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Post-operative Exparel Study Following Rotator Cuff Repair

Primary Purpose

Rotator Cuff Tears

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Liposomal bupivacaine
Ropivacaine injection
Sponsored by
Rothman Institute Orthopaedics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tears

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Males and females aged 18 years or older with a full-thickness rotator cuff tear (confirmed on MRI) undergoing arthroscopic rotator cuff repair surgery.
  • Anesthesiologists physical status 1, 2, or 3 and normal preoperative motor (Lovett scale: biceps, wrist, thumb) and sensory function.

Exclusion Criteria:

  • Revision shoulder surgery
  • History of more than 1 prior surgery performed on the operative shoulder
  • Concomitant severe glenohumeral arthritis
  • Concomitant adhesive capsulitis
  • Worker's compensation claim
  • Pregnancy
  • History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics
  • History of renal or hepatic failure
  • Chronic neuromuscular deficit affecting the surgical limb.
  • Uncontrolled psychiatric or neurologic disorder

Sites / Locations

  • Rothman Orthopaedics at Egg Harbor Township

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

liposomal bupivacaine

ropivacaine

Arm Description

Outcomes

Primary Outcome Measures

opioid consumption
postsurgical opioid consumption

Secondary Outcome Measures

Full Information

First Posted
August 5, 2019
Last Updated
August 6, 2019
Sponsor
Rothman Institute Orthopaedics
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1. Study Identification

Unique Protocol Identification Number
NCT04047745
Brief Title
Post-operative Exparel Study Following Rotator Cuff Repair
Official Title
The Use of Liposomal Bupivacaine Interscalene Brachial Plexus Block for Rotator Cuff Surgery: A Randomized, Double Blind, Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 2019 (Anticipated)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rothman Institute Orthopaedics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The primary purpose of this study is to determine if the postoperative oral narcotics consumption in patients receiving liposomal bupivacaine (LB) interscalene brachial plexus nerve block (ISBPB) is different than the narcotics consumption receiving traditional bupivacaine ISBPB for arthroscopic rotator cuff repair analgesia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tears

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
liposomal bupivacaine
Arm Type
Active Comparator
Arm Title
ropivacaine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Liposomal bupivacaine
Intervention Description
interscalene nerve block administered before surgery using 133 mg liposomal bupivacaine with 10mL 0.5% ropivacaine
Intervention Type
Drug
Intervention Name(s)
Ropivacaine injection
Intervention Description
interscale nerve block administered before surgery using 30mL 0.5% ropivacaine
Primary Outcome Measure Information:
Title
opioid consumption
Description
postsurgical opioid consumption
Time Frame
surgery through 48 hours post-op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and females aged 18 years or older with a full-thickness rotator cuff tear (confirmed on MRI) undergoing arthroscopic rotator cuff repair surgery. Anesthesiologists physical status 1, 2, or 3 and normal preoperative motor (Lovett scale: biceps, wrist, thumb) and sensory function. Exclusion Criteria: Revision shoulder surgery History of more than 1 prior surgery performed on the operative shoulder Concomitant severe glenohumeral arthritis Concomitant adhesive capsulitis Worker's compensation claim Pregnancy History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics History of renal or hepatic failure Chronic neuromuscular deficit affecting the surgical limb. Uncontrolled psychiatric or neurologic disorder
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Director of Clinical Trials
Phone
267-339-7818
Email
tiffany.morrison@rothmanortho.com
Facility Information:
Facility Name
Rothman Orthopaedics at Egg Harbor Township
City
Egg Harbor Township
State/Province
New Jersey
ZIP/Postal Code
08234
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Post-operative Exparel Study Following Rotator Cuff Repair

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