Postoperative Pain Control in Total Shoulder Arthroplasty

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.

Study Overview

• Status: Completed
• Conditions: Total Shoulder Arthroplasty
• Intervention / Treatment: Drug: Liposomal bupivacaine; Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Scripps Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group; The study group will receive an interscalene block consisting of 10 mL 0.5% bupivacaine and 10 mL of liposomal bupivacaine [133mg].	Drug: Liposomal bupivacaine; Addition of liposomal bupivacaine to the interscalene block for extended pain control following total shoulder arthroplasty; Other Names: Exparel; Drug: Bupivacaine; Interscalene block with bupivacaine for pain control following total shoulder arthroplasty; Other Names: Marcaine
Active Comparator: Control group; The control group will receive an interscalene block consisting of 20 mL of 0.5%bupivacaine alone.	Drug: Bupivacaine; Interscalene block with bupivacaine for pain control following total shoulder arthroplasty; Other Names: Marcaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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
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
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)
Non narcotic pain medication usage	Number and type of non-narcotic pain pills consumed during the first postoperative week	Postoperatively (up to 1 week)

Collaborators and Investigators

• Sponsor: Scripps Clinic
• Investigators: Principal Investigator: Heinz Hoenecke, MD, Scripps Health

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): February 1, 2025
• Study Completion (Actual): February 1, 2025

Study Registration Dates

• First Submitted: July 21, 2021
• First Submitted That Met QC Criteria: September 30, 2021
• First Posted (Actual): October 6, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 18, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Bupivacaine
• Other Study ID Numbers: IRB-19-7479

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes