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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

Must not have

Renal or hepatic impairment or dysfunction

History of gastric bypass surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up to 2 years postoperative

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Drug Has Already Been Approved

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.

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.

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

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I am scheduled for shoulder replacement surgery at a Henry Ford hospital.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have kidney or liver problems.

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I have had gastric bypass surgery.

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I have been diagnosed with peptic ulcer disease.

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I am not allergic to any medications used in this study.

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I am taking blood thinner medication.

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I have had bleeding in my stomach or intestines.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ to 2 years postoperative

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain levels

Secondary study objectives

Complications

Morphine milligram equivalents

Patient-Reported Outcomes scores (PROMs) for depression

+5 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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

Magnesium

2010

Completed Phase 4

~1990

Dexamethasone

2007

Completed Phase 4

~2650