Clinical trial NCT03692546: Liposomal Bupivacaine for Pain Control After Rotator Cuff Repair
Official title: Liposomal Bupivacaine Reduces Opiate Consumption After Rotator Cuff Repair in a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tear
Postoperative Pain
Lead sponsor: Orthopaedic & Neurosurgery Specialists
Sponsor class: OTHER
First posted: 2018-10-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Daily Opioid Consumption in Oral Morphine Equivalent
timeFrame: Post-operative day one to five
Secondary outcomes:
measure: Visual Analog Scale Pain Scores
timeFrame: Post-operative day one to five
Other outcomes:
Locations:
city: Greenwich
country: United States
facility: Orthopaedic & Neurosurgery Specialists
state: Connecticut
Study officials:
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