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
Overview
- Phase
- Phase 4
- Intervention
- Liposomal bupivacaine
- Conditions
- Total Shoulder Arthroplasty
- Sponsor
- Scripps Clinic
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Narcotic usage
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
In order to reduce narcotic abuse potential, orthopaedic surgeons have explored multimodal pain regimens in addition to regional anesthesia to improve postoperative pain control. One commonly used intervention to reduce postoperative shoulder pain has been the interscalene brachial plexus block. This block provides significant pain relief for shoulder procedures, but has been limited to less than 24 hours even with long acting anesthetics. In the setting of shoulder arthroplasty, this short-term pain control often leads to the need for increased narcotic pain medication. Since shoulder arthroplasty has been steadily increasing in the United States with an annual growth rate of 10.6%, it is imperative to control patients' postoperative pain without increasing their risk for opiate abuse. A potential method for achieving this is by using liposomal bupivacaine in the interscalene blocks. This study is a double blind, prospective, randomized trial to evaluate the postoperative pain profiles among shoulder arthroplasty patients receiving interscalene block with and without the addition of liposomal bupivacaine. The purpose of this study is to determine if patients undergoing shoulder arthroplasty with an interscalene brachial plexus block with liposomal bupivacaine (study group) or without liposomal bupivacaine (control group) will have differences in postoperative opiate consumption, patient-reported pain, satisfaction with surgery, and shoulder function.
Investigators
Heinz Hoenecke, MD
Principal Investigator
Scripps Clinic
Eligibility Criteria
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
Arms & Interventions
Study group
The study group will receive an interscalene block consisting of 10 mL 0.5% bupivacaine and 10 mL of liposomal bupivacaine \[133mg\].
Intervention: Liposomal bupivacaine
Study group
The study group will receive an interscalene block consisting of 10 mL 0.5% bupivacaine and 10 mL of liposomal bupivacaine \[133mg\].
Intervention: Bupivacaine
Control group
The control group will receive an interscalene block consisting of 20 mL of 0.5%bupivacaine alone.
Intervention: Bupivacaine
Outcomes
Primary Outcomes
Narcotic usage
Time Frame: Postoperatively (up to 1 week)
Number and type of narcotic pain pills consumed during the first postoperative week (also converted into morphine equivalents)
Secondary Outcomes
- Severity of pain and its impact on functioning (Brief Pain Inventory - Short Form modified)(Postoperatively (at 1 week))
- Pain score (Numeric Rating Scale): Preoperatively, postoperatively, and change from preoperatively to postoperatively(Preoperatively (up to 30 days before surgery) and postoperatively (at 4 weeks), and change from preoperatively to postoperatively)
- Satisfaction with the results of surgery (Self-Administered Patient Satisfaction Scale)(Postoperatively (at 4 weeks))
- American Shoulder and Elbow Surgeons (ASES) score: preoperatively, postoperatively, and change from preoperatively to postoperatively(Preoperatively (up to 30 days before surgery) and postoperatively (at 4 weeks), and change from preoperatively to postoperatively)
- Non narcotic pain medication usage(Postoperatively (up to 1 week))