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Bupivacaine/Epinephrine +Dexamethasone vs. Liposomal Bupivacaine

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: 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

Tracking Information
First Submitted Date  ICMJE April 5, 2019
First Posted Date  ICMJE April 8, 2019
Last Update Posted Date May 31, 2019
Actual Study Start Date  ICMJE April 10, 2019
Estimated Primary Completion Date April 10, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2019)		 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bupivacaine/Epinephrine +Dexamethasone vs. Liposomal Bupivacaine
Official Title  ICMJE Title of Project: Liposomal Bupivacaine (Exparel) Versus Bupivacaine And Dexamethasone Intercostal Nerve Blocks For Robotic Thoracic Surgery: A Prospective Randomized Single-Blinded Clinical Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Robotic Lung Surgery
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Bupivacaine/epinephrine + dexamethasone
    Intervention: Drug: Intercostal nerve block and wound infiltration with bupivacaine/epinephrine + dexamethasone
  • Active Comparator: Liposomal bupivacaine
    Intervention: Drug: Intercostal nerve block and wound infiltration with liposomal bupivacaine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 5, 2019)		 34
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 10, 2020
Estimated Primary Completion Date April 10, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Noud van Helmond, MD 856-968-7336 vanhelmond-noud@cooperhealth.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03906617
Other Study ID Numbers  ICMJE 18039
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kingsuk Ganguly, M.D., The Cooper Health System
Study Sponsor  ICMJE The Cooper Health System
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The Cooper Health System
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP