of 2 groups, the intervention or the controls. A statistician not involved with the study will creat a randomization table and coordinate with the Research Pharmacy to keep the study team blinded. Naropin (Ropivacaine) will be dispensed by the research pharmacy. The nurse will prepare the study injection accordingly for the blind anesthesiologist to administer. The QL block will be administered by a trained musculoskeletal regional anesthesia specialist before the standard induction of general anesthesia. The injection will occur under sedation to minimize discomfort for the patient. The QL block group's injection will consist of 20 cc of 0.25% Ropivacaine, whereas the control group will receive 20 cc of saline.
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Subjects will be randomized to receive a single-injection QL block with normal saline (Saline Solution for Injection).
Arm Title
QL Block
Arm Type
Experimental
Arm Description
Subjects will be randomized to receive a single-injection QL block with either local anesthetic (0.25% Ropivacaine injection).
Intervention Type
Drug
Intervention Name(s)
Ropivacaine injection
Other Intervention Name(s)
Naropin
Intervention Description
Naropin (Ropivacaine HCl) 0.25%; Dose: 20 cc
Intervention Type
Drug
Intervention Name(s)
Saline Solution for Injection
Other Intervention Name(s)
Normal Saline
Intervention Description
20 cc of saline will be injected in the form of a QL block as a placebo.
Primary Outcome Measure Information:
Title
Pain Score
Description
Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)
Time Frame
0.5 hour
Title
Pain Score
Description
Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)
Time Frame
1 hour
Title
Pain Score
Description
Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)
Time Frame
1.5 hours
Title
Pain Score
Description
Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)
Time Frame
2 hours
Title
Pain Score
Description
Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)
Time Frame
4 hours
Title
Pain Score
Description
Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)
Time Frame
6 hours
Title
Pain Score
Description
Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)
Time Frame
12 hours
Title
Pain Score
Description
Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)
Time Frame
24 hours
Title
Pain Score
Description
Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)
Time Frame
48 hours
Title
Pain Score
Description
Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)
Time Frame
7 days
Title
Oral Morphine Equivalents
Description
Opioid consumption following surgery as self reported by patients, measured in mg
Time Frame
24 hours after surgery
Title
Oral Morphine Equivalents
Description
Opioid consumption following surgery as self reported by patients, measured in mg
Time Frame
48 hours after surgery
Title
Oral Morphine Equivalents
Description
Opioid consumption following surgery as self reported by patients, measured in mg
Time Frame
7 days after surgery
Title
Patient Satisfaction Score
Description
Patients will record their satisfaction following surgery on a scale of 0-10 (0 being not satisfied, 10 being fully satisfied)
Time Frame
24 hours after surgery
Title
Patient Satisfaction Score
Description
Patients will record their satisfaction following surgery on a scale of 0-10 (0 being not satisfied, 10 being fully satisfied)
Time Frame
48 hours after surgery
Title
Patient Satisfaction Score
Description
Patients will record their satisfaction following surgery on a scale of 0-10 (0 being not satisfied, 10 being fully satisfied)
Time Frame
7 days after surgery
Title
Percentage of Patients Reporting Nausea and/or Vomiting
Description
Patients will self report any instances of nausea and/or vomiting
Time Frame
24 hours after surgery
Title
Percentage of Patients Reporting Nausea and/or Vomiting
Description
Patients will self report any instances of nausea and/or vomiting
Time Frame
48 hours after surgery
Title
Percentage of Patients Reporting Nausea and/or Vomiting
Description
Patients will self report any instances of nausea and/or vomiting
Time Frame
7 days after surgery
Secondary Outcome Measure Information:
Title
HOS-ADL Questionnaire Score
Description
Hip Outcome Survey (HOS) is a self-administered questionnaire with a scoring system composed of 2 sub-scales - a rating tool to assess a patient's level of ability. Activities of Daily Living (ADL) sub-scale made of 19 items. Scales are scored from 0 to 4, with 0 being 'unable to do' and 4, 'no difficulty'. The average of the total scores of the patients in each arm will be provided.
Time Frame
Baseline preoperative
Title
HOS-ADL Questionnaire Score
Description
Hip Outcome Survey (HOS) is a self-administered questionnaire with a scoring system composed of 2 sub-scales - a rating tool to assess a patient's level of ability. Activities of Daily Living (ADL) sub-scale made of 19 items. Scales are scored from 0 to 4, with 0 being 'unable to do' and 4, 'no difficulty'. The average of the total scores of the patients in each arm will be provided.
