A Study Comparing Fascia Iliaca Blockade vs Extracapsular Local Field Infiltration With Liposomal Bupivacaine
Primary Purpose
Femoro Acetabular Impingement
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
liposomal bupivicaine
Fascia iliaca blockade
Sponsored by
About this trial
This is an interventional treatment trial for Femoro Acetabular Impingement focused on measuring hip arthroscopy
Eligibility Criteria
Inclusion Criteria:
- adult patients (>18 years old)
- diagnosed FAI that are indicated for hip arthroscopic labral repair and femoroplasty/acetabuloplasty.
Exclusion Criteria:
- patients undergoing revision procedures, bilateral procedures,
- advanced osteoarthritis (<2mm joint space on plain radiographs)
- frank dysplasia (anterior and/or lateral center edge angles <20 degrees and/or Tonnis angle >15 degrees)
- diagnoses other than FAI (Legg Calve Perthes, femoral head avascular necrosis, septic arthritis, or post traumatic deformity).
- allergy to liposomal bupivicaine
Sites / Locations
- Kerlan Jobe
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Liposomal Bupivicaine
fascia iliaca blockade
Arm Description
Following hip arthroscopy, local field infiltration with liposomal bupivicaine will be performed for adjunct pain control
Preoperatively before hip arthroscopy, a fascia iliaca blockade will be performed for adjunct pain control
Outcomes
Primary Outcome Measures
Visual Analogue Scale
pain scale Questionnaire 0 equals no pain at all and 10 equals the worst. The out come measure time frame is reported as the average VAS score of the first 4 day post op.
Secondary Outcome Measures
Narcotic Utilization
Record of number of narcotic pain pills utilized by patients . This was reported as a total from post op day 1 to 4. The number listed is an average from each patient, from the total pills taken at home.
Total Number of at Home Falls.
number of falls occurring at home after discharge. This is the total number of falls of all patients in each group, over the first 7 days post op. This is not reported as a mean.
Full Information
NCT ID
NCT04114058
First Posted
September 4, 2019
Last Updated
April 19, 2021
Sponsor
Cedars-Sinai Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04114058
Brief Title
A Study Comparing Fascia Iliaca Blockade vs Extracapsular Local Field Infiltration With Liposomal Bupivacaine
Official Title
Pain Outcomes Following Hip Arthroscopy: A Prospective Randomized Control Study Comparing Fascia Iliaca Blockade vs Extracapsular Local Field Infiltration With Liposomal Bupivacaine
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 29, 2019 (Actual)
Primary Completion Date
March 17, 2020 (Actual)
Study Completion Date
March 17, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center
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.
Yes
5. Study Description
Brief Summary
The purpose of this study is to compare the effectiveness of fascia iliaca blockade vs local field infiltration with liposomal bupivicaine in controlling pain, narcotic utilization and falls in the postoperative period following hip arthroscopy
Detailed Description
The purpose the research is to help determine optimal means of post-operative analgesia following hip arthroscopic procedures. Post-operative pain is a significant contributor to patient satisfaction and the side effects of narcotic pain medication are well described. The ideal intervention for achieving appropriate analgesia following hip arthroscopy has not yet been defined. Determining means of achieving acceptable post-operative pain relief while minimizing narcotic usage will help yield maximal patient outcomes.The primary research procedures entailed in this study include fascia iliaca nerve blockade with Marcaine and local field infiltration with liposomal bupivicane (Exparel). The patients in this study will include those who have both a clinical and radiographic diagnosis of femoracetabular impingement (FAI), have failed non operative treatment, and are indicated for hip arthroscopy with labral repair and femoroplasty/acetabuloplasty. The study includes the surgical procedure and the first post-operative follow up visit. The total study duration is approximately 1.5 weeks for each patient. The study will be carried out until the patients first post-operative visit which typically occurs 7-10 days after the procedure. We are to include approximately 40 patients in total for this study over a period of 4 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoro Acetabular Impingement
Keywords
hip arthroscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Liposomal Bupivicaine
Arm Type
Active Comparator
Arm Description
Following hip arthroscopy, local field infiltration with liposomal bupivicaine will be performed for adjunct pain control
Arm Title
fascia iliaca blockade
Arm Type
Active Comparator
Arm Description
Preoperatively before hip arthroscopy, a fascia iliaca blockade will be performed for adjunct pain control
Intervention Type
Drug
Intervention Name(s)
liposomal bupivicaine
Other Intervention Name(s)
exparel
Intervention Description
local field infiltration
Intervention Type
Procedure
Intervention Name(s)
Fascia iliaca blockade
Intervention Description
fascia iliaca compartment blockade
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
pain scale Questionnaire 0 equals no pain at all and 10 equals the worst. The out come measure time frame is reported as the average VAS score of the first 4 day post op.
Time Frame
post op days 1-4 (Average VAS score of first 4 days of post op)
Secondary Outcome Measure Information:
Title
Narcotic Utilization
Description
Record of number of narcotic pain pills utilized by patients . This was reported as a total from post op day 1 to 4. The number listed is an average from each patient, from the total pills taken at home.
Time Frame
total pill taken over the course of days 1-4 post op.
Title
Total Number of at Home Falls.
Description
number of falls occurring at home after discharge. This is the total number of falls of all patients in each group, over the first 7 days post op. This is not reported as a mean.
Time Frame
Post op days 1-7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients (>18 years old)
diagnosed FAI that are indicated for hip arthroscopic labral repair and femoroplasty/acetabuloplasty.
Exclusion Criteria:
patients undergoing revision procedures, bilateral procedures,
advanced osteoarthritis (<2mm joint space on plain radiographs)
frank dysplasia (anterior and/or lateral center edge angles <20 degrees and/or Tonnis angle >15 degrees)
diagnoses other than FAI (Legg Calve Perthes, femoral head avascular necrosis, septic arthritis, or post traumatic deformity).
allergy to liposomal bupivicaine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Banffy, MD
Organizational Affiliation
Cedars Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kerlan Jobe
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28802777
Citation
Mont MA, Beaver WB, Dysart SH, Barrington JW, Del Gaizo DJ. Local Infiltration Analgesia With Liposomal Bupivacaine Improves Pain Scores and Reduces Opioid Use After Total Knee Arthroplasty: Results of a Randomized Controlled Trial. J Arthroplasty. 2018 Jan;33(1):90-96. doi: 10.1016/j.arth.2017.07.024. Epub 2017 Jul 25. Erratum In: J Arthroplasty. 2019 Feb;34(2):399-400.
Results Reference
background
PubMed Identifier
24061718
Citation
Krych AJ, Baran S, Kuzma SA, Smith HM, Johnson RL, Levy BA. Utility of multimodal analgesia with fascia iliaca blockade for acute pain management following hip arthroscopy. Knee Surg Sports Traumatol Arthrosc. 2014 Apr;22(4):843-7. doi: 10.1007/s00167-013-2665-y. Epub 2013 Sep 24.
Results Reference
background
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A Study Comparing Fascia Iliaca Blockade vs Extracapsular Local Field Infiltration With Liposomal Bupivacaine
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