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

Cedars-Sinai Medical Center logo

Cedars-Sinai Medical Center

Status and phase

Completed
Phase 4

Conditions

Femoro Acetabular Impingement

Treatments

Procedure: Fascia iliaca blockade
Drug: liposomal bupivicaine

Study type

Interventional

Funder types

Other

Identifiers

NCT04114058
Pro00056482

Details and patient eligibility

About

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

Full 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.

Enrollment

37 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

37 participants in 2 patient groups

Liposomal Bupivicaine
Active Comparator group
Description:
Following hip arthroscopy, local field infiltration with liposomal bupivicaine will be performed for adjunct pain control
Treatment:
Drug: liposomal bupivicaine
fascia iliaca blockade
Active Comparator group
Description:
Preoperatively before hip arthroscopy, a fascia iliaca blockade will be performed for adjunct pain control
Treatment:
Procedure: Fascia iliaca blockade

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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