Liposomal Bupivacaine in Rotator Cuff Repair

NCT03738696 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: IRB-300002544
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the efficacy of interscalene liposomal bupivacaine in controlling postoperative pain scores, oral morphine equivalents and sleep quality after arthroscopic rotator cuff repair surgery as compared to interscalene catheter.

Conditions

Rotator Cuff Injury

Outcome Measures

Primary Outcomes (1)

• Average Postoperative Pain Scores Over a 96 Hour Timeframe

  Visual analog pain scores after operation \[0-10, with 10 being the worst pain\]

  Up to 96 hrs postoperative

Secondary Outcomes (5)

• Average Postoperative Oral Morphine Equivalents Over a 96 Hour Timeframe

  Up to 96 hrs

• Average Analgesia Satisfaction Over a 96 Hour Timeframe

  Up to 96 hrs

• Percentage of Participants With Analgesia Complications

  Up to 96 hrs

• Average Sleep Quality Over a 96 Hour Timeframe

  Up to 96 hrs postoperative

• Average Hours of Painless Sleep

  Up to 96 hrs postoperative

Study Arms (2)

Liposomal bupivacaine Interscalene Block

EXPERIMENTAL

Interscalene block: * 10cc (133mg) liposomal bupivacaine;PLUS * 10cc 0.25% bupivacaine

Drug: Exparel

Ropivacaine Interscalene Catheter

ACTIVE COMPARATOR

* 20cc 0.25% bupivacaine interscalene block; PLUS * Ropivacaine 0.25% interscalene catheter (6ml/hr for 48hrs)

Drug: Ropivacaine

Interventions

Exparel DRUG

A long-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain

Also known as: liposomal bupivacaine

Liposomal bupivacaine Interscalene Block

Ropivacaine DRUG

A short-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain

Ropivacaine Interscalene Catheter

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing outpatient arthroscopic rotator cuff repair
• Greater than or equal to 19 years of age at the time of surgery

You may not qualify if:

• Planned operative fixation of the biceps tendon or acromioclavicular joint
• Opioid use 6 weeks before surgery
• Gabapentin use 6 weeks before surgery
• History of prior shoulder surgery on the operative limb
• Severe pulmonary dysfunction
• Diagnosis of chronic pain, fibromyalgia or other somatosensory disorder(s)
• History of radicular pain or neuropathy in the operative limb
• Patients who are currently incapacitated for medical decision making

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Pacira Pharmaceuticals, Inc: collaborator

Study Sites (1)

UAB Hospital-Highlands

Birmingham, Alabama, 35205, United States

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Amit Momaya
• Organization: University of Alabama at Birmingham, Department of Orthopaedics

amomaya@uabmc.edu

205-930-8339

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Orthopaedic Surgery

Study Record Dates

• First Submitted: November 7, 2018
• First Posted: November 13, 2018
• Study Start: December 15, 2019
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: May 16, 2024
• Results First Posted: May 16, 2024

Record last verified: 2024-05

Locations

US (1)