Clinical trial NCT04114058: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Femoro Acetabular Impingement
Keywords: hip arthroscopy
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2019-10-03
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: post op days 1-4 (Average VAS score of first 4 days of post op)
Secondary outcomes:
measure: Narcotic Utilization
timeFrame: total pill taken over the course of days 1-4 post op.
measure: Total Number of at Home Falls.
timeFrame: Post op days 1-7
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Kerlan Jobe
state: California
Study officials:
affiliation: Cedars Sinai
name: Michael Banffy, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.