Shoulder Pain Clinical Trial
Official title:
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Henry Ford Health | Detroit | Michigan |
Lead Sponsor | Collaborator |
---|---|
Henry Ford Health System |
United States,
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. |
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