Bupivacaine/Epinephrine +Dexamethasone vs. Liposomal Bupivacaine
ConditionRobotic Lung Surgery
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-90
SponsorThe Cooper Health System
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
undergoing robotic wedge resection or lobectomy for lung mass(es)
Disqualifiers
emergency case
history of opiate abuse
chronic pain syndrome
intravenous drug use
Trial design
Design model
Parallel
Treatments tested in this trial
Intercostal nerve block and wound infiltration with liposomal bupivacaine
DrugIntercostal 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
DrugIntercostal 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.
Treatment groups
34 Participants
are divided into 2 treatment groupsGroup A: Bupivacaine/epinephrine + dexamethasoneExperimental treatment 1 intervention
Group B: Liposomal bupivacaineActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Visual Analogue Scale pain scores
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.
Time frame
24 hours post-surgerySponsors and contacts
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Source ClinicalTrials.gov