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

NCT02787226 | Terminated Phase 4 DMC

• 1 other identifier: HP-00054364
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

liposomal bupivacaine; analgesia for total shoulder arthroplasty; peripheral nerve blocks for total shoulder arthroplasty

Outcome Measures

Primary Outcomes (1)

• Pain scores

  0-36 hours post-operatively

Secondary Outcomes (4)

• Opioid-Related Adverse Events

  0-36 hours post-operatively

• Length of stay

  1-3 days

• Rescue pain medication requirement

  0-36 hours postoperatively

• Patient satisfaction

  at 3 months post-operatively

Study Arms (4)

TSA - Liposomal Bupivacaine Infiltration

ACTIVE COMPARATOR

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

Drug: Liposomal Bupivacaine Infiltration

Reverse TSA - Liposomal Bupivacaine Infiltration

ACTIVE COMPARATOR

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

Drug: Liposomal Bupivacaine Infiltration

TSA - Continuous Perineural Ropivacaine Infusion

ACTIVE COMPARATOR

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

Drug: Continuous Perineural Ropivicaine Infusion

Reverse TSA - Continuous Perineural Ropivacaine Infusion

ACTIVE COMPARATOR

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

Drug: Continuous Perineural Ropivicaine Infusion

Interventions

Liposomal Bupivacaine Infiltration DRUG

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

Also known as: Exparel

Reverse TSA - Liposomal Bupivacaine Infiltration; TSA - Liposomal Bupivacaine Infiltration

Continuous Perineural Ropivicaine Infusion DRUG

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

Reverse TSA - Continuous Perineural Ropivacaine Infusion; TSA - Continuous Perineural Ropivacaine Infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eric Shepard: lead
• Pacira Pharmaceuticals, Inc: collaborator

Study Sites (1)

University of Maryland Rehabilitation and Orthopaedic Institute

Baltimore, Maryland, 21207, United States

Location

Related Publications (3)

• Grant GJ, Lax J, Susser L, Zakowski M, Weissman TE, Turndorf H. Wound infiltration with liposomal bupivacaine prolongs analgesia in rats. Acta Anaesthesiol Scand. 1997 Feb;41(2):204-7. doi: 10.1111/j.1399-6576.1997.tb04666.x.

  PMID: 9062600 BACKGROUND

• Grant GJ, Barenholz Y, Bolotin EM, Bansinath M, Turndorf H, Piskoun B, Davidson EM. A novel liposomal bupivacaine formulation to produce ultralong-acting analgesia. Anesthesiology. 2004 Jul;101(1):133-7. doi: 10.1097/00000542-200407000-00021.

  PMID: 15220782 BACKGROUND

• Hollmann MW, Durieux ME, Graf BM. Novel local anaesthetics and novel indications for local anaesthetics. Curr Opin Anaesthesiol. 2001 Dec;14(6):741-9. doi: 10.1097/00001503-200112000-00023.

  PMID: 17019174 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Eric K Shepard, MD

  University of Maryland Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Department of Anesthesiology

Study Record Dates

• First Submitted: May 26, 2016
• First Posted: June 1, 2016
• Study Start: August 1, 2014
• Primary Completion: April 28, 2017
• Study Completion: May 31, 2017
• Last Updated: February 9, 2018

Record last verified: 2018-02

Locations

US (1)