Effects on Postoperative Pain of Liposomal Bupivacaine in Interscalene Blocks for Total Shoulder Arthroplasty Patients

April 23, 2026 updated by: Johnny K. Lee

A Double-Blind Randomized Comparison Trial of Postoperative Pain in Patients Undergoing Total Shoulder Arthroplasty Who Receive Interscalene Blocks With or Without Liposomal Bupivacaine (PoPTSAWoW Trial)

The purpose of this trial is to compare the difference in the proportion of patients with tolerable pain scores, VAS pain scores, quality of recovery and opioid use in milligram equivalents (at 24, 48, 72, 96 and 120 hours postoperatively) in patients undergoing shoulder arthroplasty who receive interscalene blocks with or without Liposomal Bupivacaine.

This is a prospective randomized, double-blinded, controlled trial that will enroll 130 subjects undergoing total shoulder arthroplasty or reverse total shoulder arthroplasty. Participants who meet all eligibility criteria will be randomized in a 1:1 ratio to receive either 36 mL of 0.5% bupivacaine (PB group) or 10 mL of liposomal bupivacaine and 20 mL of 0.25 % bupivacaine and 6 mL of saline (LB group).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Patients undergoing shoulder surgery can suffer from significant postoperative pain which can lead to an increase in recovery time, opioid use and potential dependency, and a decrease in quality of recovery. The interscalene brachial plexus block is a common effective regional anesthesia technique used for a variety of procedures involving the shoulder. The number of total shoulder arthroplasty surgeries being performed annually in the United States are increasing every year. Liposomal bupivacaine was FDA approved for use in patients undergoing interscalene block in 2018 to reduce postoperative pain from shoulder surgery. The information from the manufacturer indicates that the liposomal encapsulation may release the drug for up to approximately 72 hours after it has been administered, providing a prolonged analgesic effect. Evidence to the prolonged analgesic effect of liposomal bupivacaine has varied in the current literature. A recent meta-analysis suggested that liposomal bupivacaine may provide a statistically significant, but clinically insignificant decrease in opioid consumption and pain scores over time. The authors noted a possible limitation of their study is that the meta-analysis included a variety of surgical procedures and block techniques, and was not specific to shoulder surgery or interscalene block. The authors noted that this variability in anesthetic regimens between study groups could have affected the observed outcomes.

Recently, the investigators performed a retrospective quality improvement study to investigate the potential benefit of liposomal bupivacaine used for interscalene blocks among 491 patients undergoing shoulder arthroplasty between 2018 and 2021. The investigators compared the difference in the proportion of patients with clinically tolerable pain scores (defined as VAS ≤ 4) in those patients receiving liposomal bupivacaine vs. those receiving another local anesthetic (plain bupivacaine, mepivacaine or ropivacaine) vs. those receiving no block. The results of this study suggested there was significant difference in the proportion of patients with clinically tolerable pain scores when receiving liposomal bupivacaine during all observations and at 3 days postoperatively versus those patient that did not. The patients who received liposomal bupivacaine also had a significant reduction in morphine milligram equivalents (MMEs).

Based on the investigators retrospective results, the investigators performed a power analysis which allowed for the development of this prospective randomized double blinded trial comparing liposomal bupivacaine plus plain bupivacaine vs. plain bupivacaine only in near equipotent doses. The investigators believe that this is a very important and unique trial to perform as it could change the way pain management is delivered in this patient population. Longer acting local anesthetic used for interscalene blocks may increase the number of patients who have tolerable pain and require less or no opioids. This could reduce or inevitably eliminate the unwanted effects of opioids (nausea, vomiting, constipation, urinary retention, opioid induced respiratory depression, dependency and addiction) and result in an improvement in the quality of recovery of patients undergoing total shoulder arthroplasties.