Time Frame
2 weeks after surgery
Title
mHHS Questionnaire Score
Description
Modified Harris Hip Score (mHHS) is made up of 8 questions - a rating tool to assess how you are doing before and after surgery. The score is reported as 90-100 for excellent results, 80-89 being good, 70-79 fair, 60-69 poor, and below 60 a failed result.The average of the total scores of the patients in each arm will be provided.
Time Frame
Baseline preoperative
Title
mHHS Questionnaire Score
Description
Modified Harris Hip Score (mHHS) is made up of 8 questions - a rating tool to assess how you are doing before and after surgery. The score is reported as 90-100 for excellent results, 80-89 being good, 70-79 fair, 60-69 poor, and below 60 a failed result.The average of the total scores of the patients in each arm will be provided.
Time Frame
2 weeks after surgery
Title
HOOS - Symptoms and Stiffness Questionnaire Score
Description
A 40 item questionnaire (hip disability and osteoarthritis outcome score, HOOS) to assess patient-relevant outcomes in five separate subscales. To answer each question, five Likert-boxes were used (no, mild, moderate, severe, extreme). All items were scored from zero to four, and each of the five subscales was calculated as the sum of the items included. The average of the total scores of the patients in each arm will be provided.
Time Frame
Baseline preoperatively
Title
HOOS - Symptoms and Stiffness Questionnaire Score
Description
A 40 item questionnaire (hip disability and osteoarthritis outcome score, HOOS) to assess patient-relevant outcomes in five separate subscales. To answer each question, five Likert-boxes were used (no, mild, moderate, severe, extreme). All items were scored from zero to four, and each of the five subscales was calculated as the sum of the items included. The average of the total scores of the patients in each arm will be provided.
Time Frame
2 weeks after surgery
Title
HOOS - ADL Questionnaire Score
Description
A 40 item questionnaire (hip disability and osteoarthritis outcome score, HOOS) to assess patient-relevant outcomes in five separate subscales. To answer each question, five Likert-boxes were used (no, mild, moderate, severe, extreme). All items were scored from zero to four, and each of the five subscales was calculated as the sum of the items included.This subscale: Activities of Daily Living. The average of the total scores of the patients in each arm will be provided.
Time Frame
Baseline preoperatively
Title
HOOS - ADL Questionnaire Score
Description
A 40 item questionnaire (hip disability and osteoarthritis outcome score, HOOS) to assess patient-relevant outcomes in five separate subscales. To answer each question, five Likert-boxes were used (no, mild, moderate, severe, extreme). All items were scored from zero to four, and each of the five subscales was calculated as the sum of the items included.This subscale: Activities of Daily Living. The average of the total scores of the patients in each arm will be provided.
Time Frame
2 weeks after surgery
Title
HOOS - Sports Questionnaire Score
Description
HOOS will be used to assess patient-relevant outcomes in five separate subscales. To answer each question, five Likert-boxes were used (no, mild, moderate, severe, extreme). All items were scored from zero to four, and each of the five subscales was calculated as the sum of the items included. This subscale: Sport and Recreation Function (SP) (four items). The average of the total scores of the patients in each arm will be provided.
Time Frame
Baseline preoperatively
Title
HOOS - Sports Questionnaire Score
Description
HOOS will be used to assess patient-relevant outcomes in five separate subscales. To answer each question, five Likert-boxes were used (no, mild, moderate, severe, extreme). All items were scored from zero to four, and each of the five subscales was calculated as the sum of the items included. This subscale: Sport and Recreation Function (SP) (four items). The average of the total scores of the patients in each arm will be provided.
Time Frame
2 weeks after surgery
Title
HOOS - Quality of Life Questionnaire Score
Description
HOOS will be used to assess patient-relevant outcomes in five separate subscales. To answer each question, five Likert-boxes were used (no, mild, moderate, severe, extreme). All items were scored from zero to four, and each of the five subscales was calculated as the sum of the items included. This subscale: Hip Related Quality of Life (Q) (four items). The average of the total scores of the patients in each arm will be provided.
Time Frame
Baseline preoperatively
Title
HOOS - Quality of Life Questionnaire Score
Description
HOOS will be used to assess patient-relevant outcomes in five separate subscales. To answer each question, five Likert-boxes were used (no, mild, moderate, severe, extreme). All items were scored from zero to four, and each of the five subscales was calculated as the sum of the items included. This subscale: Hip Related Quality of Life (Q) (four items). The average of the total scores of the patients in each arm will be provided.
Time Frame
2 weeks after surgery
Title
UCLA Activity Score Questionnaire Score
Description
University of California, Los Angeles (UCLA) activity scale is a simple scale ranging from 1 to 10. The patient indicates her or his most appropriate activity level, with 1 defined as "no physical activity, dependent on others" and 10 defined as "regular participation in impact sports." The average of the total scores of the patients in each arm will be provided.
