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A Study Comparing Fascia Iliaca Blockade vs Extracapsular Local Field Infiltration With Liposomal Bupivacaine

Phase 4
Completed
Conditions
Femoro Acetabular Impingement
Interventions
Procedure: Fascia iliaca blockade
Drug: liposomal bupivicaine
Registration Number
NCT04114058
Lead Sponsor
Cedars-Sinai Medical Center
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
37
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
fascia iliaca blockadeFascia iliaca blockadePreoperatively before hip arthroscopy, a fascia iliaca blockade will be performed for adjunct pain control
Liposomal Bupivicaineliposomal bupivicaineFollowing hip arthroscopy, local field infiltration with liposomal bupivicaine will be performed for adjunct pain control
Primary Outcome Measures
NameTimeMethod
Visual Analogue Scalepost op days 1-4 (Average VAS score of first 4 days of post op)

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
NameTimeMethod
Narcotic Utilizationtotal pill taken over the course of days 1-4 post op.

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.Post op days 1-7

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.

Trial Locations

Locations (1)

Kerlan Jobe

🇺🇸

Los Angeles, California, United States

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