Hip Scope Fascia-iliaca (FI) Block Study

NCT ID: NCT02365961

Last Updated: 2019-03-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-06-30

Brief Summary

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Patients undergoing a hip scope procedure will be recruited for this study. They will be randomized to either receive a nerve block or no nerve block (pain medicine only). Pain levels and clinical outcomes will be assessed through 3 months post-operatively.

Detailed Description

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Conditions

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Hip Dysplasia Femoroacetabular Impingement Acetabular Labrum Tear

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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FI Block

Fascia iliaca block consisting of up to 60 mL of 0.35% ropivicaine at a dose of 3 mg/kg (with adjuvants of 100 mcg clonidine \[per 60 mL\] and epinephrine 1:400,000)

Group Type EXPERIMENTAL

ropivicaine

Intervention Type DRUG

clonidine

Intervention Type DRUG

Epinephrine

Intervention Type DRUG

Local Injection

Local anesthetic in the hip joint consisting of 30cc of 0.5% Noropin

Group Type ACTIVE_COMPARATOR

Noropin

Intervention Type DRUG

Interventions

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ropivicaine

Intervention Type DRUG

clonidine

Intervention Type DRUG

Epinephrine

Intervention Type DRUG

Noropin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Scheduled for outpatient hip arthroscopy
* American Society of Anesthesiologists (ASA) 1-3

Exclusion Criteria

* Prior surgery on ipsilateral hip
* ASA 4-6
* Chronic narcotic usage over 6 months or more than the equivalent of 20mg of morphine per day
* Current or prior placement of a spinal cord stimulator or intrathecal pump for pain control purposes
* Allergy to amide local anesthetics
* Contraindication to regional anesthesia
* BMI \> 40
* Females who are pregnant or plan to get pregnant during the course of the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hawkins Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eugene Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Greenville Anesthesiology - Greenville Health System

Locations

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Steadman Hawkins Clinic of the Carolinas - Greenville Health System

Greenville, South Carolina, United States

Site Status

Countries

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United States

References

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Glomset JL, Kim E, Tokish JM, Renfro SD, Seckel TB, Adams KJ, Folk J. Reduction of Postoperative Hip Arthroscopy Pain With an Ultrasound-Guided Fascia Iliaca Block: A Prospective Randomized Controlled Trial. Am J Sports Med. 2020 Mar;48(3):682-688. doi: 10.1177/0363546519898205. Epub 2020 Jan 30.

Reference Type DERIVED
PMID: 31999469 (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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Pro00038232

Identifier Type: -

Identifier Source: org_study_id

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