Opioid-Free Pain Protocol After Shoulder Arthroplasty

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.

Conditions

• Shoulder Arthropathy
• Shoulder Pain

Interventions

DRUG

Celecoxib

preoperative pain medication given to all patients

DRUG

Pregabalin

preoperative and discharge pain medication given to all patients

DRUG

Tramadol

preoperative pain medication given to all patients

DRUG

Dexamethasone

Intraoperative and discharge pain medication given to all patients

DRUG

Acetaminophen

Intraoperative and discharge pain medication given to all patients

DRUG

Ropivicaine

Intraoperative pain medication given to all patients

DRUG

Epinephrine

Intraoperative pain medication given to all patients

DRUG

Ketorolac

Intraoperative pain medication given to all patients

DRUG

Tizanidine

Discharge pain medication given to all patients

DRUG

Magnesium

Discharge pain medication given to all patients

DRUG

Ibuprofen

Discharge pain medication given to all patients

DRUG

Oxycodone Hydrochloride 5 Mg

Only given to active comparator group

Sponsors & Collaborators

• Henry Ford Health System

  lead OTHER

Principal Investigators

• Stephanie J Muh, MD · Henry Ford Health

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-06-25

Primary Completion

2024-12-11

Completion

2026-09-01

FDA Drug

Yes

Countries

• United States

Study Locations