Cold and Compression for Postoperative Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to compare pain score (Patient-Reported Outcomes Measurement Information System: PROMIS NRS Pain Subscale) between the control and cold/compression groups pre-surgically, daily after surgery for 14 days, then weekly after surgery for 3 months, and at 6 months post-surgery.
Who Is on the Research Team?
Michael Hartman, MD
Principal Investigator
Ochsner Medical Center - Kenner
Paul Phillips, MD
Principal Investigator
Ochsner Medical Center - Kenner
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-surgical
Participants are assessed pre-surgically for baseline pain scores
Post-surgical Treatment
Participants receive either standard care or cold and compression therapy post-surgery
Extended Monitoring
Weekly monitoring of pain scores for 3 months post-surgery
Follow-up
Participants are monitored for safety and effectiveness at 6 months post-surgery
What Are the Treatments Tested in This Trial?
Interventions
- Cold and Compression
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Patients in this arm will be discharged with 28 hydrocodone/APAP 7.5 mg pills taken every 6 hours as needed (or its MME equivalent), 1 identical refill if patient calls, and cold \& compression therapy device provided by Sponsor)
Patients in this arm will receive standard therapy post-surgery and discharged with 28 hydrocodone/APAP 7.5 mg pills taken every 6 hours as needed (or its MME equivalent), 1 identical refill if patient calls, and cold therapy (bag of ice or gel pack)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ochsner Health System
Lead Sponsor
BREG, Inc
Industry Sponsor
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