Nonopioid Analgesia After Labral Surgery

ConditionNarcotic Use

Trial statusRecruiting

Trial phasePhase 2, Phase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorHenry Ford Health System

About 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

This trial accepts healthy volunteers

Qualifiers

All adult patients over age 18 and scheduled for a primary or revision labral surgery

Disqualifiers

Exclusion criteria will include patients with a medical history of known allergies or intolerance to allergies or intolerance to Celebrex, Tylenol, Neurontin, dexamethasone, tramadol, substantial alcohol or drug abuse, and pregnancy, history of narcotics within 6 months of surgery, renal impairment, peptic ulcer disease, GI bleeding. Secondary exclusion criterion is an intact rotator cuff

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: Post-Operative Non Opioid Pain ProtocolExperimental treatment 5 interventions

Group B: Post-Operative Traditional Pain ProtocolActive comparator 1 intervention

Trial outcomes

Primary outcomes

Pain Levels

Patients recorded pain levels 3 times per day using Visual analog scales until study completion. Average daily pain was calculated for each patient. Higher values portend worse control.

Time frame

10 days post-operatively

Patient-Reported Outcomes Measurement Information System

Patient-Reported Outcomes Measurement Information System Physical Interference (PROMIS PI) nightly until study completion. Average PROMIS PI values calculated nightly. A higher score indicates more pain interference.

Time frame

10 days post-operatively

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Henry Ford Health System

Lead sponsor

Source ClinicalTrials.gov

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