Time Frame
Baseline preoperatively
Title
UCLA Activity Score Questionnaire Score
Description
University of California, Los Angeles (UCLA) activity scale is a simple scale ranging from 1 to 10. The patient indicates her or his most appropriate activity level, with 1 defined as "no physical activity, dependent on others" and 10 defined as "regular participation in impact sports." The average of the total scores of the patients in each arm will be provided.
Time Frame
2 weeks after surgery
Title
VR-12 Mental Health Questionnaire Score
Description
Veterans Rand 12 Item Health Survey (VR-12) is a brief, generic, multi-use, self-administered health survey comprised of 12 items. The instrument is primarily used to measure health-related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items are summarized into two scores, one for mental health and one for physical health. The average of the total scores of the patients in each arm will be provided.
Time Frame
Baseline preoperatively
Title
VR-12 Mental Health Questionnaire Score
Description
Veterans Rand 12 Item Health Survey (VR-12) is a brief, generic, multi-use, self-administered health survey comprised of 12 items. The instrument is primarily used to measure health-related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items are summarized into two scores, one for mental health and one for physical health. The average of the total scores of the patients in each arm will be provided.
Time Frame
2 weeks after surgery
Title
VR-12 Physical Health Questionnaire Score
Description
VR-12 will be used to measure health-related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items are summarized into two scores, one for mental health and one for physical health.The average of the total scores of the patients in each arm will be provided.
Time Frame
Baseline preoperatively
Title
VR-12 Physical Health Questionnaire Score
Description
VR-12 will be used to measure health-related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items are summarized into two scores, one for mental health and one for physical health.The average of the total scores of the patients in each arm will be provided.
Time Frame
2 weeks after surgery
Title
HOOS - Short Form Total Score Questionnaire Score
Description
HOOS will be used to assess patient-relevant outcomes in five separate subscales. To answer each question, five Likert-boxes were used (no, mild, moderate, severe, extreme). All items were scored from zero to four, and each of the five subscales was calculated as the sum of the items included. The average of the total scores of the patients in each arm will be provided.
Time Frame
Baseline preoperatively
Title
HOOS - Short Form Total Score Questionnaire Score
Description
HOOS will be used to assess patient-relevant outcomes in five separate subscales. To answer each question, five Likert-boxes were used (no, mild, moderate, severe, extreme). All items were scored from zero to four, and each of the five subscales was calculated as the sum of the items included. The average of the total scores of the patients in each arm will be provided.
Time Frame
2 weeks after surgery
Title
iHOT-12 Questionnaire Score
Description
A Short Version of the International Hip Outcome Tool (iHOT-12) self administered outcome measure based on a Visual Analogue Scale response format designed for young and active population with hip pathology. The average of the total scores of the patients in each arm will be provided.
Time Frame
Baseline preoperatively
Title
iHOT-12 Questionnaire Score
Description
A Short Version of the International Hip Outcome Tool (iHOT-12) self administered outcome measure based on a Visual Analogue Scale response format designed for young and active population with hip pathology. The average of the total scores of the patients in each arm will be provided.
Time Frame
2 weeks after surgery
Title
PROMIS v1.1 Pain Interference Questionnaire Score
Description
PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health. The Pain Interference Questionnaire is comprised of 56 items, total score will be calculated. PROMIS is a computer adaptive test with branching logic. To answer each question, five Likert-boxes were used. The average of the total scores of the patients in each arm will be provided.
Time Frame
Baseline preoperatively
Title
PROMIS v1.1 Pain Interference Questionnaire Score
Description
PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health. The Pain Interference Questionnaire is comprised of 56 items, total score will be calculated. PROMIS is a computer adaptive test with branching logic. To answer each question, five Likert-boxes were used. The average of the total scores of the patients in each arm will be provided.
Time Frame
2 weeks after surgery
Title
PROMIS v1.0 Pain Intensity 3a Questionnaire Score
Description
PROMIS is a computer adaptive test with branching logic. The Pain Intensity Questionnaire is comprised of 3 items, total score will be calculated. To answer each question, five Likert-boxes were used (no pain, mild, moderate, severe, very severe). The average of the total scores of the patients in each arm will be provided.
Time Frame
Baseline preoperatively
Title
PROMIS v1.0 Pain Intensity 3a Questionnaire Score
Description
PROMIS is a computer adaptive test with branching logic. The Pain Intensity Questionnaire is comprised of 3 items, total score will be calculated. To answer each question, five Likert-boxes were used (no pain, mild, moderate, severe, very severe). The average of the total scores of the patients in each arm will be provided.
