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

NCT ID: NCT04114058

Last Updated: 2021-05-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-29

Study Completion Date

2020-03-17

Brief Summary

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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

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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.

Conditions

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Femoro Acetabular Impingement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Liposomal Bupivicaine

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

Group Type ACTIVE_COMPARATOR

liposomal bupivicaine

Intervention Type DRUG

local field infiltration

fascia iliaca blockade

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

Group Type ACTIVE_COMPARATOR

Fascia iliaca blockade

Intervention Type PROCEDURE

fascia iliaca compartment blockade

Interventions

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liposomal bupivicaine

local field infiltration

Intervention Type DRUG

Fascia iliaca blockade

fascia iliaca compartment blockade

Intervention Type PROCEDURE

Other Intervention Names

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exparel

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cedars-Sinai Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Michael Banffy, MD

Director, Orthopaedic Sports Medicine Fellowship

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Banffy, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars Sinai

Locations

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Kerlan Jobe

Los Angeles, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 28802777 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24061718 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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Pro00056482

Identifier Type: -

Identifier Source: org_study_id

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