Suspended

Bupivacaine 1.3% Liposomal Suspension (Exparel) vs Continuous Perineural Ropivacaine Infusion in the Management of Post-operative Pain Following Total Shoulder Arthroplasty; An Open-label, Randomized, Controlled Study

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What is being tested

Liposomal Bupivacaine Infiltration

+ Continuous Perineural Ropivicaine Infusion

Drug
Who is being recruted

Neurologic Manifestations+4

+ Pain

+ Pain, Postoperative

Over 18 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: August 2014
See protocol details

Summary

Principal SponsorEric Shepard
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2014

Actual date on which the first participant was enrolled.

Patients undergoing total shoulder arthroplasty commonly receive an interscalene block using ropivacaine to provide analgesia. To provide analgesia for up to 48 hours postoperatively, an indwelling catheter can be placed and a constant infusion of ropivacaine given. This is a safe and very effective technique for managing postoperative pain in this population. This procedure is associated with reduced need for narcotics and improved patient satisfaction. Side effects are uncommon and include catheter displacement and failure of the block. A consequence of this procedure is that it causes paralysis or weakness of the affected arm until the catheter is removed and the drug wears off. Liposomal bupivacaine (Exparel, Pacira Pharmaceuticals, Inc.) was approved by the FDA in October 2011 and is indicated for administration into a surgical site to produce postsurgical analgesia. The duration of analgesia from a single administration is up to 72 hours. Like the ropivicaine constant infusion, Exparel is associated with good patient satisfaction and reduced narcotics requirement. Its advantage over a continuous infusion is that it is technically far less challenging to administer than a catheter insertion and it does not cause paralysis of the affected arm. Investigators are unaware of any studies that compare the efficacy, patient satisfaction, and complication rates of these two different procedures. It is, therefore, the purpose of this investigation to explore these differences. Investigators aim to randomly assign 100 subjects in an open-labeled fashion who are scheduled to have a total shoulder arthroplasty at the UMROI to receive either a continuous infusion of ropivicaine via an interscalene catheter or a single administration of a single dose interscalene nerve block plus Exparel injected into the soft tissue within and around the shoulder during surgery. In this study, investigators plan to use an open label randomized control trial to compare the efficacy of a one time dose of liposomal bupivacaine vs. ropivacaine infusion over 36 hours in providing analgesia. All patients will receive an interscalene block with ropivacaine for operative anesthesia. The patients will be randomized to either receive an indwelling interscalene catheter with a continuous infusion of 6 ml per hour of 0.2% ropivacaine, or surgical wound infiltration of 266 mg of 1.3% liposomal bupivacaine suspension. The patients will be given rescue pain medications as needed and will not be subjected to suffer pain if their pain is not controlled by their local anesthetic. Investigators plan to compare the amounts of rescue pain medications used by the individuals in both groups and the patient reported pain scores to help determine whether local infiltration of liposomal bupivacaine is as effective as a ropivacaine infusion for providing analgesia. If the surgical wound infiltration of liposomal bupivacaine provides the same or improved analgesia, this would benefit future patients and not subject them to having a peripheral nerve catheter placed as they would get equivalent pain relief from a single shot injection followed by wound infiltration with local anesthetic.

Official TitleBupivacaine 1.3% Liposomal Suspension (Exparel) vs Continuous Perineural Ropivacaine Infusion in the Management of Post-operative Pain Following Total Shoulder Arthroplasty; An Open-label, Randomized, Controlled Study
NCT02787226
Principal SponsorEric Shepard
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neurologic ManifestationsPainPain, PostoperativePathologic ProcessesPostoperative ComplicationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Criteria

2 inclusion criteria required to participate
Presenting to University of Maryland Rehabilitation and Orthopaedic Institute for total shoulder arthroplasty (TSA) or reverse TSA

Primary language is English

4 exclusion criteria prevent from participating
Allergy to either ropivacaine or bupivacaine

On chronic opioid therapy at the time of evaluation

Pre-existing neurologic condition which precludes the use of regional anesthesia

Unable to provide consent as determined by the operating surgeons

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Surgical wound infiltration of 266 mg of 1.3% liposomal bupivacaine suspension for postoperative analgesia after reverse total shoulder arthroplasty (TSA).

Group II

Active Comparator
Surgical wound infiltration of 266 mg of 1.3% liposomal bupivacaine suspension for postoperative analgesia after total shoulder arthroplasty (TSA).

Group III

Active Comparator
Indwelling interscalene catheter with a continuous infusion of 6ml per hour of 0.2% ropivacaine for postoperative analgesia after reverse TSA.

Group IV

Active Comparator
Indwelling interscalene catheter with a continuous infusion of 6ml per hour of 0.2% ropivacaine for postoperative analgesia after TSA.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of Maryland Rehabilitation and Orthopaedic Institute

Baltimore, United StatesOpen University of Maryland Rehabilitation and Orthopaedic Institute in Google Maps
SuspendedOne Study Center