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OpenTrials
Completed

NCT Number: NCT04925791

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kerlan Jobe

Los Angeles, California, 90045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

standardized pre-conditioning treatment

Diagnostic Test

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

Partial occlusion

Diagnostic Test

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

Primary outcomes

  1. Pain levels VAS score

    Time frame: 7 days post op

    Pain score 0-10 with 0 being no pain and 10 being the worst

Secondary outcomes

  1. number of days opioids were consumed post op

    Time frame: 7 days post op

    Total number days the patient had to take pain medication

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 14, 2021
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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