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Opioid-Free Pain Protocol After Shoulder Arthroplasty

StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Results first posted: Feb 10, 2026
    • Secondary endpoints revised (7)
    v8
  2. Primary endpoints: 1 to 2
    • Enrollment target: estimated 80 to confirmed 83
    • Secondary endpoints: 8 to 7
    v7
  3. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Dec 1, 2024 to Dec 11, 2024
    • Study completion date: Dec 1, 2025 to Sep 1, 2026
    • Site details revised
    v6
  4. Primary completion date: Dec 1, 2023 to Dec 1, 2024v5
  5. 2 versions Re-verified since Jun 13, 2023, no change to tracked fieldsv3-v4
  6. Interventions: Acetaminophen (Drug), Celecoxib (Drug), Dexamethasone (Drug), Epinephrine (Drug), Ibuprofen (Drug), Oxycodone Hydrochloride 5 Mg… to Acetaminophen (Drug), Celecoxib (Drug), Dexamethasone (Drug), Epinephrine (Drug), Ibuprofen (Drug), Ketorolac (Drug), Magnesium (Drug)…
    • Study description revised
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05488847
Lead Sponsor Henry Ford Health System
Conditions
(from sponsor)		 Shoulder Arthropathy, Shoulder Pain
Related terms Shoulder Pain
Enrollment 83 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov