Nonopioid Analgesia After Labral Surgery

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Henry Ford Health System
Study ID
NCT03825809
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Narcotic Use

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Celecoxib — DRUG
    Post-Operative Non Opioid Pain Protocol
  • Hydrocodone-Acetaminophen — DRUG
    Traditionally used narcotic pain protocol
  • Ketorolac — DRUG
    Post-Operative Non Opioid Pain Protocol
  • Gabapentin — DRUG
    Post-Operative Non Opioid Pain Protocol
  • Acetaminophen — DRUG
    Post-Operative Non Opioid Pain Protocol
  • Diazepam — DRUG
    Post-Operative Non Opioid Pain Protocol

Study Details

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

Key Dates

Start date
Jan 22, 2019
Status verified
Jan 2019
Primary completion
Jan 20, 2020
Completion
May 20, 2020

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Post-Operative Non Opioid Pain Protocol
    Patients will be administered a post-operative non-opioid pain protocol consisting of: Celecoxib Ketorolac Gabapentin Acetaminophen Diazepam
  • Active Comparator: Post-Operative Traditional Pain Protocol
    Patients will be administered a traditional post-operative pain protocol consisting of: Hydrocodone-acetaminophen 5-325

Primary Outcome Measure

Pain Levels [ Time Frame: 10 days post-operatively ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Henry Ford Health SystemDetroitMichigan48202
Toufic R Jildeh, MD

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Henry Ford Health System· Detroit, MI

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