- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03906617
Bupivacaine/Epinephrine +Dexamethasone vs. Liposomal Bupivacaine
November 11, 2021 updated by: Kingsuk Ganguly, M.D., The Cooper Health System
Title of Project: Liposomal Bupivacaine (Exparel) Versus Bupivacaine And Dexamethasone Intercostal Nerve Blocks For Robotic Thoracic Surgery: A Prospective Randomized Single-Blinded Clinical Trial
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Anticipated)
34
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Noud van Helmond, MD
- Phone Number: 856-968-7336
- Email: vanhelmond-noud@cooperhealth.edu
Study Locations
-
-
New Jersey
-
Camden, New Jersey, United States, 08103
- Recruiting
- Cooper University Hospital
-
Contact:
- Noud van Helmond, MD
- Phone Number: 856-968-7336
- Email: vanhelmond-noud@cooperhealth.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
24 hours post-surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 10, 2019
Primary Completion (Anticipated)
April 10, 2022
Study Completion (Anticipated)
June 10, 2022
Study Registration Dates
First Submitted
April 5, 2019
First Submitted That Met QC Criteria
April 5, 2019
First Posted (Actual)
April 8, 2019
Study Record Updates
Last Update Posted (Actual)
November 12, 2021
Last Update Submitted That Met QC Criteria
November 11, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Anesthetics, Local
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Dexamethasone
- Bupivacaine
- Epinephrine
Other Study ID Numbers
- 18039
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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