Opioid-Free Pain Protocol After Shoulder Arthroplasty

NCT05488847 | Active Not Recruiting Phase 4 Results FDA Drug

• 1 other identifier: 15592
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Pain Levels

  Patients record pain levels using a Visual analog scale for 10 days post-operatively. On each day, patients report their pain level via an automated text messaging service in the morning, afternoon, and the evening. A mean pain level is calculated from all scores reported by a patient in the first 10 days postoperatively. Patients will use a 0-10 scale along with visuals to indicate their level of pain with 0 being no pain at all and 10 being the worst pain possible. Lower scores indicate better outcomes.

  The first 10 days postoperatively

• Morphine Milligram Equivalents

  The morphine milligram equivalents (MMEs) of opioids consumed will be recorded.

  The first 10 days postoperatively.

Secondary Outcomes (7)

• Patient-Reported Outcomes Scores (PROMs) for Upper Extremity Pain Interference

  Preoperatively, 10 days postoperatively, 6 weeks postoperatively, and 3 months postoperatively

• Patient-Reported Outcomes Scores (PROMs) for Upper Extremity Function

  Preoperatively, 6 weeks postoperatively, and 3 months postoperatively

• Patient-Reported Outcomes Scores (PROMs) for Depression

  Preoperatively, 6 weeks postoperatively, and 3 months postoperatively

• American Shoulder and Elbow Score

  Preoperatively, 6 weeks postoperatively, and 3 months postoperatively

• Shoulder Arthroplasty Smart Score (SAS)

  preoperatively; 6 weeks postoperatively; 3 months postoperatively

Study Arms (2)

Multimodal, Non-Narcotic

EXPERIMENTAL

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.

Drug: Celecoxib; Drug: Pregabalin; Drug: Tramadol; Drug: Dexamethasone; Drug: Acetaminophen; Drug: Ropivicaine; Drug: Epinephrine; Drug: Ketorolac; Drug: Tizanidine; Drug: Magnesium; Drug: Ibuprofen

Multimodal Plus Narcotic

ACTIVE COMPARATOR

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.

Drug: Celecoxib; Drug: Pregabalin; Drug: Tramadol; Drug: Dexamethasone; Drug: Acetaminophen; Drug: Ropivicaine; Drug: Epinephrine; Drug: Ketorolac; Drug: Tizanidine; Drug: Magnesium; Drug: Ibuprofen; Drug: Oxycodone Hydrochloride 5 Mg

Interventions

Celecoxib DRUG

preoperative pain medication given to all patients

Also known as: Celebrex

Multimodal Plus Narcotic; Multimodal, Non-Narcotic

Pregabalin DRUG

preoperative and discharge pain medication given to all patients

Also known as: Lyrica

Multimodal Plus Narcotic; Multimodal, Non-Narcotic

Tramadol DRUG

preoperative pain medication given to all patients

Also known as: Ultram

Multimodal Plus Narcotic; Multimodal, Non-Narcotic

Dexamethasone DRUG

Intraoperative and discharge pain medication given to all patients

Also known as: Decadron

Multimodal Plus Narcotic; Multimodal, Non-Narcotic

Acetaminophen DRUG

Intraoperative and discharge pain medication given to all patients

Also known as: tylenol

Multimodal Plus Narcotic; Multimodal, Non-Narcotic

Ropivicaine DRUG

Intraoperative pain medication given to all patients

Also known as: naropin

Multimodal Plus Narcotic; Multimodal, Non-Narcotic

Epinephrine DRUG

Intraoperative pain medication given to all patients

Multimodal Plus Narcotic; Multimodal, Non-Narcotic

Ketorolac DRUG

Intraoperative pain medication given to all patients

Multimodal Plus Narcotic; Multimodal, Non-Narcotic

Tizanidine DRUG

Discharge pain medication given to all patients

Also known as: Zanaflex

Multimodal Plus Narcotic; Multimodal, Non-Narcotic

Magnesium DRUG

Discharge pain medication given to all patients

Also known as: magnesium oxide

Multimodal Plus Narcotic; Multimodal, Non-Narcotic

Ibuprofen DRUG

Discharge pain medication given to all patients

Also known as: Motrin

Multimodal Plus Narcotic; Multimodal, Non-Narcotic

Oxycodone Hydrochloride 5 Mg DRUG

Only given to active comparator group

Also known as: Roxicodone

Multimodal Plus Narcotic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consented and scheduled for primary anatomic or reverse total shoulder arthroplasty at a Henry Ford hospital location

You may not qualify if:

• Unable to receive or reply to mobile phone text messages.
• Unable to read or speak English
• Medical history of known allergies or intolerance to any of the medications prescribed as a part of this study (ie, Percocet, Ibuprofen, Pregabalin, Dexamethasone, Acetaminophen, Tizanidine, Magnesium, Celecoxib, Tramadol, Ropivacaine, Epinephrine, Ketorolac)
• Substantial alcohol or drug abuse
• Recent or current pregnancy
• History of narcotic use within 3 months prior to surgery
• Renal or hepatic impairment or dysfunction
• Use of blood thinner medication
• Peptic ulcer disease
• Gastrointestinal bleeding
• History of gastric bypass surgery

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Health

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Shoulder Pain

Interventions

Celecoxib; Pregabalin; Tramadol; Dexamethasone; Calcium Dobesilate; Acetaminophen; Ropivacaine; Epinephrine; Ketorolac; tizanidine; Magnesium; Magnesium Oxide; Ibuprofen; Oxycodone

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Amino Acids; Amino Acids, Peptides, and Proteins; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Dimethylamines; Methylamines; Amines; Lipids; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Acetanilides; Anilides; Aniline Compounds; Ethanolamines; Amino Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals, Light; Metals; Magnesium Compounds; Oxides; Oxygen Compounds; Phenylpropionates; Acids, Carbocyclic; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Phenanthrenes; Polycyclic Aromatic Hydrocarbons

Results Point of Contact

• Title: Stephanie Muh M.D.
• Organization: Henry Ford Health

smuh1@hfhs.org

3135873854

Study Officials

• Stephanie J Muh, MD

  Henry Ford Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief, Department of Orthopaedics Surgery Service

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: August 5, 2022
• Study Start: June 25, 2022
• Primary Completion: December 11, 2024
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 10, 2026
• Results First Posted: February 10, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)