Recruiting

Bupivacaine & Dexamethasone

Sponsor:

The Cooper Health System

Code:

NCT03906617

Conditions

Robotic Lung Surgery

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Intercostal nerve block and wound infiltration with liposomal bupivacaine

Intercostal nerve block and wound infiltration with bupivacaine/epinephrine + dexamethasone

Study Details

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.

Conditions

Robotic Lung Surgery

Study ID

NCT03906617

Start date

Apr 10, 2019

Status verified date

Nov, 2021

Completion date

Jun 10, 2022

Anticipated

Primary completion date

Apr 10, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

34 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Bupivacaine/epinephrine + dexamethasone

active comparator: Liposomal bupivacaine

Interventions

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.

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.

Primary outcome measure

  • Visual Analogue Scale pain scores [ Time Frame: 24 hours post-surgery ]

Central Contacts and Locations

Central contacts

Noud van Helmond, MD

856-968-7336vanhelmond-noud@cooperhealth.edu

Locations

Cooper University Hospital

Recruiting

Camden, New Jersey, United States, 08103

Contacts

Noud van Helmond, MD

856-968-7336vanhelmond-noud@cooperhealth.edu

More Information

Sponsor

The Cooper Health System

Last update posted

Nov 12, 2021

Last verified

Nov, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cooper Health System on 2021-11-12.