Active — Not RecruitingPhase 4

Opioid-Free Pain Protocol After Shoulder Arthroplasty

United States83 participantsStarted 2022-06-25

Plain-language summary

This randomized, single blinded, clinical trial aims to investigate the efficacy of a multimodal pain control regimen for shoulder arthroplasty. Patients who receive a multimodal pain control regimen alone (study group) will be compared to patients who receive a multimodal pain control regimen plus a standard prescription of an opioid containing medication (comparison group). The primary outcome is average daily Numerical Rating Scale (NRS) pain score in the first 10 days after surgery. We hypothesize that there will be no significant difference in the primary outcome between the two groups.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Consented and scheduled for primary anatomic or reverse total shoulder arthroplasty at a Henry Ford hospital location Exclusion Criteria: * Unable to receive or reply to mobile phone text messages. * Unable to read or speak English * Medical history of known allergies or intolerance to any of the medications prescribed as a part of this study (ie, Percocet, Ibuprofen, Pregabalin, Dexamethasone, Acetaminophen, Tizanidine, Magnesium, Celecoxib, Tramadol, Ropivacaine, Epinephrine, Ketorolac) * Substantial alcohol or drug abuse * Recent or current pregnancy * History of narcotic use within 3 months prior to surgery * Renal or hepatic impairment or dysfunction * Use of blood thinner medication * Peptic ulcer disease * Gastrointestinal bleeding * History of gastric bypass surgery

What they're measuring

Pain Levels

Timeframe: The first 10 days postoperatively

Morphine Milligram Equivalents

Timeframe: The first 10 days postoperatively.

Trial details

NCT IDNCT05488847

SponsorHenry Ford Health System

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-11

Results submitted2025-12-12