Clinical Trials Directory

Trials / Completed

CompletedNCT03692546

Liposomal Bupivacaine for Pain Control After Rotator Cuff Repair

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
50 (actual)
Sponsor
Orthopaedic & Neurosurgery Specialists · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
DRUGLiposomal bupivacaine (LB)Addition of LB solution to soft tissue surgical field block to a standard interscalene block procedure

Timeline

Start date
2017-02-01
Primary completion
2018-03-01
Completion
2018-09-01
First posted
2018-10-02
Last updated
2018-10-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03692546. Inclusion in this directory is not an endorsement.