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
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
|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.
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, MDfirstname.lastname@example.org|
|United States, New Jersey|
|Cooper University Hospital||Recruiting|
|Camden, New Jersey, United States, 08103|
|Contact: Noud van Helmond, MD 856-968-7336 email@example.com|