Does Limb Pre-Conditioning Reduce Pain After Hip Arthroscopy

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: Active, not recruiting
• Conditions: Hip Fractures; Hip Injuries; Hip Dislocation
• Intervention / Treatment: Diagnostic test: standardized pre-conditioning treatment; Diagnostic test: Partial occlusion

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

• Study Contact: Name: Brooke Bergeron, ATC; Phone Number: 6203 310 6657200; Email: Brooke.bergeron@cskerlanjobe.org

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	Total number days the patient had to take pain medication	7 days post op

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Investigators: Principal Investigator: Michael Banffy, MD, Cedar Sinai -Kerlan Jobe

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2021
• Primary Completion (Estimated): May 11, 2024
• Study Completion (Estimated): May 11, 2024

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): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Joint Diseases; Musculoskeletal Diseases; Femoral Fractures; Joint Dislocations; Hip Fractures; Hip Dislocation; Hip Injuries
• 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