Does Limb Pre-Conditioning Reduce Pain After Hip Arthroscopy

Hip Fractures Clinical Trial

Official title:

Does Limb Pre-Conditioning Reduce Pain After Hip Arthroscopy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04925791
• Other study ID #: STUDY00001182
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 18, 2021
• Est. completion date: May 11, 2024

Study information

• Verified date: February 2024
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 68
• Est. completion date: May 11, 2024
• Est. primary completion date: May 11, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hip Dislocation
• Hip Fractures
• Hip Injuries

Intervention

Diagnostic Test:
• standardized pre-conditioning treatment
3 rounds of 5 minutes of full occlusion alternating with 5 minutes of reperfusion while seated.
• Partial occlusion
3 rounds of 5 minutes of partial occlusion alternating with 5 minutes of reperfusion while seated.

Locations

Country	Name	City	State
United States	Kerlan Jobe	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain levels VAS score	Pain score 0-10 with 0 being no pain and 10 being the worst	7 days post op
Secondary	number of days opioids were consumed post op	Total number days the patient had to take pain medication	7 days post op