Liposomal Bupivacaine for Pain Control After Rotator Cuff Repair

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03692546
• Other study ID #: 2016017
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: September 1, 2018

Study information

• Verified date: September 2018
• Source: Orthopaedic & Neurosurgery Specialists
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain
• Rotator Cuff Injuries
• Rotator Cuff Tear

Intervention

Drug:
• Liposomal bupivacaine (LB)
Addition of LB solution to soft tissue surgical field block to a standard interscalene block procedure

Locations

Country	Name	City	State
United States	Orthopaedic & Neurosurgery Specialists	Greenwich	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Orthopaedic & Neurosurgery Specialists

Country where clinical trial is conducted

United States, 

References & Publications (26)

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily Opioid Consumption in Oral Morphine Equivalent	Total amount of narcotics consumed over the study period following surgery	Post-operative day one to five
Secondary	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	Post-operative day one to five