NCT04114058

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2019

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2019

Completed
29 days until next milestone

First Posted

Study publicly available on registry

October 3, 2019

Completed
26 days until next milestone

Study Start

First participant enrolled

October 29, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2020

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

May 11, 2021

Completed
Last Updated

May 11, 2021

Status Verified

April 1, 2021

Enrollment Period

5 months

First QC Date

September 4, 2019

Results QC Date

March 9, 2021

Last Update Submit

April 19, 2021

Conditions

Femoro Acetabular Impingement

Keywords

hip arthroscopy

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale

    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.

    post op days 1-4 (Average VAS score of first 4 days of post op)

Secondary Outcomes (2)

  • 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 Arms (2)

Liposomal Bupivicaine

ACTIVE COMPARATOR

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

Drug: liposomal bupivicaine

fascia iliaca blockade

ACTIVE COMPARATOR

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

Procedure: Fascia iliaca blockade

Interventions

liposomal bupivicaineDRUG

local field infiltration

Also known as: exparel
Liposomal Bupivicaine
Fascia iliaca blockadePROCEDURE

fascia iliaca compartment blockade

fascia iliaca blockade

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients (\>18 years old)
  • diagnosed FAI that are indicated for hip arthroscopic labral repair and femoroplasty/acetabuloplasty.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kerlan Jobe

Los Angeles, California, 90045, United States

Location

Related Publications (2)

  • 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.

    PMID: 28802777BACKGROUND

  • 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.

    PMID: 24061718BACKGROUND

MeSH Terms

Conditions

Femoracetabular Impingement

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

We did not meet target enrollment due to safety concerns.

Results Point of Contact

Title
Dr. Michael Banffy
Organization
Cedar Sinai -Kerlan Jobe
Michael.Banffy@cskerlanjobe.org
(310) 665-7200

Study Officials

  • Michael Banffy, MD

    Cedars Sinai

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Orthopaedic Sports Medicine Fellowship

Study Record Dates

First Submitted

September 4, 2019

First Posted

October 3, 2019

Study Start

October 29, 2019

Primary Completion

March 17, 2020

Study Completion

March 17, 2020

Last Updated

May 11, 2021

Results First Posted

May 11, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)