Comparing liposomal bupivacaine and plain bupivacaine for pain management after thoracoscopic surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the pharmacokinetics of liposomal bupivacaine (Exparel) compared to plain bupivacaine after intercostal injections for pain control during and after thoracoscopic surgeries. It aims to assess plasma concentrations of bupivacaine following the administration of 266 mg of liposomal bupivacaine versus 2 mg/kg of plain bupivacaine, ensuring that levels remain below toxic thresholds. The study also investigates the safety profile of liposomal bupivacaine in this context, as its use in intercostal injections has not been extensively studied. By analyzing these parameters, the research seeks to provide insights into the efficacy and safety of this newer formulation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1\. Male or female patients over age 18 undergoing minimally invasive thoracic surgeries including but not limited to:

1. VATS wedge resection /segmentectomy
2. VATS lobectomy.
3. Robot assisted thoracoscopic wedge resection/segmentectomy.
4. Robot assisted thoracoscopic lobectomy procedures.

Exclusion Criteria:

1. Patients under18 years of age
2. Patients weighing less than 48 kg
3. Pregnant and lactating females will be excluded from the trial
4. Patients preoperatively taking narcotics for chronic pain in proximity to surgical site
5. Patients with previous ipsilateral thoracic surgery
6. Patients undergoing pleurectomy/mechanical pleurodesis.
7. Patients with high likelihood of conversion from thoracoscopic procedure to open thoracotomy as determined by an operating surgeon
8. Patients with pre-existing painful conditions (CRIPS, fibromyalgia, neuropathy)
9. Patients unable to reliably communicate pain scores such as patients with dementia, alterations in mental status
10. Patients with hypersensitivity to local anesthetics and pain medications used in the study
11. Patients with previous thoracic spine surgeries
12. Patients with increased creatinine (over 1.5mg/dl)
13. Patients with liver dysfunction
14. Non-English speaking patients

Where it's running

• Milton S. Hershey Medical Center
  Hershey, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Zoulfira Nisnevitch-Savarese, MD — Penn State Hershey College of Medicine
• Study coordinator: Zoulfira Nisnevitch-Savarese, MD
• Email: znisnevitchsavarese@pennstatehealth.psu.edu
• Phone: 717-531-4264

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.