Liposomal Bupivacaine for Pain Control After Rotator Cuff Repair

NCT ID: NCT03692546

Last Updated: 2018-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2018-09-01

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.

Detailed Description

Arthroscopic rotator cuff repair (ARCR) provides excellent clinical outcomes but is often associated with significant postoperative pain. As rotator cuff repair procedures become increasingly more common, these procedures and the narcotic prescriptions which accompany them may contribute to the rising opioid epidemic. The use of intraoperative local and regional anesthesia or field blocks, in conjunction with multimodal pharmacological strategies, is a widely accepted approach for managing surgical pain and reducing opiate use. The purpose of this study was to determine whether using a field block of liposomal bupivacaine (LB) in addition to an interscalene block (ISB) would provide greater pain relief and reduction in opiate consumption when compared to ISB alone.

The study enrolled 50 patients undergoing primary ARCR surgery. Patients were randomized to receiving intraoperative liposomal bupivacaine or not and provided with postoperative "Pain Journals" to document their daily pain on a visual analog scale (VAS) and to track their daily opioid consumption during the first five post-operative days.

Conditions

Rotator Cuff Tear; Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Liposomal Bupivacaine (LB)

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

Group Type: EXPERIMENTAL

Liposomal bupivacaine (LB)

Intervention Type: DRUG

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

Interscalene Block Alone (ISB)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Liposomal bupivacaine (LB)

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

Intervention Type: DRUG

Other Intervention Names

EXPAREL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Orthopaedic & Neurosurgery Specialists

OTHER

Sponsor Role: lead

Responsible Party

Paul Sethi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Orthopaedic & Neurosurgery Specialists

Greenwich, Connecticut, United States

Countries

United States

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Other Identifiers

2016017

Identifier Type: -

Identifier Source: org_study_id