An interventional study of Liposomal bupivacaine (LB) in Rotator Cuff Tear and Postoperative Pain, sponsored by Orthopaedic & Neurosurgery Specialists. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-02.
Sponsored by Orthopaedic & Neurosurgery Specialists · Not applicable, Interventional, and Supportive care
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.
734 studies on the registry are indexed under Rotator Cuff Injuries; 161 are open to participants now.
This study's enrollment of 50 is below the median of 60 across 538 interventional studies indexed under Rotator Cuff Injuries.
Browse Rotator Cuff Injuries studies →Orthopaedic & Neurosurgery Specialists is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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)
Administration of 20mL of 0.5% standard bupivacaine interscalene block with no additional soft tissue surgical field block
Addition of LB solution to soft tissue surgical field block to a standard interscalene block procedure
Also known as: EXPAREL
Daily Opioid Consumption in Oral Morphine Equivalent
Total amount of narcotics consumed over the study period following surgery
Time frame: Post-operative day one to five
Visual Analog Scale Pain Scores
A standardized measure of subjective pain on a scale of 0 to 10, from zero pain to excruciating pain, respectively
Time frame: Post-operative day one to five
Plan to share: No
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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Orthopaedic & Neurosurgery Specialists