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Opioid-Free Pain Protocol for Shoulder Surgery

Phase 4
Recruiting
Led By Stephanie J Muh, MD
Research Sponsored by Henry Ford Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Consented and scheduled for primary anatomic or reverse total shoulder arthroplasty at a Henry Ford hospital location
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up to 2 years postoperative
Awards & highlights

Study Summary

This trial is investigating whether a multimodal pain control regimen plus a standard prescription of an opioid containing medication is more effective than a multimodal pain control regimen alone for shoulder arthroplasty in terms of reducing pain.

Who is the study for?
This trial is for individuals scheduled for shoulder arthroplasty at a Henry Ford hospital who can communicate via text and understand English. They must not have allergies to study medications, recent narcotic use, gastrointestinal bleeding, liver or kidney issues, substance abuse problems, current/recent pregnancy, or be on blood thinners.Check my eligibility
What is being tested?
The trial tests the effectiveness of a multimodal pain control regimen without opioids against one with standard opioid medication after shoulder surgery. The main focus is on the difference in daily pain scores within the first 10 days post-operation.See study design
What are the potential side effects?
Possible side effects include stomach issues due to NSAIDs like Ibuprofen and Celecoxib; drowsiness from Tizanidine and Pregabalin; potential bleeding risks from Ketorolac; and common drug reactions such as nausea or allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for shoulder replacement surgery at a Henry Ford hospital.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~to 2 years postoperative
This trial's timeline: 3 weeks for screening, Varies for treatment, and to 2 years postoperative for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pain levels
Secondary outcome measures
Complications
Morphine milligram equivalents
Patient-Reported Outcomes scores (PROMs) for depression
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Multimodal, Non-NarcoticExperimental Treatment11 Interventions
This group will be given the preoperative, intraoperative, and discharge meds described below. This group will NOT receive any opioid-containing meds. Preoperative meds: Celecoxib: 400 mg by mouth, Pregabalin: 75 mg by mouth, Tramadol: 50 mg by mouth. Intraoperative meds: Dexamethasone: 10 mg IV, Acetaminophen: 1,000 mg IV, Ropivacaine 5 mg/mL (0.5%): 300 mg local infiltration, Epinephrine 1 mg/mL (1:1000): 1 mg local infiltration, Ketorolac 30 mg/mL: 30 mg local infiltration. Discharge meds: Dexamethasone: 4 mg by mouth twice per day for 4 days (for same day discharge only), 10 mg IV on postoperative day 1 (for overnight patients only), Pregabalin: 75 mg by mouth twice per day for 14 days, Tizanidine: 2 mg by mouth every 6 hours for 14 days, Magnesium: 200 mg by mouth twice per day for 14 days, Ibuprofen: 600 mg by mouth every 6 hours not to exceed 3200 mg per day for 1 month, Acetaminophen: 975 mg by mouth every 8 hours not to exceed 3000 mg per day for 1 month.
Group II: Multimodal Plus NarcoticActive Control12 Interventions
This group will be given the preop, intraop, and discharge meds described below. They will also be given 35 pills of oxycodone hydrochloride 5mg to be taken every 6 hours as needed at discharge. Preoperative: Celecoxib: 400 mg PO, Pregabalin: 75 mg PO, Tramadol: 50 mg PO. Intraoperative: Dexamethasone: 10 mg IV, Acetaminophen: 1,000 mg IV, Ropivacaine 5 mg/mL (0.5%): 300 mg local infiltration, Epinephrine 1 mg/mL (1:1000): 1 mg local infiltration, Ketorolac 30 mg/mL: 30 mg local infiltration. Discharge: Dexamethasone: 4 mg PO twice per day for 4 days (for same day discharge only), 10 mg IV on postop day 1 (for overnight patients only), Pregabalin: 75 mg PO twice per day for 14 days, Tizanidine: 2 mg PO every 6 hours for 14 days, Magnesium: 200 mg PO twice per day for 14 days, Ibuprofen: 600 mg PO every 6 hours not to exceed 3200 mg per day for 1 month, Acetaminophen: 975 mg PO every 8 hours not to exceed 3000 mg per day for 1 month.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Celecoxib
2019
Completed Phase 4
~1740
Ropivicaine
2014
Completed Phase 4
~340
Epinephrine
2014
Completed Phase 4
~3940
Ketorolac
2014
Completed Phase 4
~1760
Tizanidine
2016
Completed Phase 4
~630
Magnesium
2010
Completed Phase 4
~2980
Ibuprofen
2013
Completed Phase 4
~5800
Pregabalin
2005
Completed Phase 4
~6110
Tramadol
2014
Completed Phase 4
~3320
Dexamethasone
2007
Completed Phase 4
~2590
Acetaminophen
2017
Completed Phase 4
~2030

Find a Location

Who is running the clinical trial?

Henry Ford Health SystemLead Sponsor
300 Previous Clinical Trials
2,099,802 Total Patients Enrolled
Stephanie J Muh, MDPrincipal InvestigatorHenry Ford Health
1 Previous Clinical Trials
40 Total Patients Enrolled

Media Library

Opioid-Free Pain Protocol Clinical Trial Eligibility Overview. Trial Name: NCT05488847 — Phase 4
Shoulder Arthropathy Research Study Groups: Multimodal, Non-Narcotic, Multimodal Plus Narcotic
Shoulder Arthropathy Clinical Trial 2023: Opioid-Free Pain Protocol Highlights & Side Effects. Trial Name: NCT05488847 — Phase 4
Opioid-Free Pain Protocol 2023 Treatment Timeline for Medical Study. Trial Name: NCT05488847 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Federal Drug Administration sanctioned Acetaminophen?

"Our evaluation of Acetaminophen's safety merits a 3, since this treatment has been approved by the FDA and is currently in Phase 4 trials."

Answered by AI

What is the cap on the number of participants in this research study?

"Affirmative. Clinicaltrials.gov data reveals that this medical research, which was posted on June 25th 2022, is currently recruiting patients for participation. The trial requires 80 individuals to be enrolled across a sole site."

Answered by AI

Are there still opportunities to join this research study?

"Information on clinicaltrials.gov indicates that this experimental trial is actively recruiting patients as of October 25th 2022, after first being posted to the website in June of the same year."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
What site did they apply to?
Henry Ford Health
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Opioid-Free Pain Protocol After Shoulder Arthroplasty
Stephanie Muh, MD 2022. "Opioid-Free Pain Protocol After Shoulder Arthroplasty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05488847.
~19 spots leftby Dec 2024
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