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Liposomal Bupivacaine Versus Plain Bupivacaine After Intercostal Injections For Pain Management After Thoracoscopy

RecruitingPhase 4Ages 18 Years - anyAllMilton S. Hershey Medical Center
NCT03737292 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Exparel
  • Bupivacaine
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Where

1 site
Milton S. Hershey Medical Center
Hershey, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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