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

• Status: Recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Milton S. Hershey Medical Center
• Treatments: Bupivacaine

Criteria

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