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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03692546
Enrollment
50
Registered
2018-10-02
Start date
2017-02-01
Completion date
2018-09-01
Last updated
2018-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotator Cuff Tear, Postoperative Pain

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.

Interventions

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

Sponsors

Orthopaedic & Neurosurgery Specialists
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Daily Opioid Consumption in Oral Morphine EquivalentPost-operative day one to fiveTotal amount of narcotics consumed over the study period following surgery

Secondary

MeasureTime frameDescription
Visual Analog Scale Pain ScoresPost-operative day one to fiveA standardized measure of subjective pain on a scale of 0 to 10, from zero pain to excruciating pain, respectively

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026