Postoperative Pain Control in Total Shoulder Arthroplasty

Scripps Clinic

Status and phase: Completed; Phase 4

Conditions: Total Shoulder Arthroplasty

Treatments: Drug: Liposomal bupivacaine; Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT05068960

IRB-19-7479

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

Study group

Experimental group

Description:

The study group will receive an interscalene block consisting of 10 mL 0.5% bupivacaine and 10 mL of liposomal bupivacaine \[133mg\].

Treatment:

Drug: Bupivacaine

Drug: Liposomal bupivacaine

Control group

Active Comparator group

Description:

The control group will receive an interscalene block consisting of 20 mL of 0.5%bupivacaine alone.

Treatment:

Drug: Bupivacaine