Opioid-Free Pain Protocol After Shoulder Arthroplasty

January 24, 2026 updated by: Stephanie Muh, MD, Henry Ford Health System

Multimodal Nonopioid Pain Protocol Following Shoulder Arthroplasty Surgery

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The United States is in the midst of an ongoing opioid crisis. In 2019, approximately 153 million opioid prescriptions were dispensed (46.7 per 100 persons) and 50,000 people died from opioid-involved overdoses. Orthopaedic and spine conditions account for 27.7% of opioid prescriptions and prior studies demonstrate that musculoskeletal pain is frequently reported by opioid abusers as their initial reason for consuming opioids. For these reasons, orthopaedic surgeons are uniquely posed to combat this crisis. Multimodal pain control is a strategy that utilizes multiple pain medications to provide analgesia. The theory behind this strategy is that agents with different mechanisms of action work synergistically to reduce pain by blocking multiple pain pathways. Several randomized controlled trials have investigated the efficacy of multimodal pain control for orthopaedic procedures, including anterior cruciate ligament reconstruction, labral repair, meniscus repair, and rotator cuff repair. In these studies, patients who received a multimodal nonopioid regimen had equivalent or better postoperative pain control compared to a standard opioid regimen. Furthermore, no severe side effects were reported in patients who received the multimodal nonopioid regimen. This randomized, single blinded, standard of care-controlled clinical trial aims to investigate the efficacy of a multimodal pain control (similar to the regimen utilized in the aforementioned studies) for controlling pain following shoulder arthroplasty. Adult patients indicated for anatomic or reverse total shoulder arthroplasty will be randomized to either the experimental or comparison group. The experimental group will receive a multimodal, non-narcotic pain control regimen consisting of Celecoxib, Pregabalin, and Tramadol preoperatively; Dexamethasone, Acetaminophen, Ropivacaine, Epinephrine, and Ketorolac intraoperatively; and Dexamethasone, Pregabalin, Tizanidine, Magnesium, Ibuprofen, and Acetaminophen postoperatively. In addition to the aforementioned multimodal pain control regimen, the comparison group will receive a standard prescription of Oxycodone to be taken as needed postoperatively. If patients in the experimental group feel their pain is uncontrolled, they have the option of calling in to request a prescription of Oxycodone. Pain, pain medication use, and medication side effects will be closely monitored for the first 10 days after surgery by having patients respond to daily automated text messages. Additionally, all study participants will complete patient-reported outcome measures (PROMs) surveys and undergo physical examination of their shoulder during routine clinic visits preoperatively and at 1 week, 6 weeks, 3 months, 6 months, 1 year, and 2 years postoperatively. The primary outcome of this study is postoperative pain scores on the Numerical Rating Scale (NRS) for the first 10 days postoperatively. We hypothesize that there will be no significant difference between the groups with regard to the primary outcome. Secondary outcomes measured during the first 10 days postoperative include morphine milligram equivalents (MMEs) of opioids consumed, Patient-Reported Outcome Measurement Information System Pain Interference (PROMIS-PI) score at first postoperative clinic visit (7-10 days postoperatively), duration of patient reported adverse events (ie, constipation, nausea, diarrhea, upset stomach, drowsiness, loopiness), perioperative complications, and satisfaction with pain control. Secondary outcomes measured at routine postoperative clinic visits out to 2 years after surgery include postoperative complications, need for revision surgery, PROM scores (ie, PROMIS upper extremity, PROMIS PI, PROMIS D, American Shoulder and Elbow Surgeons Shoulder Score, Shoulder Arthroplasty Smart, Constant-Murley), hospital and emergency department readmission (30-day, 60-day, 90-day), duration of narcotic pain medication use shoulder strength, and shoulder range of motion.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
83

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Stephanie J Muh, MD

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Multimodal, Non-Narcotic
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
preoperative pain medication given to all patients
Other Names:
  • Celebrex
Drug: Pregabalin
preoperative and discharge pain medication given to all patients
Other Names:
  • Lyrica
Drug: Tramadol
preoperative pain medication given to all patients
Other Names:
  • Ultram
Drug: Dexamethasone
Intraoperative and discharge pain medication given to all patients
Other Names:
  • Decadron
Drug: Acetaminophen
Intraoperative and discharge pain medication given to all patients
Other Names:
  • tylenol
Drug: Ropivicaine
Intraoperative pain medication given to all patients
Other Names:
  • naropin
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
Other Names:
  • Zanaflex
Drug: Magnesium
Discharge pain medication given to all patients
Other Names:
  • magnesium oxide
Drug: Ibuprofen
Discharge pain medication given to all patients
Other Names:
  • Motrin
Active Comparator: Multimodal Plus Narcotic
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
preoperative pain medication given to all patients
Other Names:
  • Celebrex
Drug: Pregabalin
preoperative and discharge pain medication given to all patients
Other Names:
  • Lyrica
Drug: Tramadol
preoperative pain medication given to all patients
Other Names:
  • Ultram
Drug: Dexamethasone
Intraoperative and discharge pain medication given to all patients
Other Names:
  • Decadron
Drug: Acetaminophen
Intraoperative and discharge pain medication given to all patients
Other Names:
  • tylenol
Drug: Ropivicaine
Intraoperative pain medication given to all patients
Other Names:
  • naropin
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
Other Names:
  • Zanaflex
Drug: Magnesium
Discharge pain medication given to all patients
Other Names:
  • magnesium oxide
Drug: Ibuprofen
Discharge pain medication given to all patients
Other Names:
  • Motrin
Drug: Oxycodone Hydrochloride 5 Mg
Only given to active comparator group
Other Names:
  • Roxicodone

