Does Limb Pre-Conditioning Reduce Pain After Hip Arthroscopy

NCT ID: NCT04925791

Last Updated: 2024-08-20

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

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-18

Study Completion Date

2023-10-20

Brief Summary

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The purpose of this study is to determine if the utilization of Ischemic Pre-Conditioning 24-hours prior to hip arthroscopy decreases patient's post-operative pain and opioid consumption.

Detailed Description

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Subjects will be asked to take part in one of two treatment procedures 24 hours prior to their scheduled hip arthroscopy date. Subjects will be randomized into either the IPC or CON group.

These treatments consist of either 3 rounds of 5 minutes of occlusion alternating with 5 minutes of reperfusion or 3 rounds of 5 minutes of minimal occlusion alternating with 5 minutes of reperfusion. The treatment will last 30 minutes. Days 0-7 post-op will consist of self-reported pain scales and opioid consumption documentation in the morning and evening. This is a randomized single-blind research study.

This study has two study groups:

* The IPC group will get a standardized pre-conditioning treatment 24 hours prior to their hip arthroscopy. This consists of 3 rounds of 5 minutes of occlusion alternating with 5 minutes of reperfusion while seated.
* The CON group will get a controlled treatment of 20% of limb occlusion pressure 24 hours prior to their hip arthroscopy. This consists of 3 rounds of 5 minutes of minimal occlusion alternating with 5 minutes of reperfusion while seated.

Conditions

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Hip Injuries Hip Dislocation Hip Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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The IPC group

subjects will get a standardized pre-conditioning treatment 24 hours prior to their hip arthroscopy. This consists of 3 rounds of 5 minutes of occlusion alternating with 5 minutes of reperfusion while seated.

Group Type EXPERIMENTAL

standardized pre-conditioning treatment

Intervention Type DIAGNOSTIC_TEST

3 rounds of 5 minutes of full occlusion alternating with 5 minutes of reperfusion while seated.

The CON group

subjects will get a controlled treatment of 20% of limb occlusion pressure 24 hours prior to their hip arthroscopy. This consists of 3 rounds of 5 minutes of minimal occlusion alternating with 5 minutes of reperfusion while seated.

Group Type OTHER

Partial occlusion

Intervention Type DIAGNOSTIC_TEST

3 rounds of 5 minutes of partial occlusion alternating with 5 minutes of reperfusion while seated.

Interventions

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standardized pre-conditioning treatment

3 rounds of 5 minutes of full occlusion alternating with 5 minutes of reperfusion while seated.

Intervention Type DIAGNOSTIC_TEST

Partial occlusion

3 rounds of 5 minutes of partial occlusion alternating with 5 minutes of reperfusion while seated.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing a primary hip arthroscopy by the PI between the ages of 18 and 55.

Exclusion Criteria

* Patients younger than 18 or older than 55 who have had a previous hip arthroscopy, venous thromboembolism, and/or who take medications and/or supplements known to increase the risk of blood clots.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cedars-Sinai Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Michael Banffy, MD

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Banffy, MD

Role: PRINCIPAL_INVESTIGATOR

Cedar Sinai -Kerlan Jobe

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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Orner C, Usoro A, Bergeron B, Banffy M. Does Ischemic Preconditioning of the Operative Limb Reduce Pain After Hip Arthroscopy? A Prospective, Single-Blind, Randomized Controlled Trial. Orthop J Sports Med. 2025 Jun 10;13(6):23259671251343762. doi: 10.1177/23259671251343762. eCollection 2025 Jun.

Reference Type DERIVED
PMID: 40502719 (View on PubMed)

Other Identifiers

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STUDY00001182

Identifier Type: -

Identifier Source: org_study_id

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