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Bupivacaine/Epinephrine +Dexamethasone vs. Liposomal Bupivacaine

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ClinicalTrials.gov Identifier: NCT03906617
Recruitment Status : Recruiting
First Posted : April 8, 2019
Last Update Posted : May 31, 2019
Sponsor:
Information provided by (Responsible Party):
Kingsuk Ganguly, M.D., The Cooper Health System

Study Description
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Brief Summary:
This study will assess analgesia after robotic lung surgery. Subjects will be randomized to receive wound infiltration and intercostal nerve block with either liposomal bupivacaine or bupivacaine/epinephrine + dexamethasone. Liposomal bupivacaine is a newer local anesthetic product and has not been compared to a combination of bupivacaine/epinephrine + dexamethasone in the context of pain control after robotic lung surgery.

Condition or disease Intervention/treatment Phase
Robotic Lung Surgery Drug: Intercostal nerve block and wound infiltration with liposomal bupivacaine Drug: Intercostal nerve block and wound infiltration with bupivacaine/epinephrine + dexamethasone Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Title of Project: Liposomal Bupivacaine (Exparel) Versus Bupivacaine And Dexamethasone Intercostal Nerve Blocks For Robotic Thoracic Surgery: A Prospective Randomized Single-Blinded Clinical Trial
Actual Study Start Date : April 10, 2019
Estimated Primary Completion Date : April 10, 2020
Estimated Study Completion Date : June 10, 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Bupivacaine/epinephrine + dexamethasone Drug: Intercostal nerve block and wound infiltration with bupivacaine/epinephrine + dexamethasone
Intercostal nerve block and wound infiltration with liposomal bupivacaine during robotic lung resection surgery. 42 ml of 0.5% Bupivacaine/epinephrine with 8mg dexamethasone will be used.
Active Comparator: Liposomal bupivacaine Drug: Intercostal nerve block and wound infiltration with liposomal bupivacaine
Intercostal nerve block and wound infiltration with liposomal bupivacaine during robotic lung resection surgery. 266mg of liposomal bupivacaine with 24 ml of 0.5% bupivacaine will be used.


Outcome Measures
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Primary Outcome Measures :
  1. Visual Analogue Scale pain scores [ Time Frame: 24 hours post-surgery ]
    Visual Analogue Scale (VAS) pain score will be assessed for non-inferiority of bupivacaine/epinephrine +dexamethasone vs. liposomal bupivacaine. A non-inferiority margin of 2 points on the VAS scale will be considered non-inferior.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • undergoing robotic wedge resection or lobectomy for lung mass(es)

Exclusion Criteria:

  • emergency case
  • history of opiate abuse
  • chronic pain syndrome
  • intravenous drug use
  • chronic use of oral steroids
  • pregnancy
  • imprisonment
  • body weight lower than 70 kg
  • liver failure
  • uninsured patients
  • non-verbal patients or patients who are unable to rate their pain on a visual analogue pain scale
  • history of allergic reaction to any of the drugs used in the study: bupivacaine, liposomal bupivacaine, dexamethasone
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): NCT03906617


Contacts
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Contact: Noud van Helmond, MD 856-968-7336 vanhelmond-noud@cooperhealth.edu

Locations
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United States, New Jersey
Cooper University Hospital Recruiting
Camden, New Jersey, United States, 08103
Contact: Noud van Helmond, MD    856-968-7336    vanhelmond-noud@cooperhealth.edu   
Sponsors and Collaborators
The Cooper Health System
More Information
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Responsible Party: Kingsuk Ganguly, M.D., Assistant Professor of Anesthesiology, The Cooper Health System
ClinicalTrials.gov Identifier: NCT03906617    
Other Study ID Numbers: 18039
First Posted: April 8, 2019    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019

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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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Dexamethasone
Epinephrine
Bupivacaine
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
Anesthetics, Local
 Anesthetics
Central Nervous System Depressants
Sensory System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents