Back to resultsLumbar Plexus Block for Postoperative Pain Control After Hip Arthroscopy. A Randomized Controlled Trial (LPB Hip Scope)
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lumbar Plexus Blockade
Control
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) Class 1-3
- Patients aged 18 to 65 years
- Patients scheduled for primary, unilateral arthroscopic hip surgery by Dr. Kelly, Dr. Coleman, or Dr. Anil Ranawat
- Planned use of neuraxial anesthesia
- Body Mass Index less than 35
- Ability to follow study protocol
Exclusion Criteria:
- Chronic opioid use (defined as daily or almost daily use of opioids for >3 months)
- Contraindication to combined spinal-epidural anesthesia including but not limited to bleeding disorder, use of clinically relevant anticoagulant or antiplatelet medications, and anatomic abnormalities.
- Contraindication to lumbar plexus block including but not limited to bleeding disorder, use of clinically relevant anticoagulant or antiplatelet medications, and anatomic abnormalities.
- Infection at the injection site(s)
- Allergy to any of the study medications
- Contraindication to a short course of NSAIDs (renal failure, intolerance)
- ASA Class 4-5
- Patient refusal
- Patients younger than 18 years old and older than 65
- Patients with any known indwelling hardware of the lumbar spine.
- Patients with a peripheral neuropathy of the surgical extremity
- Non-English speaking patients
Sites / Locations
- Hospital for Special Surgery
- New York Presbyterian Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Lumbar Plexus Blockade + CSE
Control Group
Arm Description
The study group will receive a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
The control group will receive only a combined spinal-epidural.
Outcomes
Primary Outcome Measures
Numeric Rating Scale (NRS) Pain at Rest (0-10) on Day of Surgery Prior to Discharge
The Numeric Rating Scale was used to ask patients to rate their pain at rest on a scale of 0 to 10, 0 = no pain and 10 = worst pain imaginable.
Secondary Outcome Measures
Readiness to Discharge From Post-Anesthesia Care Unit (PACU)
Time to readiness for discharge from the PACU. Patients were considered ready for PACU discharge when they met the following criteria: a) Awake, alert, oriented and responsive b) Minimal pain, Numeric Rating Scale < 5/10 (0 = no pain, 10 = worst imaginable pain) (parenteral [injected] medications not required) c) Vital signs stable d) No active bleeding e) Minimal or no nausea f) Not vomiting, tolerating oral intake g) Oxygen saturation > 94% (or baseline) on room air h) Patient has urinated.
Narcotic Pain Medication Needed
Incidence of Nausea
The number of participants with nausea.
Incidence of Vomiting
The number of participants who vomited.
Requirement of Antiemetic Rescue
The number of participants who needed medication to treat their nausea and vomiting.
Patient Satisfaction
Patient Satisfaction (0-10; 0 = very dissatisfied, 10 = very satisfied)
Quality of Recovery (QoR-40) Physical Comfort Dimension
Assessment of Physical Comfort (minimum score = 12, maximum score = 60). Higher values represent a better outcome
Full Information
NCT ID
NCT01286805
First Posted
January 28, 2011
Last Updated
May 1, 2013
Sponsor
Hospital for Special Surgery, New York
Collaborators
New York Presbyterian Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01286805
Brief Title
Lumbar Plexus Block for Postoperative Pain Control After Hip Arthroscopy. A Randomized Controlled Trial
Acronym
LPB Hip Scope
Official Title
Lumbar Plexus Block for Postoperative Pain Control After Hip Arthroscopy. A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York
Collaborators
New York Presbyterian Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether the use of a lumbar plexus block for arthroscopic hip surgery is superior to oral and intravenous opioid pain medications alone in treating pain. In addition, the study will examine whether lumbar plexus blocks reduce the total amount of pain medication needed, and therefore reduce the side effects of these medicines and increase patient satisfaction. It is hypothesized that addition of the lumbar plexus block will significantly reduce patients' postoperative pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
83 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lumbar Plexus Blockade + CSE
Arm Type
Experimental
Arm Description
The study group will receive a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
The control group will receive only a combined spinal-epidural.
