Evaluation of the toxicity of local anaesthetic agents in man.
D B Scott
https://pubmed.ncbi.nlm.nih.gov/1096908Actively Recruiting
Phase 4
Age: 18Years +
All Genders
ID03737292
Comparison of Plasma Concentration and Efficacy of Liposomal Bupivacaine and Plain Bupivacaine After Intercostal Injections for Pain Management After Thoracoscopy
Led by Milton S. Hershey Medical Center · Updated on 2025-06-04
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the pharmacokinetics and safety of liposomal bupivacaine (Exparel) compared to plain bupivacaine for pain control during and after minimally invasive thoracic surgeries. This study aims to measure plasma concentrations of bupivacaine after intercostal injections and assess if the levels stay below toxic thresholds. Additionally, it explores whether liposomal bupivacaine reduces opioid use, postoperative pain, and complications such as pneumonia and atrial fibrillation, potentially improving recovery and hospital stay length. Participants receive either 266 mg of liposomal bupivacaine diluted to 30 ml or 0.5% plain bupivacaine at 2 mg/kg diluted to 30 ml. The injections target multiple intercostal spaces around incision and chest tube sites. The study is randomized and triple-blinded, comparing the two drug formulations during the thoracoscopic procedures. During the study, blood samples are taken at multiple time points up to 72 hours post-injection to measure bupivacaine levels. Researchers will monitor opioid consumption, pain scores, rates of pneumonia, atrial fibrillation, and hospital stay duration over 48 hours and up to 3 months. Participant safety is closely observed, with the total involvement lasting several months to capture both acute and chronic pain outcomes.
CONDITIONS
Brief Title
Liposomal Bupivacaine Versus Plain Bupivacaine After Intercostal Injections For Pain Management After Thoracoscopy
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Male or female patients over age 18 undergoing minimally invasive thoracic surgeries including VATS wedge resection, segmentectomy, lobectomy, and robot-assisted thoracoscopic procedures
You will not qualify if you...
- Patients under 18 years of age
- Patients weighing less than 48 kg
- Pregnant and lactating females
- Patients taking narcotics for chronic pain near the surgical site
- Patients with previous surgery on the same side of the chest
- Patients undergoing pleurectomy or mechanical pleurodesis
- Patients likely to require conversion to open thoracotomy
- Patients with pre-existing painful conditions such as CRIPS, fibromyalgia, or neuropathy
- Patients unable to reliably communicate pain scores
- Patients with hypersensitivity to local anesthetics or study pain medications
- Patients with previous thoracic spine surgeries
- Patients with elevated creatinine over 1.5 mg/dl
- Patients with liver dysfunction
- Non-English speaking patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single administration during surgery with monitoring up to 72 hours post-injection
Participants receive intercostal injections of either liposomal bupivacaine (Exparel) or plain bupivacaine during minimally invasive thoracic surgery to manage pain.
Monitoring visits at 0.5, 1, 2, 4, 8, 12, 24, 32, 48, and 72 hours after injection
Trial Site Locations
Total: 1 location
1
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
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Research Team
Z
Zoulfira Nisnevitch-Savarese, MD
C
Christopher Cowart, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/9175963The Third American Society of Regional Anesthesia and Pain Medicine Practice Advisory on Local Anesthetic Systemic Toxicity: Executive Summary 2017.
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Kamal G Khalil, Mina L Boutrous, Adel D Irani...
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