Opioid-Free Pain Protocol After Shoulder Arthroplasty

Shoulder Pain Clinical Trial

Official title:

Multimodal Nonopioid Pain Protocol Following Shoulder Arthroplasty Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05488847
• Other study ID #: 15592
• Status: Recruiting
• Phase: Phase 4
• Start date: June 25, 2022
• Est. completion date: December 1, 2025

Study information

• Verified date: January 2024
• Source: Henry Ford Health System
• Contact: Johnny Kasto, MD
• Phone: 313-244-8078
• Email: jkasto1[@]hfhs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Arthropathy
• Shoulder Pain

Intervention

Drug:
• Celecoxib
preoperative pain medication given to all patients
• Pregabalin
preoperative and discharge pain medication given to all patients
• Tramadol
preoperative pain medication given to all patients
• Dexamethasone
Intraoperative and discharge pain medication given to all patients
• Acetaminophen
Intraoperative and discharge pain medication given to all patients
• Ropivicaine
Intraoperative pain medication given to all patients
• Epinephrine
Intraoperative pain medication given to all patients
• Ketorolac
Intraoperative pain medication given to all patients
• Tizanidine
Discharge pain medication given to all patients
• Magnesium
Discharge pain medication given to all patients
• Ibuprofen
Discharge pain medication given to all patients
• Oxycodone Hydrochloride 5 Mg
Only given to active comparator group

Locations

Country	Name	City	State
United States	Henry Ford Health	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Complications	Both intra- and postoperative complications will be collected.	Intraoperative to 2 years postoperative
Secondary	Reoperation	Whether or not patients required another operation.	To 2 years postoperative
Secondary	Shoulder Range of Motion	Standard range of motion values collected by the surgeon during preoperative and follow-up visits.	Preoperatively to 2 years postoperative
Secondary	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
Secondary	Morphine milligram equivalents	The morphine milligram equivalents (MMEs) of opioids consumed will be recorded.	The first 10 days postoperatively.