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Skokie, Illinois, United States, 60076
        • Northshore University Healthsystem

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Subject ages 18-90 years old
  • Male or Female subjects
  • Weight ≥ 60 kg.
  • Must be able to consent in English

Exclusion Criteria:

  • Ages: <18 and >90
  • Weight < 60 kg
  • Multiple surgeries during one hospital stay
  • Emergency surgery
  • Allergy or any contraindication to local anesthetics used in trial.
  • Pregnancy
  • Contraindicated for use of liposomal bupivacaine
  • Severe liver/kidney disease
  • Defined as a diagnosis of end-stage renal disease (ESRD) defined as being on dialysis
  • Subject who received another local anesthetic block prior to the interscalene block.
  • Unable to consent in English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Liposomal Bupivacaine Group
10 mL (133 mg) Liposomal bupivacaine and 20 mL (50 mg) 0.25% bupivacaine and 6 mL of saline (183 mg)
Drug: Liposomal bupivacaine
Subjects randomized to the Liposomal bupivacaine group will receive 10 mL (133 mg) of Liposomal bupivacaine and 20 mL (50 mg) of 0.25% bupivacaine and 6 mL of saline (183 mg).
Other Names:
  • Exparel
Other: Plain Bupivacaine Group
36 mL (180 mg) 0.5% bupivacaine
Drug: Bupivacaine
Subjects randomized to the Plain Bupivacaine group will receive 36 mL (180 mg) of 0.5% bupivacaine.
Other Names:
  • Marcaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The difference in the proportion of patients with clinically significant tolerable pain scores
Time Frame: at Post-operative Day 1
The investigators will collect the difference in the proportion of patients with clinically significant tolerable pain scores (defined as Visual Analogue Scale (VAS) ≤ 4) post-op Day One in those patients receiving an interscalene block with liposomal bupivacaine with plain bupivacaine vs. plain bupivacaine. Subjects will rate their pain level on a scale of 0-10. Number "0" indicates no pain and number "10" indicates terrible pain.
at Post-operative Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The difference in Visual Analogue Scale (VAS) pain scores (0 - 10)
Time Frame: Upon Post Anesthesia Care Unit (PACU) admission; Day 0; Post-operative Day 1, Day 2, Day 3, Day 4, and Day 5.
The investigators will collect the difference in VAS pain scores (0 - 10) in each group. Subjects will rate their pain level on a scale of 0-10. Number "0" indicates no pain and number "10" indicates terrible pain.
Upon Post Anesthesia Care Unit (PACU) admission; Day 0; Post-operative Day 1, Day 2, Day 3, Day 4, and Day 5.
The difference in quality of recovery survey-15 responses
Time Frame: on Post-operative Day 1, Day 2, Day 3, Day 4 and Day 5.
The investigators will collect the difference in quality of recovery survey-15 responses in each group. QoR15 survey has a scale of 0-10. Number "0" indicates none of the time and number "10" indicates all of the time.
on Post-operative Day 1, Day 2, Day 3, Day 4 and Day 5.
Opioid use in morphine milligram equivalents (MME)
Time Frame: on day of surgery; on Post-operative Day 1, Day 2, Day 3, Day 4, and Day 5
The investigators will collect opioid use in morphine milligram equivalents data from the patients electronic medical record and via an electronic survey sent to patients.
on day of surgery; on Post-operative Day 1, Day 2, Day 3, Day 4, and Day 5
Use of non-opioid analgesics
Time Frame: on day of surgery; on Post-operative Day 1, Day 2, Day 3, Day 4, and Day 5
The investigators will collect the use of non-opioid analgesics data from the patients electronic medical record and via an electronic survey sent to patients.
on day of surgery; on Post-operative Day 1, Day 2, Day 3, Day 4, and Day 5
The difference in the proportion of clinical tolerable pain scores in each group
Time Frame: on Post-operative Day 2, Day 3, Day 4, and Day 5
The investigators will collect the difference in the proportion of clinical tolerable pain scores (defined as Visual Analogue Scale (VAS) ≤ 4) in each group. Subjects will rate their pain level on a scale of 0-10. Number "0" indicates no pain and number "10" indicates terrible pain.
on Post-operative Day 2, Day 3, Day 4, and Day 5
Adverse Block Event Survey
Time Frame: on Post-operative Day 1, Day 2, Day 3, Day 4, Day 5 and Day 30
The investigators will monitor patients for any adverse reaction to the interscalene block by distributing an electronic survey.
on Post-operative Day 1, Day 2, Day 3, Day 4, Day 5 and Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnny K. Lee

Collaborators

Endeavor Health

Investigators

  • Principal Investigator: Johnny K Lee, MD, Endeavor Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2023

Primary Completion (Actual)

October 5, 2025

Study Completion (Actual)

December 1, 2025

Study Registration Dates

First Submitted

May 22, 2023

First Submitted That Met QC Criteria

June 9, 2023

First Posted (Actual)

June 12, 2023

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EH23-069

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be available to other researchers.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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