Title

Liposomal Bupivacaine for Pain Control After Rotator Cuff Repair
Liposomal Bupivacaine Reduces Opiate Consumption After Rotator Cuff Repair in a Randomized Control Trial
  • Phase

    N/A
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Intervention/Treatment

    bupivacaine ...
  • Study Participants

    50
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.
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.
Study Started
Feb 01
2017
Primary Completion
Mar 01
2018
Study Completion
Sep 01
2018
Last Update
Oct 02
2018

Drug Liposomal bupivacaine (LB)

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

  • Other names: EXPAREL

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

Interscalene Block Alone (ISB) No Intervention

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

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
No Results Posted