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Liposomal Bupivacaine for Pain Control After Rotator Cuff Repair

Primary Purpose

Rotator Cuff Tear, Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Liposomal bupivacaine (LB)
Sponsored by
Orthopaedic & Neurosurgery Specialists
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Rotator Cuff Tear

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Orthopaedic & Neurosurgery Specialists

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Liposomal Bupivacaine (LB)

Interscalene Block Alone (ISB)

Arm Description

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

Administration of 20mL of 0.5% standard bupivacaine interscalene block with no additional soft tissue surgical field block

Outcomes

Primary Outcome Measures

Daily Opioid Consumption in Oral Morphine Equivalent
Total amount of narcotics consumed over the study period following surgery

Secondary Outcome Measures

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

Full Information

First Posted
September 26, 2018
Last Updated
September 30, 2018
Sponsor
Orthopaedic & Neurosurgery Specialists
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1. Study Identification

Unique Protocol Identification Number
NCT03692546
Brief Title
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

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
March 1, 2018 (Actual)
Study Completion Date
September 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Orthopaedic & Neurosurgery Specialists

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear, Postoperative Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liposomal Bupivacaine (LB)
Arm Type
Experimental
Arm Description
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
Arm Title
Interscalene Block Alone (ISB)
Arm Type
No Intervention
Arm Description
Administration of 20mL of 0.5% standard bupivacaine interscalene block with no additional soft tissue surgical field block
Intervention Type
Drug
Intervention Name(s)
Liposomal bupivacaine (LB)
Other Intervention Name(s)
EXPAREL
Intervention Description
Addition of LB solution to soft tissue surgical field block to a standard interscalene block procedure
Primary Outcome Measure Information:
Title
Daily Opioid Consumption in Oral Morphine Equivalent
Description
Total amount of narcotics consumed over the study period following surgery
Time Frame
Post-operative day one to five
Secondary Outcome Measure Information:
Title
Visual Analog Scale Pain Scores
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Orthopaedic & Neurosurgery Specialists
City
Greenwich
State/Province
Connecticut
ZIP/Postal Code
06831
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Liposomal Bupivacaine for Pain Control After Rotator Cuff Repair

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