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Single Shot Liposomal Bupivicaine in Rotator Cuff Surgery

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ClinicalTrials.gov Identifier: NCT03822182
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
Brian Badman, Indiana University

Brief Summary:

This document is a protocol for a human research study. This study is to be conducted according to United States standards of Good Clinical Practice in accordance with applicable Federal regulations and institutional research policies and procedures.

Liposomal bupivacaine (LB) has been shown to decrease post-operative pain and narcotic use when administered perioperatively as a local injection during arthroplasty procedures. Studies have also demonstrated that LB used in conjunction with dexamethasone may increase the duration of effectiveness of LB. This study seeks to evaluate if there is a difference in post-operative pain and narcotic use when LB is administered in an interscalene block during outpatient rotator cuff repair surgery. Furthermore, this study aims to determine if the addition of dexamethasone with LB results in a prolonged decrease in post-operative pain and a reduction in narcotic use.


Condition or disease Intervention/treatment Phase
Rotator Cuff Tear Pain, Postoperative Drug: liposomal bupivicaine Drug: Dexamethasone Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

The medication administered in the interscalene block is the intervention in this study. There are three different types of interscalene blocks that will be administered in order to compare the independent effectiveness of LB with the effectiveness of LB plus dexamethasone. Study participants will be randomized into one of three groups. The treatment groups are listed below:

Group 1 (Control) Group 2 Group 3 30 ml of 0.5% bupivacaine and 0.4ml. of dexamethasone 15ml 0.5% bupivacaine and 10ml of LB (Exparel) and 5.4ml normal saline 15ml 0.5% bupivacaine and 10ml LB (Exparel) and 0.4ml dexamethasone and 5ml normal saline

Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: This is a double-blinded study, thus, neither the surgeon nor the patient will know which type of interscalene block is used. A total of 78 envelopes containing will be generated consisting of 26 with Group 1", 26 with "Group 2" and 26 with "Group 3" designation. Envelopes will be sealed and randomly chosen by the anesthesiologist prior to surgery. The anesthesiologist will randomly select one of the envelopes which will determine the treatment group and indicate medications that will be included in the interscalene block. Patients will be blinded to the medication utilized as well as the treating surgeon.
Primary Purpose: Treatment
Official Title: A Prospective Randomized Controlled Trial Examining the Effectiveness of a Single Shot of Liposomal Bupivicaine for Reducing Post-operative Pain and Narcotic Use in Outpatient Rotator Cuff Surgery
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
group 1 control
Group 1 will serve as the control and receive the standard injection consisting 30 ml of 0.5% bupivacaine and 0.4ml (4 mg) of dexamethasone.
Drug: Dexamethasone
steroid that will be used in control as well as in group 3 to see if effect with liposomal bupivicaine is prolonged as has been shown with standard bupivicaine.

Active Comparator: group 2
Group 2 will receive a block with 15ml 0.5% bupivacaine and 10ml (133mg) of liposomal bupivicaine (Exparel) and 5.4ml of Normal Saline
Drug: liposomal bupivicaine

The medication administered in the interscalene block is the intervention in this study. There are three different types of interscalene blocks that will be administered in order to compare the independent effectiveness of LB with the effectiveness of LB plus dexamethasone. Study participants will be randomized into one of three groups. The treatment groups are listed below:

Group 1 (Control): 30 ml of 0.5% bupivacaine and 0.4ml (4 mg) of dexamethasone Group 2: 15ml 0.5% bupivacaine and 10ml (133mg) of LB (Exparel) and 5.4ml normal saline Group 3: 5ml 0.5% bupivacaine and 10ml LB (Exparel) and 0.4ml (4 mg) dexamethasone and 5ml normal saline

Other Name: Exparel

Active Comparator: Group 3
Group 3 will receive 15ml of 0.5% bupivicaine and 10ml (133mg) of Liposomal Bupivicaine (Exparel) and 0.4ml (4mg) dexamethasone and 5ml normal saline
Drug: liposomal bupivicaine

The medication administered in the interscalene block is the intervention in this study. There are three different types of interscalene blocks that will be administered in order to compare the independent effectiveness of LB with the effectiveness of LB plus dexamethasone. Study participants will be randomized into one of three groups. The treatment groups are listed below:

Group 1 (Control): 30 ml of 0.5% bupivacaine and 0.4ml (4 mg) of dexamethasone Group 2: 15ml 0.5% bupivacaine and 10ml (133mg) of LB (Exparel) and 5.4ml normal saline Group 3: 5ml 0.5% bupivacaine and 10ml LB (Exparel) and 0.4ml (4 mg) dexamethasone and 5ml normal saline

Other Name: Exparel

Drug: Dexamethasone
steroid that will be used in control as well as in group 3 to see if effect with liposomal bupivicaine is prolonged as has been shown with standard bupivicaine.




Primary Outcome Measures :
  1. Patient Reported postoperative pain: VAS [ Time Frame: 5 days post procedure ]
    Patient-reported post-operative VAS pain (on a scale of 1-10), measured post operatively, in 8-hour increments, for a total of 120 hours post-surgery Patients will be prompted via text message to provide VAS pain every 8 hours. If a response text message is not received, a phone call will be made to obtain the information. Patients who do not have a smart phone will receive a phone call or keep a personal log of VAS pain.


Secondary Outcome Measures :
  1. Patient reported post operative opioid use [ Time Frame: 5 days post procedure ]
    Patient-reported post-operative opioid use (converted to morphine equivalents), collected post operatively, in 8-hour increments, for a total of 120 hours post-surgery Patients will be prompted via text message to provide the amount of narcotics (number of pills converted to morphine equivalents) taken over the course of the previous 8 hours. If a response text message is not received, a phone call will be made to obtain the information. Patients who do not have a smart phone will receive a phone call or keep a personal log of narcotic use.



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:

  • Age 18 and older
  • Primary diagnosis of rotator cuff tear
  • Able to provide informed consent
  • Is willing and able to accept text messages

Exclusion Criteria:

  • Known allergies to the study medications.
  • Known narcotic or alcohol abuse (< 3 months)
  • Revision rotator cuff surgery
  • Contraindication to regional anesthesia
  • Current narcotic regimen or contract with pain management specialist
  • Diagnosed with any of the following co-morbidities:

    • Pre-existing coagulation disorder

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): NCT03822182


Contacts
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Contact: Brian Badman, MD 3178328800 bbadman@gmail.com

Locations
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United States, Indiana
American Health Network Recruiting
Avon, Indiana, United States, 46123
Contact: Brian Badman, MD    317-208-3866    bbadman@gmail.com   
Contact: james creighton, MD    3173137061    james.creigthon.md@gmail.com   
Sponsors and Collaborators
Indiana University
Investigators
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Principal Investigator: brian badman, MD Indiana University

Publications:
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Responsible Party: Brian Badman, Principal Investigator, Clinical Associate Professor, Department of Orthopedic Surgery, Indiana University
ClinicalTrials.gov Identifier: NCT03822182     History of Changes
Other Study ID Numbers: 1806933448
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plans to share

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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.: No
Keywords provided by Brian Badman, Indiana University:
liposomal bupivicaine
interscalene block
Additional relevant MeSH terms:
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Pain, Postoperative
Rotator Cuff Injuries
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Dexamethasone
Dexamethasone acetate
Bupivacaine
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local