Back to resultsDoes Limb Pre-Conditioning Reduce Pain After Hip Arthroscopy
Primary Purpose
Hip Injuries, Hip Dislocation, Hip Fractures
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
standardized pre-conditioning treatment
Partial occlusion
Sponsored by
About this trial
This is an interventional treatment trial for Hip Injuries
Eligibility Criteria
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.
Sites / Locations
- Kerlan JobeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
The IPC group
The CON group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Pain levels VAS score
Pain score 0-10 with 0 being no pain and 10 being the worst
Secondary Outcome Measures
number of days opioids were consumed post op
Total number days the patient had to take pain medication
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04925791
Brief Title
Does Limb Pre-Conditioning Reduce Pain After Hip Arthroscopy
Official Title
Does Limb Pre-Conditioning Reduce Pain After Hip Arthroscopy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 11, 2021 (Anticipated)
Primary Completion Date
May 11, 2023 (Anticipated)
Study Completion Date
May 11, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center
4. Oversight
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
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Injuries, Hip Dislocation, Hip Fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
The IPC group
Arm Type
Experimental
Arm Description
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.
Arm Title
The CON group
Arm Type
Other
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
standardized pre-conditioning treatment
Intervention Description
3 rounds of 5 minutes of full occlusion alternating with 5 minutes of reperfusion while seated.
Intervention Type
Diagnostic Test
Intervention Name(s)
Partial occlusion
Intervention Description
3 rounds of 5 minutes of partial occlusion alternating with 5 minutes of reperfusion while seated.
Primary Outcome Measure Information:
Title
Pain levels VAS score
Description
Pain score 0-10 with 0 being no pain and 10 being the worst
Time Frame
7 days post op
Secondary Outcome Measure Information:
Title
number of days opioids were consumed post op
Description
Total number days the patient had to take pain medication
Time Frame
7 days post op
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brooke Bergeron, ATC
Phone
310 6657200
Ext
6203
Email
Brooke.bergeron@cskerlanjobe.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Banffy, MD
Organizational Affiliation
Cedar Sinai -Kerlan Jobe
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kerlan Jobe
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brooke Bergeron, ATC
Phone
310-665-7200
Ext
6203
Email
Brooke.bergeron@cskerlanjobe.org
12. IPD Sharing Statement
Learn more about this trial
Does Limb Pre-Conditioning Reduce Pain After Hip Arthroscopy
We'll reach out to this number within 24 hrs