Liposomal Bupivacaine After Arthroscopic Rotator Cuff Repair

NCT03149887 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: PRO17020089
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Liposomal bupivacaine, a long-acting form of bupivacaine, has been found to be effective for postoperative pain control after total knee, total hip and total shoulder arthroplasty. We are conducting a randomized, controlled trial to evaluate pain control after arthroscopic rotator cuff repair in ambulatory patients, comparing standard care in the control group, with standard care plus the addition of injection of liposomal bupivacaine in the experimental group.

Conditions

Rotator Cuff Tear

Outcome Measures

Primary Outcomes (1)

• Numeric Rating Pain Score [NRS] at Time of Block Resolution

  Numeric rating score pain level at time of nerve block resolution, on scale of 0-10, as reported by patient at time of 24 hour follow up phone call. A reported score of zero implies no pain, whereas a score of "10" implies very severe pain. Outcome score is mean of reported pain scores by participants at time of nerve block resolution.

  At the time of block resolution, as reported by patients at follow up phone call

Secondary Outcomes (7)

• Mean NRS Pain Score at Rest on Postoperative Day 1

  Postoperative day 1

• Mean NRS Pain Score at Rest on Postoperative Day 2

  Postoperative day 2

• Mean NRS Pain Scores at Rest on Postoperative Day 3

  Postoperative Day 3

• Mean NRS Pain Score With Motion

  Mean value of reported pain scores on postoperative days 1,2 and 3

• Oral Analgesic Requirements on Postoperative Day 1

  Postoperative day 1

Study Arms (2)

Experimental

EXPERIMENTAL

Injection of liposomal bupivacaine in surgical field at end of arthroscopic rotator cuff repair.

Drug: Liposomal bupivacaine

Control

ACTIVE COMPARATOR

Injection of inert placebo solution in surgical field at end of arthroscopic rotator cuff repair.

Drug: Placebo

Interventions

Liposomal bupivacaine DRUG

Liposomal bupivacaine solution (Exparel) for injection

Also known as: Exparel

Experimental

Placebo DRUG

Inert solution created to appear as liposomal bupivacaine (Exparel) for injection

Also known as: Placebo solution for liposomal bupivacaine (Exparel)

Control

Eligibility Criteria

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

You may qualify if:

• Adult patients up to age 65 years, undergoing elective, ambulatory, arthroscopic rotator cuff repair.

You may not qualify if:

• Pregnancy, coagulopathy, allergy to bupivacaine, renal failure, hepatic insufficiency, and/or inappropriate candidate for usual therapy (specifically, if unable to receive the usual preoperative interscalene nerve block: preexisting nerve injury on side of surgery, refusal of nerve block, infection at site of nerve block).

Sponsors & Collaborators

• Steven Orebaugh: lead
• Pacira Pharmaceuticals, Inc: collaborator

Study Sites (1)

University of Pittsburgh Medical Center-Southside/Mercy

Pittsburgh, Pennsylvania, 15203, United States

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Results Point of Contact

• Title: Dr. Steven L. Orebaugh
• Organization: UPittsburgh

orebaughsl@anes.upmc.edu

412-877-5832

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Anesthesiology

Model Details: Randomized, controlled, parallel

Study Record Dates

• First Submitted: May 9, 2017
• First Posted: May 11, 2017
• Study Start: December 5, 2017
• Primary Completion: February 26, 2019
• Study Completion: March 1, 2019
• Last Updated: January 23, 2020
• Results First Posted: January 23, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)