Bupivacaine/Epinephrine +Dexamethasone vs. Liposomal Bupivacaine

Part of paid clinical trials in Camden, New Jersey.

Sponsor
The Cooper Health System
Study ID
NCT03906617
Phase
PHASE4
Status
Recruiting

Conditions

  • Robotic Lung Surgery

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Intercostal nerve block and wound infiltration with liposomal bupivacaine — DRUG
    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 — DRUG
    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.

Study Details

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.

Key Dates

Start date
Apr 10, 2019
Status verified
Nov 2021
Primary completion
Apr 10, 2022
Completion
Jun 10, 2022

Study Design

Enrollment
34 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Bupivacaine/epinephrine + dexamethasone
  • Active Comparator: Liposomal bupivacaine

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cooper University HospitalCamdenNew Jersey08103
Noud van Helmond, MD
856-968-7336

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