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Nonopioid Analgesia
Post-Operative Non Opioid Pain Protocol for Drug Abuse
Phase 2 & 3
Recruiting
Led By Toufic R Jildeh, MD
Research Sponsored by Henry Ford Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All adult patients over age 18 and scheduled for a primary or revision labral surgery
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 days post-operatively
Awards & highlights
Study Summary
This is a randomized, single blinded, standard of care controlled clinical trial. This project aims to compare postoperative pain control in patients in two treatment arms of rotator cuff repair: a treatment group given a nonopioid pain control regimen, and a standard of care control group given standard opioid pain control regimen
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 days post-operatively
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 days post-operatively
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain Levels
Patient-Reported Outcomes Measurement Information System
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Post-Operative Non Opioid Pain ProtocolExperimental Treatment5 Interventions
Patients will be administered a post-operative non-opioid pain protocol consisting of:
Celecoxib Ketorolac Gabapentin Acetaminophen Diazepam
Group II: Post-Operative Traditional Pain ProtocolActive Control1 Intervention
Patients will be administered a traditional post-operative pain protocol consisting of: Hydrocodone-acetaminophen 5-325
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Celecoxib
FDA approved
Gabapentin
FDA approved
Acetaminophen
FDA approved
Diazepam
FDA approved
Ketorolac
FDA approved
Find a Location
Who is running the clinical trial?
Henry Ford Health SystemLead Sponsor
299 Previous Clinical Trials
2,098,647 Total Patients Enrolled
Toufic R Jildeh, MDPrincipal InvestigatorHenry Ford Health System
3 Previous Clinical Trials
223 Total Patients Enrolled
Frequently Asked Questions
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