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Clinical Trials/NCT04114058
NCT04114058
Completed
Phase 4

Pain Outcomes Following Hip Arthroscopy: A Prospective Randomized Control Study Comparing Fascia Iliaca Blockade vs Extracapsular Local Field Infiltration With Liposomal Bupivacaine

Cedars-Sinai Medical Center1 site in 1 country37 target enrollmentOctober 29, 2019

Overview

Phase
Phase 4
Intervention
liposomal bupivicaine
Conditions
Femoro Acetabular Impingement
Sponsor
Cedars-Sinai Medical Center
Enrollment
37
Locations
1
Primary Endpoint
Visual Analogue Scale
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 29, 2019
End Date
March 17, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michael Banffy, MD

Director, Orthopaedic Sports Medicine Fellowship

Cedars-Sinai Medical Center

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

Arms & Interventions

Liposomal Bupivicaine

Following hip arthroscopy, local field infiltration with liposomal bupivicaine will be performed for adjunct pain control

Intervention: liposomal bupivicaine

fascia iliaca blockade

Preoperatively before hip arthroscopy, a fascia iliaca blockade will be performed for adjunct pain control

Intervention: Fascia iliaca blockade

Outcomes

Primary Outcomes

Visual Analogue Scale

Time Frame: post 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 Outcomes

  • Narcotic Utilization(total pill taken over the course of days 1-4 post op.)
  • Total Number of at Home Falls.(Post op days 1-7)

Study Sites (1)

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