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drugset / Trial / NCT05488847

Opioid-Free Pain Protocol After Shoulder Arthroplasty

NCT05488847 ↗

Phase 4 Active not recruiting 83 enrolled Henry Ford Health System
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2022-06-25
Primary completion
2024-12-11
Completion
2026-09-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Oxycodone Other / unclassified 5 mg —
Background Acetaminophen Small molecule 975 mg Intravenous
Background Celecoxib Other / unclassified 400 mg Oral
Background Dexamethasone Small molecule 4 mg Oral
Background Epinephrine Other / unclassified 1 mg Other
Background Ibuprofen Small molecule 600 mg Oral
Background Ketorolac Other / unclassified 30 mg Other
Background Magnesium Sulfate Other / unclassified 200 mg Oral
Background Pregabalin Small molecule 75 mg Oral
Background Ropivacaine Other / unclassified 300 mg Other
Background Tizanidine Small molecule 2 mg Oral
Background Tramadol Other / unclassified 50 mg Oral

Indications

arthropathy