Time Frame
2 weeks after surgery
Title
PROMIS v1.2 Physical Function Questionnaire Score
Description
PROMIS is a computer adaptive test with branching logic. The Physical Function Questionnaire is comprised of 170 items, total score will be calculated. To answer each question, five Likert-boxes were used (without any difficulty, with a little difficulty, with some difficulty, with much difficulty, unable to do). The average of the total scores of the patients in each arm will be provided.
Time Frame
Baseline preoperatively
Title
PROMIS v1.2 Physical Function Questionnaire Score
Description
PROMIS is a computer adaptive test with branching logic. The Physical Function Questionnaire is comprised of 170 items, total score will be calculated. To answer each question, five Likert-boxes were used (without any difficulty, with a little difficulty, with some difficulty, with much difficulty, unable to do). The average of the total scores of the patients in each arm will be provided.
Time Frame
2 weeks after surgery
Title
PROMIS v2.0 Ability to Participate Socially Questionnaire Score
Description
PROMIS is a computer adaptive test with branching logic. The Ability to Participate Socially Questionnaire is comprised of 35 items, total score will be calculated. To answer each question, five Likert-boxes were used (never, rarely, sometimes, usually, always). The average of the total scores of the patients in each arm will be provided.
Time Frame
Baseline preoperatively
Title
PROMIS v2.0 Ability to Participate Socially Questionnaire Score
Description
PROMIS is a computer adaptive test with branching logic. The Ability to Participate Socially Questionnaire is comprised of 35 items, total score will be calculated. To answer each question, five Likert-boxes were used (never, rarely, sometimes, usually, always). The average of the total scores of the patients in each arm will be provided.
Time Frame
2 weeks after surgery
Title
PROMIS v2.0 Satisfaction with Roles and Activities Questionnaire Score
Description
PROMIS is a computer adaptive test with branching logic. The Ability to Participate Socially Questionnaire is comprised of 44 items, total score will be calculated. To answer each question, five Likert-boxes were used (not at all, a little bit, somewhat, quite a bit, very much). The average of the total scores of the patients in each arm will be provided.
Time Frame
Baseline preoperatively
Title
PROMIS v2.0 Satisfaction with Roles and Activities Questionnaire Score
Description
PROMIS is a computer adaptive test with branching logic. The Ability to Participate Socially Questionnaire is comprised of 44 items, total score will be calculated. To answer each question, five Likert-boxes were used (not at all, a little bit, somewhat, quite a bit, very much). The average of the total scores of the patients in each arm will be provided.
Time Frame
2 weeks after surgery
Other Pre-specified Outcome Measures:
Title
Time to Discharge
Description
The average time for the experimental patients to be discharged (in minutes)
Time Frame
Up to 1 day (day of surgery)
Title
Percentage of patients reporting falls in the first 24 hours after surgery
Description
Falls will be self reported by patients
Time Frame
24 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients scheduled to receive unilateral arthroscopy hip surgery at Columbia University Medical Center with Dr. Lynch.
Exclusion Criteria:
Patients scheduled to receive bilaterally or staged hip arthroscopy.
Patients unwilling to participate in the research.
History of chronic opioid use.
Contraindication or allergy to study medications, such as QL block.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas S Lynch, M.D.
Organizational Affiliation
Columbia University Department of Orthopedics
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28036319
Citation
La Colla L, Ben-David B, Merman R. Quadratus Lumborum Block as an Alternative to Lumbar Plexus Block for Hip Surgery: A Report of 2 Cases. A A Case Rep. 2017 Jan 1;8(1):4-6. doi: 10.1213/XAA.0000000000000406.
Results Reference
background
PubMed Identifier
27997495
Citation
La Colla L, Uskova A, Ben-David B. Single-shot Quadratus Lumborum Block for Postoperative Analgesia After Minimally Invasive Hip Arthroplasty: A New Alternative to Continuous Lumbar Plexus Block? Reg Anesth Pain Med. 2017 Jan/Feb;42(1):125-126. doi: 10.1097/AAP.0000000000000523. No abstract available.
Results Reference
background
PubMed Identifier
28609336
Citation
Ben-David B, La Colla L. Extravasated Fluid in Hip Arthroscopy and Pain: Is Quadratus Lumborum Block the Answer? Anesth Analg. 2017 Jul;125(1):364. doi: 10.1213/ANE.0000000000002198. No abstract available.
Results Reference
background
Learn more about this trial
The Role of Nerve Blocks in Hip Arthroscopy
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