Liposomal Bupivacaine for Pain Control After Rotator Cuff Repair

NCT03692546 | Completed

• 1 other identifier: 2016017
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The use of an interscalene block (ISB) is often associated with rebound pain that could be avoided through adjunctive therapy with longer duration. Administration of a liposomal bupivacaine (LB) field block in addition to ISB would overcome this rebound pain to provide greater pain relief and reduce opiate consumption when compared to ISB alone. 50 patients were recruited and randomized into groups that either received or did not receive an intraoperative LB field block in addition to standard ISB administration. Visual Analog Scale (VAS) pain scores and narcotic consumption were recorded over the five-day postoperative period to determine the effectiveness of LB pain relief.

Conditions

Rotator Cuff Tear; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Daily Opioid Consumption in Oral Morphine Equivalent

  Total amount of narcotics consumed over the study period following surgery

  Post-operative day one to five

Secondary Outcomes (1)

• Visual Analog Scale Pain Scores

  Post-operative day one to five

Study Arms (2)

Liposomal Bupivacaine (LB)

EXPERIMENTAL

Administration of 20 ml of LB diluted with an additional 40 ml of saline was injected into a triangular soft tissue surgical field block, along with standard bupivacaine interscalene block

Drug: Liposomal bupivacaine (LB)

Interscalene Block Alone (ISB)

NO INTERVENTION

Administration of 20mL of 0.5% standard bupivacaine interscalene block with no additional soft tissue surgical field block

Interventions

Liposomal bupivacaine (LB) DRUG

Addition of LB solution to soft tissue surgical field block to a standard interscalene block procedure

Also known as: EXPAREL

Liposomal Bupivacaine (LB)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• at least 18 years of age
• undergoing an arthroscopic rotator cuff repair surgery of a full thickness tear
• willing to fill out the "Pain Journal"; able to understand the informed consent process
• willing to document informed consent prior to completion of any study-related procedure
• able to read, comprehend, and complete subject-reported outcome measures in English

You may not qualify if:

• pregnant
• documented history of drug or alcohol abuse
• use of narcotic painkillers greater than 3 months prior to surgery
• neurologic deficit or disability involving the surgical extremity
• known allergy or intolerance to hydrocodone or oxycodone
• known allergy to amide anesthetics
• currently enrolled or planning to enroll in another clinical trial during this study that would affect the outcome of this study
• history of cognitive or mental health status that interferes with study participation

Sponsors & Collaborators

• Orthopaedic & Neurosurgery Specialists: lead

Study Sites (1)

Orthopaedic & Neurosurgery Specialists

Greenwich, Connecticut, 06831, United States

Location

Related Publications (26)

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  BACKGROUND

• Westermann RW, Anthony CA, Bedard N, Glass N, Bollier M, Hettrich CM, Wolf BR. Opioid Consumption After Rotator Cuff Repair. Arthroscopy. 2017 Aug;33(8):1467-1472. doi: 10.1016/j.arthro.2017.03.016. Epub 2017 May 29.

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MeSH Terms

Conditions

Rotator Cuff Injuries; Pain, Postoperative

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: October 2, 2018
• Study Start: February 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: September 1, 2018
• Last Updated: October 2, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)