Liposomal Bupivacaine Versus Plain Bupivacaine After Intercostal Injections For Pain Management After Thoracoscopy
Status:
Recruiting
Trial end date:
2023-10-01
Target enrollment:
Participant gender:
Summary
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.