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Nonopioid Analgesia
Nonopioid Analgesia After Labral Surgery
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
Approved for 10 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pain Levels
Patient-Reported Outcomes Measurement Information System
Awards & Highlights
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
311 Previous Clinical Trials
2,176,293 Total Patients Enrolled
Toufic R Jildeh, MDPrincipal InvestigatorHenry Ford Health System
3 Previous Clinical Trials
193 Total Patients Enrolled