Bupivacaine/Epinephrine +Dexamethasone vs. Liposomal Bupivacaine

Sponsor
The Cooper Health System (Other)
Overall Status
Recruiting
CT.gov ID
NCT03906617
Collaborator
(none)
34
1
2
38
0.9

Study Details

Study Description

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
  • 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

Study Type:
Interventional
Anticipated 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 :
Apr 10, 2019
Anticipated Primary Completion Date :
Apr 10, 2022
Anticipated Study Completion Date :
Jun 10, 2022

Arms and Interventions

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

Primary Outcome Measures

  1. Visual Analogue Scale pain scores [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

Criteria

Ages Eligible for Study:
18 Years to 90 Years
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cooper University Hospital Camden New Jersey United States 08103

Sponsors and Collaborators

  • The Cooper Health System

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Apr 8, 2019
Last Update Posted:
Nov 12, 2021
Last Verified:
Nov 1, 2021
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:

Study Results

No Results Posted as of Nov 12, 2021