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Liposomal Bupivacaine Infiltration vs Continuous Perineural Ropivacaine Infusion for Post-operative Pain After Total Shoulder Arthroplasty

NCT02787226 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-02-09

No results posted yet for this study

Summary

Total shoulder replacement is associated with considerable postoperative pain. A common method to treat and prevent this post operative pain is to place a catheter in the neck and leave it in place for up to 48 hours. The catheter delivers a medication called ropivacaine directly to a major nerve near your shoulder. It is very effective at stopping pain. In addition to preventing pain, it also prevents movement of the arm because it blocks the nerve completely.

A newer method of treating post operative pain uses only a series of small injections into the joint, skin, and muscles of the shoulder near the end of the surgery. This medication, liposomal bupivacaine (Exparel), potentially provides analgesia for greater than 48 hrs but does not require a catheter to remain in place and does not prevent patients from moving their arm after surgery because it only blocks the pain portion of the nerve. Both methods also frequently include the addition of oral and injected pain medicines like narcotics to effectively control the pain.

Ropivacaine and Exparel both work well for postoperative pain after total shoulder replacement. It is not known, however, if one method is superior in its ability to treat/prevent pain or which method may have fewer side effects. The purpose of this study is to randomly assign patients to receive either a catheter with ropivicaine or Exparel injections to help determine if one method is superior in pain relief and if either method has fewer side effects.

Conditions

  • Postoperative Pain
  • Shoulder Arthritis

Interventions

DRUG

Liposomal Bupivacaine Infiltration

Surgical wound infiltration of 266 mg of 1.3% liposomal bupivacaine suspension.

DRUG

Continuous Perineural Ropivicaine Infusion

Indwelling interscalene catheter with a continuous infusion of 6ml per hour of 0.2% ropivacaine.

Sponsors & Collaborators

  • Pacira Pharmaceuticals, Inc

    collaborator INDUSTRY

  • Eric Shepard

    lead OTHER

Principal Investigators

  • Eric K Shepard, MD · University of Maryland Department of Anesthesiology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2017-04-28
Completion
2017-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02787226 on ClinicalTrials.gov