Regional Anesthesia in Hip Arthroscopy

NCT ID: NCT02674113

Last Updated: 2017-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-10-31

Brief Summary

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The purpose of this research is to determine differences in outcomes in patients who receive regional anesthesia (a fascia iliaca block) versus placebo prior to undergoing hip arthroscopy with labral repair and/or debridement and osteoplasty for hip impingement.

Detailed Description

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Methods: After informed consent is obtained at a routine/pre-surgical clinic visit, all patients who meet eligibility criteria will undergo randomization into one of two groups. These groups are 1) to receive regional anesthesia (a single shot fascia iliaca block using bupivacaine) prior to hip arthroscopy, or 2) undergo a subcutaneous injection procedure using a normal saline placebo (0.9% sodium chloride in water) instead of bupivacaine. Intra-operatively, both groups will receive general anesthesia and local anesthesia (lidocaine and bupivacaine in the peripheral compartment).

Conditions

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Femoroacetabular Impingement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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regional anesthesia bupivacaine

regional anesthesia (a single shot fascia iliaca block using bupivacaine) prior to hip arthroscopy

Group Type ACTIVE_COMPARATOR

regional anesthesia bupivacaine

Intervention Type DRUG

a single shot fascia iliaca block using bupivacaine prior to hip arthroscopy

regional anesthesia placebo

subcutaneous injection procedure placebo (0.9% sodium chloride in water)

Group Type PLACEBO_COMPARATOR

regional anesthesia placebo

Intervention Type DRUG

subcutaneous injection procedure using a normal saline placebo (0.9% sodium chloride in water)

Interventions

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regional anesthesia bupivacaine

a single shot fascia iliaca block using bupivacaine prior to hip arthroscopy

Intervention Type DRUG

regional anesthesia placebo

subcutaneous injection procedure using a normal saline placebo (0.9% sodium chloride in water)

Intervention Type DRUG

Other Intervention Names

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Exparel Sensorcaine Marcaine Sodium Chloride Injection

Eligibility Criteria

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Inclusion Criteria

* Patient undergoing primary hip arthroscopy with labral repair and osteoplasty for hip impingement
* Age 18-45 years old
* Not pregnant
* No history of neuropathic pain
* No radiographic signs of osteoarthritis of the operative hip (Tönnisgrade 1)
* Willing and able to comply with post-operative hip arthroscopy protocol
* No documented allergy to anesthetic agents
* Able to attend follow up appointments

Exclusion Criteria

* Allergy to regional anesthetic
* Age \<18 or \>45 years
* Pregnant females
* History of neuropathic pain
* Radiographic signs of osteoarthritis (Tönnis grade 2)
* Unable to speak/understand English
* Currently imprisoned
* Unwilling/unable to provide consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Missouri-Columbia

OTHER

Sponsor Role lead

Responsible Party

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Ajay Aggarwal

Assistant Professor of Orthopedic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ajay Aggarwal, MD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri Health System

Locations

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University of Missouri Health System

Columbia, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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1211908

Identifier Type: -

Identifier Source: org_study_id

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