Actively Recruiting
Liposomal Bupivacaine Versus 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
390 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to assess pharmacokinetics of liposomal bupivacaine (Exparel) after multilevel intercostal injections of this local anesthetic for pain control during and after thoracoscopic surgeries. The specific aim of this study is to evaluate plasma concentration of bupivacaine after intraoperative intercostal injections of 266 mg of liposomal bupivacaine and compare it to plasma concentrations of bupivacaine after intercostal injections of 2mg/kg of 0.5% plain Bupivacaine with maximal dose of 30 ml or 150 mg. The hypothesis of the study is that plasma concentration of bupivacaine after intercostal injections of 266 mg of liposomal bupivacaine will be similar to concentrations after injections of plain bupivacaine, and will remain below the toxic level threshold range of 2000-3000 ng/mL (2-3 mg/L) at which central nervous system and cardiovascular adverse events would be expected to occur. The secondary objective is to evaluate if intercostal injections of 266 mg of liposomal bupivacaine will significantly reduce opioid consumption and postsurgical pain, within the first 48 hours and up to 3 months after minimally invasive thoracic surgeries, to determine if both acute and chronic post-thoracotomy pain can be decreased by intraoperative intercostal injections of liposomal bupivacaine. Additionally, the rate of pneumonia, the rate of atrial fibrillation and length of hospital stay will be assessed as secondary outcomes after thoracic surgeries. These outcomes can be affected by the level of postoperative pain and inflammation. Significance of this study: If positive, the results of this research have the potential to significantly improve pain management after thoracoscopic surgery. Based on prior experience, prolonged analgesia after liposomal bupivacaine injection is safe, and may help reduce perioperative opioid consumption and decrease opioid related complications. It will improve patient comfort, eliminate need for indwelling neuraxial catheters and risks associated with them.
CONDITIONS
Official Title
Liposomal Bupivacaine Versus Plain Bupivacaine After Intercostal Injections For Pain Management After Thoracoscopy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients over age 18 undergoing minimally invasive thoracic surgeries including VATS wedge resection/segmentectomy, VATS lobectomy, robot-assisted thoracoscopic wedge resection/segmentectomy, or robot-assisted thoracoscopic lobectomy 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 ipsilateral thoracic surgery
- Patients undergoing pleurectomy or mechanical pleurodesis
- Patients likely to convert from thoracoscopic procedure to open thoracotomy
- Patients with pre-existing painful conditions such as CRIPS, fibromyalgia, or neuropathy
- Patients unable to reliably communicate pain scores, including those with dementia or altered mental status
- Patients with hypersensitivity to local anesthetics or study pain medications
- Patients with previous thoracic spine surgeries
- Patients with elevated creatinine levels over 1.5 mg/dl
- Patients with liver dysfunction
- Non-English speaking patients
AI-Screening
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Trial Site Locations
Total: 1 location
1
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
Research Team
Z
Zoulfira Nisnevitch-Savarese, MD
CONTACT
C
Christopher Cowart, MD
CONTACT
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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