A Prospective Analysis of Preoperative Fascia Iliaca Block for Hip Arthroscopy
Primary Purpose
Muscle Weakness | Patient, Pain
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Peripheral Nerve Block
Sham Block
Sponsored by
About this trial
This is an interventional treatment trial for Muscle Weakness | Patient
Eligibility Criteria
Inclusion Criteria:
- Age at least 18 years old
- American Society of Anesthesia physical classification I - III, scheduled for arthroscopic hip surgery
Exclusion Criteria:
- Age younger than 18 years old
- Non-English speaking
- Contraindicated for regional nerve block (such as, but not limited to: coagulopathy, infection at site, allergy to local anesthetic)
- Preexisting neurologic deficits of operative limb
- Need for postoperative nerve function test
- Inability to consent due to cognitive dysfunction
- Chronic pain
- Patient refusal.
Sites / Locations
- Orthopedic Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Sham
Fascia Iliaca Compartment Block
Arm Description
Outcomes
Primary Outcome Measures
Numeric Pain Score
highest reported numeric score 0-10 in Post Anesthesia Care Unit (PACU) (primary endpoint) The NRS score is used to rate pain from 0 (no pain) to 10 (worst pain imaginable)
Secondary Outcome Measures
Leg Strength at Discharge From Ambulatory Center, Surgical Leg
measurement of quadriceps strength (Force) using a dynamometer
Patient Satisfaction
patient questionaire, patients are contacted 48 h after surgery
patient satisfaction is assessed using a questionnaire, applying a scale from 0 to 10, with 0 indicating "not satisfied at all" and 10 indicating "very satisfied"
Full Information
NCT ID
NCT02623361
First Posted
December 1, 2015
Last Updated
December 6, 2018
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT02623361
Brief Title
A Prospective Analysis of Preoperative Fascia Iliaca Block for Hip Arthroscopy
Official Title
A Prospective Analysis of Preoperative Fascia Iliaca Block for Hip Arthroscopy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
February 2015 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Patients undergoing arthroscopic hip surgery have been shown to have significant post-operative pain that may delay discharge, recovery, and early mobilisation. A pre-operative regional anesthesia technique, the fascia iliaca block may be an effective method for acute post-operative analgesia.
This is a prospective, randomized controlled study of the preoperative fascia iliaca block for patients undergoing hip arthroscopy.
The enrolled patients will be randomized to receive either a fascia iliaca block with the local anesthetic ropivacaine or to have a sham block. All patients will receive a general anesthetic for the hip arthroscopy.
Detailed Description
Arthroscopic hip surgery is used to diagnose and treat interior joint pathology. Although minimally invasive in nature, patients have considerable amount of pain postoperatively, leading to prolonged recovery room stay and increased opiate requirements. The investigators performed a retrospective chart review in patients who underwent hip arthroscopy at the UCSF Orthopedic Institute. 89% of the patients had pain immediate after surgery requiring opioid therapy. Regional anesthesia has previously been shown to reduce discomfort after hip arthroscopy. However, there is currently no safe, well-established ultrasound guided regional anesthesia technique for arthroscopic hip surgery. The fascia iliaca block has shown to decrease acute pain related with hip fractures, as well as pain related with knee arthroplasty. The ultrasound guided fascia iliaca block is easy to perform and has an excellent safety record. The investigators believe that the ultrasound guided fascia iliaca block improves pain control in patients undergoing arthroscopic hip surgery.
Patients will receive a sham block group or a fascia iliaca block, performed in the preoperative area.
Pain scores and measurement of quadriceps strength will be assessed preoperatively and postoperatively. The patient will receive a pain diary consisting of pain scores, pain medication consumption, and a brief pain inventory. Within 48 hours postoperatively, an anesthesiologist will call the patient and review the patient's pain scores, pain medication consumption and brief pain inventory.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Weakness | Patient, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sham
Arm Type
Placebo Comparator
Arm Title
Fascia Iliaca Compartment Block
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Peripheral Nerve Block
Intervention Description
Regional Anesthesia by Local Anesthetic Injection
Intervention Type
Drug
Intervention Name(s)
Sham Block
Intervention Description
Sham Block by saline injection
Primary Outcome Measure Information:
Title
Numeric Pain Score
Description
highest reported numeric score 0-10 in Post Anesthesia Care Unit (PACU) (primary endpoint) The NRS score is used to rate pain from 0 (no pain) to 10 (worst pain imaginable)
Time Frame
within one hour after surgery
Secondary Outcome Measure Information:
Title
Leg Strength at Discharge From Ambulatory Center, Surgical Leg
Description
measurement of quadriceps strength (Force) using a dynamometer
Time Frame
2 hours after surgery
Title
Patient Satisfaction
Description
patient questionaire, patients are contacted 48 h after surgery
patient satisfaction is assessed using a questionnaire, applying a scale from 0 to 10, with 0 indicating "not satisfied at all" and 10 indicating "very satisfied"
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age at least 18 years old
American Society of Anesthesia physical classification I - III, scheduled for arthroscopic hip surgery
Exclusion Criteria:
Age younger than 18 years old
Non-English speaking
Contraindicated for regional nerve block (such as, but not limited to: coagulopathy, infection at site, allergy to local anesthetic)
Preexisting neurologic deficits of operative limb
Need for postoperative nerve function test
Inability to consent due to cognitive dysfunction
Chronic pain
Patient refusal.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthias Behrends, MD
Organizational Affiliation
University of California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orthopedic Institute
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
12. IPD Sharing Statement
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A Prospective Analysis of Preoperative Fascia Iliaca Block for Hip Arthroscopy
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