Does Limb Pre-Conditioning Reduce Pain After Hip Arthroscopy

August 19, 2024 updated by: Michael Banffy, MD, Cedars-Sinai Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90045
        • Kerlan Jobe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Diagnostic test: standardized pre-conditioning treatment
3 rounds of 5 minutes of full occlusion alternating with 5 minutes of reperfusion while seated.
Other: 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.
Diagnostic test: Partial occlusion
3 rounds of 5 minutes of partial occlusion alternating with 5 minutes of reperfusion while seated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain levels VAS score
Time Frame: 7 days post op
Pain score 0-10 with 0 being no pain and 10 being the worst
7 days post op

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of days opioids were consumed post op
Time Frame: 7 days post op
Total number days the patient had to take pain medication
7 days post op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedars-Sinai Medical Center

Investigators

  • Principal Investigator: Michael Banffy, MD, Cedar Sinai -Kerlan Jobe

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2021

Primary Completion (Actual)

October 20, 2023

Study Completion (Actual)

October 20, 2023

Study Registration Dates

First Submitted

June 9, 2021

First Submitted That Met QC Criteria

June 9, 2021

First Posted (Actual)

June 14, 2021

Study Record Updates

Last Update Posted (Actual)

August 20, 2024

Last Update Submitted That Met QC Criteria

August 19, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00001182

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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