Intervention Type
Procedure
Intervention Name(s)
Lumbar Plexus Blockade
Other Intervention Name(s)
Marcaine
Intervention Description
The lumbar plexus block will be dosed with 30 milliliters of 0.25% bupivacaine with 1:200,000 epinephrine
Intervention Type
Procedure
Intervention Name(s)
Control
Intervention Description
The control group will receive only a combined spinal-epidural.
Primary Outcome Measure Information:
Title
Numeric Rating Scale (NRS) Pain at Rest (0-10) on Day of Surgery Prior to Discharge
Description
The Numeric Rating Scale was used to ask patients to rate their pain at rest on a scale of 0 to 10, 0 = no pain and 10 = worst pain imaginable.
Time Frame
Day of surgery prior to discharge
Secondary Outcome Measure Information:
Title
Readiness to Discharge From Post-Anesthesia Care Unit (PACU)
Description
Time to readiness for discharge from the PACU. Patients were considered ready for PACU discharge when they met the following criteria: a) Awake, alert, oriented and responsive b) Minimal pain, Numeric Rating Scale < 5/10 (0 = no pain, 10 = worst imaginable pain) (parenteral [injected] medications not required) c) Vital signs stable d) No active bleeding e) Minimal or no nausea f) Not vomiting, tolerating oral intake g) Oxygen saturation > 94% (or baseline) on room air h) Patient has urinated.
Time Frame
Day of surgery prior to discharge
Title
Narcotic Pain Medication Needed
Time Frame
Day of surgery prior to discharge
Title
Incidence of Nausea
Description
The number of participants with nausea.
Time Frame
Day of surgery prior to discharge
Title
Incidence of Vomiting
Description
The number of participants who vomited.
Time Frame
Day of surgery prior to discharge
Title
Requirement of Antiemetic Rescue
Description
The number of participants who needed medication to treat their nausea and vomiting.
Time Frame
Day of surgery prior to discharge
Title
Patient Satisfaction
Description
Patient Satisfaction (0-10; 0 = very dissatisfied, 10 = very satisfied)
Time Frame
First 24 hours after surgery
Title
Quality of Recovery (QoR-40) Physical Comfort Dimension
Description
Assessment of Physical Comfort (minimum score = 12, maximum score = 60). Higher values represent a better outcome
Time Frame
First 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:
American Society of Anesthesiologists (ASA) Class 1-3
Patients aged 18 to 65 years
Patients scheduled for primary, unilateral arthroscopic hip surgery by Dr. Kelly, Dr. Coleman, or Dr. Anil Ranawat
Planned use of neuraxial anesthesia
Body Mass Index less than 35
Ability to follow study protocol
Exclusion Criteria:
Chronic opioid use (defined as daily or almost daily use of opioids for >3 months)
Contraindication to combined spinal-epidural anesthesia including but not limited to bleeding disorder, use of clinically relevant anticoagulant or antiplatelet medications, and anatomic abnormalities.
Contraindication to lumbar plexus block including but not limited to bleeding disorder, use of clinically relevant anticoagulant or antiplatelet medications, and anatomic abnormalities.
Infection at the injection site(s)
Allergy to any of the study medications
Contraindication to a short course of NSAIDs (renal failure, intolerance)
ASA Class 4-5
Patient refusal
Patients younger than 18 years old and older than 65
Patients with any known indwelling hardware of the lumbar spine.
Patients with a peripheral neuropathy of the surgical extremity
Non-English speaking patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques T YaDeau, M.D., Ph.D.
Organizational Affiliation
Hospital for Special Surgery, New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.hss.edu
Description
This is the link for the Hospital for Special Surgery website
Learn more about this trial
Lumbar Plexus Block for Postoperative Pain Control After Hip Arthroscopy. A Randomized Controlled Trial
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