NCT05488847

Opioid-Free Pain Protocol After Shoulder Arthroplasty

Multimodal Nonopioid Pain Protocol Following Shoulder Arthroplasty Surgery

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Celecoxib	preoperative pain medication given to all patients
DRUG	Pregabalin	preoperative and discharge pain medication given to all patients
DRUG	Tramadol	preoperative pain medication given to all patients
DRUG	Dexamethasone	Intraoperative and discharge pain medication given to all patients
DRUG	Acetaminophen	Intraoperative and discharge pain medication given to all patients
DRUG	Ropivicaine	Intraoperative pain medication given to all patients
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
DRUG	Magnesium	Discharge pain medication given to all patients
DRUG	Ibuprofen	Discharge pain medication given to all patients
DRUG	Oxycodone Hydrochloride 5 Mg	Only given to active comparator group

Timeline

• Start date: 2022-06-25
• Primary completion: 2024-12-11
• Completion: 2026-09-01
• First posted: 2022-08-05
• Last updated: 2026-02-10
• Results posted: 2026-02-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study