Opioid-Free Pain Protocol After Shoulder Arthroplasty

NCT ID: NCT05488847

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-25
• Study Completion Date: 2026-09-01

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.

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.

Conditions

Shoulder Arthropathy; Shoulder Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Celecoxib

Intervention Type: DRUG

preoperative pain medication given to all patients

Pregabalin

Intervention Type: DRUG

preoperative and discharge pain medication given to all patients

Tramadol

Intervention Type: DRUG

preoperative pain medication given to all patients

Dexamethasone

Intervention Type: DRUG

Intraoperative and discharge pain medication given to all patients

Acetaminophen

Intervention Type: DRUG

Intraoperative and discharge pain medication given to all patients

Ropivicaine

Intervention Type: DRUG

Intraoperative pain medication given to all patients

Epinephrine

Intervention Type: DRUG

Intraoperative pain medication given to all patients

Ketorolac

Intervention Type: DRUG

Intraoperative pain medication given to all patients

Tizanidine

Intervention Type: DRUG

Discharge pain medication given to all patients

Magnesium

Intervention Type: DRUG

Discharge pain medication given to all patients

Ibuprofen

Intervention Type: DRUG

Discharge pain medication given to all patients

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.

Group Type: ACTIVE_COMPARATOR

Celecoxib

Intervention Type: DRUG

preoperative pain medication given to all patients

Pregabalin

Intervention Type: DRUG

preoperative and discharge pain medication given to all patients

Tramadol

Intervention Type: DRUG

preoperative pain medication given to all patients

Dexamethasone

Intervention Type: DRUG

Intraoperative and discharge pain medication given to all patients

Acetaminophen

Intervention Type: DRUG

Intraoperative and discharge pain medication given to all patients

Ropivicaine

Intervention Type: DRUG

Intraoperative pain medication given to all patients

Epinephrine

Intervention Type: DRUG

Intraoperative pain medication given to all patients

Ketorolac

Intervention Type: DRUG

Intraoperative pain medication given to all patients

Tizanidine

Intervention Type: DRUG

Discharge pain medication given to all patients

Magnesium

Intervention Type: DRUG

Discharge pain medication given to all patients

Ibuprofen

Intervention Type: DRUG

Discharge pain medication given to all patients

Oxycodone Hydrochloride 5 Mg

Intervention Type: DRUG

Only given to active comparator group

Interventions

Celecoxib

preoperative pain medication given to all patients

Intervention Type: DRUG

Pregabalin

preoperative and discharge pain medication given to all patients

Intervention Type: DRUG

Tramadol

preoperative pain medication given to all patients

Intervention Type: DRUG

Dexamethasone

Intraoperative and discharge pain medication given to all patients

Intervention Type: DRUG

Acetaminophen

Intraoperative and discharge pain medication given to all patients

Intervention Type: DRUG

Ropivicaine

Intraoperative pain medication given to all patients

Intervention Type: DRUG

Epinephrine

Intraoperative pain medication given to all patients

Intervention Type: DRUG

Ketorolac

Intraoperative pain medication given to all patients

Intervention Type: DRUG

Tizanidine

Discharge pain medication given to all patients

Intervention Type: DRUG

Magnesium

Discharge pain medication given to all patients

Intervention Type: DRUG

Ibuprofen

Discharge pain medication given to all patients

Intervention Type: DRUG

Oxycodone Hydrochloride 5 Mg

Only given to active comparator group

Intervention Type: DRUG

Other Intervention Names

Celebrex; Lyrica; Ultram; Decadron; tylenol; naropin; Zanaflex; magnesium oxide; Motrin; Roxicodone

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Henry Ford Health System

OTHER

Sponsor Role: lead

Responsible Party

Stephanie Muh, MD

Deputy Chief, Department of Orthopaedics Surgery Service

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephanie J Muh, MD

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Health

Locations

Henry Ford Health

Detroit, Michigan, United States

Countries

United States

Other Identifiers

15592

Identifier Type: -

Identifier Source: org_study_id