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
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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 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 |

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. |
- 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.

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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 |
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

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