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain Levels
Time Frame: The first 10 days postoperatively
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
Time Frame: The first 10 days postoperatively.
The morphine milligram equivalents (MMEs) of opioids consumed will be recorded.
The first 10 days postoperatively.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient-Reported Outcomes Scores (PROMs) for Upper Extremity Pain Interference
Time Frame: Preoperatively, 10 days postoperatively, 6 weeks postoperatively, and 3 months postoperatively
Patient-Reported Outcome Measures (PROMs) scores for upper extremity pain and how it interferes with the patients daily life. A T-score is given with a standard deviation based on the patients answers to the computerized adaptive test. The metrics have been designed to conform to a 10 - 90-point scale, with a score of 50 representing the mean of the population at large, 10 representing the minimum, and 90 representing the maximum function. A higher T-score represents higher pain interference (worse outcomes). Patient-Reported Outcomes Measurement Information System Physical Interference (PROMIS-PI) once every night for 10 days post-operatively.
Preoperatively, 10 days postoperatively, 6 weeks postoperatively, and 3 months postoperatively
Patient-Reported Outcomes Scores (PROMs) for Upper Extremity Function
Time Frame: Preoperatively, 6 weeks postoperatively, and 3 months postoperatively
Patient-Reported Outcome Measures (PROMs) scores for upper extremity function. A T-score is given with a standard deviation based on the patients answers to the computerized adaptive test. The metrics have been designed to conform to a 0 - 100-point scale, with a score of 50 representing the mean of the population at large, 0 representing the minimum, and 100 representing the maximum function.
Preoperatively, 6 weeks postoperatively, and 3 months postoperatively
Patient-Reported Outcomes Scores (PROMs) for Depression
Time Frame: Preoperatively, 6 weeks postoperatively, and 3 months postoperatively
Patient-Reported Outcome Measures (PROMs) scores for depression. A T-score is given with a standard deviation based on the patients answers to the computerized adaptive test. The metrics have been designed to conform to a 10 - 90-point scale, with a score of 50 representing the mean of the population at large, 10 representing the minimum, and 90 representing the maximum function. A higher T-score represents higher increased depression (worse).
Preoperatively, 6 weeks postoperatively, and 3 months postoperatively
American Shoulder and Elbow Score
Time Frame: Preoperatively, 6 weeks postoperatively, and 3 months postoperatively
This is a patient reported outcome measure meant to assess participant shoulder function and pain. The score ranges from 0 to 100, with 0 representing a combination of poor shoulder function and high pain burden and 100 representing a lack of shoulder pain or functional deficit. The score is obtained by combining two subscale scores which are weighted equally. The first subscale is the visual analog scale, which asks participants to rate their pain on a scale of 0 to 10. A score of 0 indicates no pain and a score of 10 indicates the worst pain imaginable. The second subscale is the activities of daily living questionnaire. This questionnaire is composed of 10 questions, each asking about a specific activity of daily living related to shoulder function. For each question, the answer choices include: unable to do (0 points); very difficult to do (1 point); somewhat difficult (2 points); not difficult (3 points).
Preoperatively, 6 weeks postoperatively, and 3 months postoperatively
Shoulder Arthroplasty Smart Score (SAS)
Time Frame: preoperatively; 6 weeks postoperatively; 3 months postoperatively
This is a score from 0 to 100 meant to represent the level of participant shoulder function. 0 represents the most poor function, and 100 the best possible score for function. The score is determined by combining three range of motion measures and 3 questions which are answered on a scale of 0 to 10. The three range of motion measures include forward flexion, internal rotation, and external rotation. The remaining three questions are as follows: What is your average pain on a daily basis?; What is your ability to use your affected shoulder on a daily basis?; What is your average pain when lying on affected side?
preoperatively; 6 weeks postoperatively; 3 months postoperatively
Medication Side Effects
Time Frame: First 10 days postoperatively
The side effects were assessed to see whether they were present or not in the first 10 days postoperatively. They include constipation, nausea, diarrhea, upset stomach drowsiness, and loopiness
First 10 days postoperatively
Number of Patients Who Required Reoperation
Time Frame: To 2 years postoperative
Whether or not patients required another operation.
To 2 years postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Henry Ford Health System

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stephanie J Muh, MD, Henry Ford Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 25, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 11, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 20, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 15592

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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