Skip to main content
OpenTrials
Completed

NCT Number: NCT03692546

Liposomal Bupivacaine for Pain Control After Rotator Cuff Repair

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthopaedic & Neurosurgery Specialists

Greenwich, Connecticut, 06831, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Liposomal bupivacaine (LB)

Drug

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

Other names: EXPAREL

Primary outcomes

  1. Daily Opioid Consumption in Oral Morphine Equivalent

    Time frame: Post-operative day one to five

    Total amount of narcotics consumed over the study period following surgery

Secondary outcomes

  1. Visual Analog Scale Pain Scores

    Time frame: Post-operative day one to five

    A standardized measure of subjective pain on a scale of 0 to 10, from zero pain to excruciating pain, respectively

Sponsors and collaborators

Lead sponsor

Orthopaedic & Neurosurgery Specialists

Other

Registry information

Official study title

Liposomal Bupivacaine Reduces Opiate Consumption After Rotator Cuff Repair in a Randomized Control Trial

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 2, 2018
Registry last updated
Oct 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.