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Post-operative Exparel Study Following Rotator Cuff Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04047745
Recruitment Status : Unknown
Verified August 2019 by Rothman Institute Orthopaedics.
Recruitment status was:  Not yet recruiting
First Posted : August 7, 2019
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

Study Description
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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.

Condition or disease Intervention/treatment Phase
Rotator Cuff Tears Drug: Liposomal bupivacaine Drug: Ropivacaine injection Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of Liposomal Bupivacaine Interscalene Brachial Plexus Block for Rotator Cuff Surgery: A Randomized, Double Blind, Clinical Trial
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: liposomal bupivacaine Drug: Liposomal bupivacaine
interscalene nerve block administered before surgery using 133 mg liposomal bupivacaine with 10mL 0.5% ropivacaine
Active Comparator: ropivacaine Drug: Ropivacaine injection
interscale nerve block administered before surgery using 30mL 0.5% ropivacaine


Outcome Measures
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Primary Outcome Measures :
  1. opioid consumption [ Time Frame: surgery through 48 hours post-op ]
    postsurgical opioid consumption


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04047745


Contacts
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Contact: Director of Clinical Trials 267-339-7818 tiffany.morrison@rothmanortho.com

Locations
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United States, New Jersey
Rothman Orthopaedics at Egg Harbor Township
Egg Harbor Township, New Jersey, United States, 08234
Sponsors and Collaborators
Rothman Institute Orthopaedics
More Information
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Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT04047745    
Other Study ID Numbers: 2019Tucker
First Posted: August 7, 2019    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Bupivacaine
Ropivacaine
 Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents