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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04925791
Other study ID # STUDY00001182
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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