Femoro Acetabular Impingement Clinical Trial
Official title:
Pain Outcomes Following Hip Arthroscopy: A Prospective Randomized Control Study Comparing Fascia Iliaca Blockade vs Extracapsular Local Field Infiltration With Liposomal Bupivacaine
Verified date | April 2021 |
Source | Cedars-Sinai Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 37 |
Est. completion date | March 17, 2020 |
Est. primary completion date | March 17, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Kerlan Jobe | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Cedars-Sinai Medical Center |
United States,
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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | post op days 1-4 (Average VAS score of first 4 days of post op) | |
Secondary | 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 pill taken over the course of days 1-4 post op. | |
Secondary | 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. | Post op days 1-7 |
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