Total Shoulder Arthroplasty Clinical Trial
Official title:
A Prospective Randomized Controlled Trial to Evaluate the Efficacy of an Interscalene Brachial Plexus Block and Multimodal Analgesia With and Without Liposomal Bupivacaine for Postoperative Pain Control in Total Shoulder Arthroplasty
A double blind, prospective, randomized trial to evaluate postoperative pain, narcotic use, patient satisfaction, and function among shoulder arthroplasty patients receiving interscalene block with and without the addition of liposomal bupivacaine.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | July 1, 2025 |
Est. primary completion date | March 1, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years to 85 Years |
Eligibility | Inclusion Criteria: • Patients undergoing primary shoulder arthroplasty or reverse shoulder arthroplasty Exclusion Criteria: - Patients under the age of 50 years - Patients over the age of 85 - Patients undergoing a revision shoulder procedure - Documented drug or alcohol abuse - Active narcotic use within 3 months prior to surgery - Neurological deficit - Allergy to amide anesthetics - Oxycodone intolerance - Unable to take Celebrex - Enrollment in another clinical trial - Comorbidity that is contraindicated with the administration of an interscalene block - Cognitive or mental health status that interferes with study |
Country | Name | City | State |
---|---|---|---|
United States | Scripps Clinic | La Jolla | California |
Lead Sponsor | Collaborator |
---|---|
Scripps Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Narcotic usage | Number and type of narcotic pain pills consumed during the first postoperative week (also converted into morphine equivalents) | Postoperatively (up to 1 week) | |
Secondary | Severity of pain and its impact on functioning (Brief Pain Inventory - Short Form modified) | Patients' self-reported pain severity and impact on functioning as measured on the Brief Pain Inventory Short-Form modified survey | Postoperatively (at 1 week) | |
Secondary | Pain score (Numeric Rating Scale): Preoperatively, postoperatively, and change from preoperatively to postoperatively | Patients' self-reported pain as measured on the Numeric Rating Scale | Preoperatively (up to 30 days before surgery) and postoperatively (at 4 weeks), and change from preoperatively to postoperatively | |
Secondary | American Shoulder and Elbow Surgeons (ASES) score: preoperatively, postoperatively, and change from preoperatively to postoperatively | The ASES score is a 100-point scale that evaluates two dimensions of shoulder function: pain and performance in activities of daily living. Each of the two domains make up for 50 of the 100 points. A score of 0 indicates the worst shoulder condition and a score of 100 indicates the best shoulder condition. | Preoperatively (up to 30 days before surgery) and postoperatively (at 4 weeks), and change from preoperatively to postoperatively | |
Secondary | Satisfaction with the results of surgery (Self-Administered Patient Satisfaction Scale) | Patients' satisfaction with results of surgery as measured on the Self-Administered Patient Satisfaction Scale | Postoperatively (at 4 weeks) | |
Secondary | Non narcotic pain medication usage | Number and type of non-narcotic pain pills consumed during the first postoperative week | Postoperatively (up to 1 week) |
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