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Liposome Bupivacaine Interscalene Total Shoulder

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03587636
Recruitment Status : Recruiting
First Posted : July 16, 2018
Last Update Posted : August 27, 2020
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Brief Summary:
This is a randomized prospective outcomes study comparing two groups of patients. One group will receive liposomal bupivacaine plus bupivacaine and the other will receive bupivacaine alone in interscalene blocks when undergoing total shoulder arthroplasty. The purpose of the study is to determine if LB plus bupivacaine provides superior pain control compared to bupivacaine alone when injected in an interscalene block for patients undergoing total shoulder arthroplasty surgery.

Condition or disease Intervention/treatment Phase
Acute Pain Drug: liposome bupivacaine Drug: Bupivacaine Phase 2

Detailed Description:

Liposomal bupivacaine (LB) is a long acting local anesthetic. It is liposome encapsulated bupivacaine which allows for prolonged release of bupivacaine over a 72-hour period. Bupivacaine is a medium acting local anesthetic which provides between 6 and 24 hours of analgesia when used in a peripheral nerve block. Both medications are standard of care for use in interscalene blocks here at the U of MN.

LB has not been adequately studied in peripheral nerve blocks and has yet to be studied for use in interscalene blocks for Total Shoulder Arthroplasty (TSA) patients. It has been studied in Rotator Cuff Repairs (RCR) surgery and showed superior analgesia compared to bupivacaine.

The purpose of the study is to determine if LB plus bupivacaine provides superior pain control compared to bupivacaine alone when injected in an interscalene block for patients undergoing total shoulder arthroplasty surgery.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Randomized Controlled Trial Comparing Liposomal Bupivacaine to Bupivacaine Interscalene Blocks for Total Shoulder Arthroplasty Surgery; a Pilot Study
Actual Study Start Date : July 17, 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Liposome bupivacaine interscalene block
10 mL of liposome bupivacaine and 10 mL of 0.5% bupivacaine will be injected at the interscalene brachial plexus under ultrasound guidance
Drug: liposome bupivacaine
interscalene block with liposomal bupivacaine plus bupivacaine
Other Name: bupivacaine

Active Comparator: bupivacaine interscalene block
20 mL of 0.5% bupivacaine will be injected at the interscalene brachial plexus under ultrasound guidance.
Drug: Bupivacaine
interscalene block with bupivacaine




Primary Outcome Measures :
  1. Total opioid use [ Time Frame: From end of surgery through 72 hours after end of surgery ]
    total amount of opioid use from after surgery through 72 hours. Opioids normalized to morphine equivalents


Secondary Outcome Measures :
  1. Total maximum pain scores f [ Time Frame: time from end of surgery through 72 hours after end of surgery ]
    Sum total of maximal pain scores through 72 horus after surgery. Pain scores reported on a numerical rating scale from 0-10. 10 is worse and 0 is best


Other Outcome Measures:
  1. Overall benefit of analgesia score [ Time Frame: survey occurring at 72 hours after the end of surgery ]
    Score on the overall benefit of analgesia rating scale via the overall benefit of analgesia survey taken at the 72 hour mark. higher scores are worse. range 0-28

  2. Quality of recovery 15 score [ Time Frame: survey occurring at 72 hours after the end of surgery ]
    Score on the quality of recovery 15 survey taken at the 72 hour mark. higher score is better. score range 0-150



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All adult patients aged greater than 18 years of age that are undergoing total or reverse total shoulder arthroplasty

Exclusion Criteria:

  • Patients with allergy to local anesthetics, daily use of opioids for more than 3 weeks prior to surgery, patient refusal, patient with coagulopathy, non-english speaking patients, and those who do not have access to a telephone.

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): NCT03587636


Contacts
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Contact: James Flaherty, MD 612-624-9990 jflahert@umn.edu
Contact: Melissa Cohen Cohen045@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Melissa Cohen    612-625-7116      
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: James Flaherty, MD University of Minnesota
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT03587636    
Other Study ID Numbers: ANES-2018-26661
First Posted: July 16, 2018    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents