Postoperative Pain Control in Total Shoulder Arthroplasty

NCT ID: NCT05068960

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2025-02-01

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.

Conditions

Total Shoulder Arthroplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Study group

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

Group Type: EXPERIMENTAL

Liposomal bupivacaine

Intervention Type: DRUG

Addition of liposomal bupivacaine to the interscalene block for extended pain control following total shoulder arthroplasty

Bupivacaine

Intervention Type: DRUG

Interscalene block with bupivacaine for pain control following total shoulder arthroplasty

Control group

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

Group Type: ACTIVE_COMPARATOR

Bupivacaine

Intervention Type: DRUG

Interscalene block with bupivacaine for pain control following total shoulder arthroplasty

Interventions

Liposomal bupivacaine

Addition of liposomal bupivacaine to the interscalene block for extended pain control following total shoulder arthroplasty

Intervention Type: DRUG

Bupivacaine

Interscalene block with bupivacaine for pain control following total shoulder arthroplasty

Intervention Type: DRUG

Other Intervention Names

Exparel; Marcaine

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
• Comorbidity that is contraindicated with the administration of an interscalene block
• Cognitive or mental health status that interferes with study

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Scripps Clinic

OTHER

Sponsor Role: lead

Responsible Party

Heinz Hoenecke, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heinz Hoenecke, MD

Role: PRINCIPAL_INVESTIGATOR

Scripps Health

Locations

Scripps Clinic

La Jolla, California, United States

Countries

United States

Other Identifiers

IRB-19-7479

Identifier Type: -

Identifier Source: org_study_id