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

• Status: Terminated
• Trial end date: 2017-05-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eric Shepard
• Collaborator: Pacira Pharmaceuticals, Inc
• Treatments: Bupivacaine; Ropivacaine

Criteria

Inclusion Criteria:

• Presenting to University of Maryland Rehabilitation and Orthopaedic Institute for total shoulder arthroplasty (TSA) or reverse TSA

• Primary language is English

Exclusion Criteria:

• 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