Opioid-Free Pain Protocol After Shoulder Arthroplasty

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: Recruiting
• Conditions: Shoulder Pain; Shoulder Arthropathy
• Intervention / Treatment: 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

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: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Johnny Kasto, MD; Phone Number: 313-244-8078; Email: jkasto1@hfhs.org
• Study Contact Backup: Name: Stephanie J Muh, MD

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Henry Ford Health
      • Contact: Johnny Kasto; Phone Number: 313-244-8078; Email: jkasto1@hfhs.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Pain levels	Patients record pain levels using Visual analog scales for 10 days post-operatively. 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-Reported Outcomes scores (PROMs) for upper extremity pain interference	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.	The first 10 days postoperatively
Patient-Reported Outcomes scores (PROMs) for upper extremity function	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.	The first 10 days postoperatively
Patient-Reported Outcomes scores (PROMs) for depression	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).	The first 10 days postoperatively
Complications	Both intra- and postoperative complications will be collected.	Intraoperative to 2 years postoperative
Reoperation	Whether or not patients required another operation.	To 2 years postoperative
Shoulder Range of Motion	Standard range of motion values collected by the surgeon during preoperative and follow-up visits.	Preoperatively to 2 years postoperative
Shoulder Strength	Standard shoulder strength values collected by the surgeon during preoperative and follow-up visits. Medical Research Council Manual Muscle Testing scale will be used to measure the patient's strength on a 0 to 5 scale with 0 being the minimum and 5 being the maximum. Higher scores are better/normal.	Preoperatively to 2 years postoperative
Morphine milligram equivalents	The morphine milligram equivalents (MMEs) of opioids consumed will be recorded.	The first 10 days postoperatively.

Collaborators and Investigators

• Sponsor: Henry Ford Health System
• Investigators: Principal Investigator: Stephanie J Muh, MD, Henry Ford Health

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: July 20, 2022
• First Submitted That Met QC Criteria: August 3, 2022
• First Posted (Actual): August 5, 2022

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Calcium-Regulating Hormones and Agents; Cyclooxygenase 2 Inhibitors; Calcium Channel Blockers; Neuromuscular Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Muscle Relaxants, Central; Mydriatics; Antacids; Dexamethasone; Ketorolac; Celecoxib; Acetaminophen; Pregabalin; Ibuprofen; Tramadol; Epinephrine; Oxycodone; Magnesium Oxide; Tizanidine
• Other Study ID 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