Nonopioid Analgesia After Labral Surgery
Recruiting in Palo Alto (17 mi)
Overseen byToufic R Jildeh, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2 & 3
Recruiting
Sponsor: Henry Ford Health System
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?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
All adult patients over age 18 and scheduled for a primary or revision labral surgery
Participant Groups
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
Acetaminophen is already approved in United States, European Union, Canada, Australia for the following indications:
🇺🇸 Approved in United States as Tylenol for:
- Pain relief
- Fever reduction
🇪🇺 Approved in European Union as Paracetamol for:
- Pain relief
- Fever reduction
🇨🇦 Approved in Canada as Tylenol for:
- Pain relief
- Fever reduction
🇦🇺 Approved in Australia as Panadol for:
- Pain relief
- Fever reduction
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Henry Ford Health SystemDetroit, MI
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Who Is Running the Clinical Trial?
Henry Ford Health SystemLead Sponsor