Actively Recruiting
Liposomal Bupivacaine Versus Bupivacaine And Dexamethasone Intercostal Nerve Blocks For Robotic Thoracic Surgery: A Prospective Randomized Single-Blinded Clinical Trial
Led by The Cooper Health System · Updated on 2021-11-12
34
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating pain control methods following robotic lung surgery. This prospective randomized single-blinded clinical trial compares two approaches: wound infiltration and intercostal nerve block using either liposomal bupivacaine or a combination of bupivacaine/epinephrine plus dexamethasone. Liposomal bupivacaine is a newer local anesthetic that has not yet been compared to the established bupivacaine/epinephrine plus dexamethasone combination in this surgical context. Participants will be randomly assigned to one of two groups. One group will receive an intercostal nerve block and wound infiltration with 266 mg of liposomal bupivacaine combined with 24 ml of 0.5% bupivacaine. The other group will receive intercostal nerve block and wound infiltration with 42 ml of 0.5% bupivacaine/epinephrine plus 8 mg dexamethasone during their robotic lung resection surgery. During the study, participants' pain levels will be assessed using the Visual Analogue Scale 24 hours after surgery. Researchers will monitor and compare pain control effectiveness between the two treatments. The trial is led by The Cooper Health System and includes adults aged 18 to 90 undergoing robotic wedge resection or lobectomy for lung masses. The study's design includes randomized allocation and double masking to ensure unbiased results.
CONDITIONS
Brief Title
Bupivacaine/Epinephrine +Dexamethasone vs. Liposomal Bupivacaine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Undergoing robotic wedge resection or lobectomy for lung mass(es)
- Age between 18 and 90 years
You will not qualify if you...
- 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 unable to rate pain on a visual analogue scale
- History of allergic reaction to bupivacaine, liposomal bupivacaine, or dexamethasone
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo robotic lung surgery with either liposomal bupivacaine or bupivacaine/epinephrine plus dexamethasone intercostal nerve blocks and wound infiltration.
1 surgical procedure visit (in-person)
Duration - 24 hours post-surgery
Participants are monitored for pain and recovery after surgery.
1 follow-up visit approximately 24 hours after surgery
Trial Site Locations
Total: 1 location
1
Cooper University Hospital
Camden, New Jersey, United States, 08103
Actively Recruiting
Research Team
N
Noud van Helmond, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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