Operative Intercostal Nerve Blocks With Long-Acting Bupivacaine Liposome for Pain Control After Thoracotomy.
Kamal G Khalil, Mina L Boutrous, Adel D Irani...
https://pubmed.ncbi.nlm.nih.gov/26507422/Actively Recruiting
Led by Milton S. Hershey Medical Center · Updated on 2026-06-12
40
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating the pharmacokinetics of liposomal bupivacaine Exparel compared with plain bupivacaine after multilevel intercostal injections during minimally invasive thoracic surgeries. The study aims to assess plasma levels of bupivacaine after injections to ensure safety by remaining below toxic thresholds and to see if liposomal bupivacaine reduces opioid use and pain up to three months post-surgery. Secondary outcomes include rates of pneumonia, atrial fibrillation, and hospital stay length, which may be influenced by postoperative pain and inflammation. Participants receive either intercostal injections of 266 mg liposomal bupivacaine diluted to 30 ml or intercostal injections of 0.5% plain bupivacaine at 2 mgkg dose diluted to 30 ml. Injections target several intercostal spaces corresponding to surgical sites and adjacent levels. The study compares the plasma concentration profiles of both drugs after administration to evaluate safety and pharmacokinetics. During the study, researchers measure plasma bupivacaine levels at multiple time points from 0.5 to 72 hours after surgery. Participants are monitored for opioid consumption, pain levels, and complications such as pneumonia and atrial fibrillation. The study collects safety and outcome data throughout the postoperative period to understand both acute and chronic pain management effects, with the trial expected to complete by December 2026.
CONDITIONS
Liposomal Bupivacaine Versus Plain Bupivacaine After Intercostal Injections For Pain Management After Thoracoscopy
Z
Zoulfira Nisnevitch-Savarese, MD
C
Christopher Cowart, MD
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Milton S. Hershey Medical Center
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Exparel intercostal block | Plain bupivacaine intercostal block | No intercostal block |
|---|---|---|---|
| What it is | An intercostal nerve block using liposomal bupivacaine (Exparel) administered at multiple levels around thoracoscopic incisions | An intercostal nerve block using plain bupivacaine (0.5 % at 2 mg/kg diluted to 30 ml) administered at similar multiple thoracoscopic incision levels | Usual postoperative pain management without intercostal nerve block |
| Role in trial | Investigational arm randomized to receive liposomal bupivacaine block | Active comparator randomized arm receiving plain bupivacaine block | Not included in trial but a common practice when regional analgesia is omitted |
| Primary use | Postoperative pain relief via prolonged‑release block after thoracoscopic surgery | Postoperative pain relief via single‑release block after thoracoscopic surgery | Analgesia using systemic and other non‑regional methods |
| How it is given or performed | Intercostal injections of Exparel into approximately 5‑6 spaces surrounding the incision and chest tube sites | Intercostal injections of 0.5 % plain bupivacaine (2 mg/kg diluted to 30 ml) into similar intercostal spaces | Not applicable; no block performed |
| Evidence status | Associated with shorter hospital stay and earlier ambulation compared to plain bupivacaine, though opioid use did not differ | Serves as comparator; less effect on length of stay and ambulation compared to liposomal formulation | Not evaluated directly in trial; general practice suggests slower ambulation and longer stay without regional block |
| Important risks | Not fully characterized; safety profile not detailed in trial registry | Known local anesthetic risks apply; trial registry does not detail specific risks | Avoids regional block risks but does not reflect risks of systemic analgesics admitted separately |
| Important limitations | Pain difference small; opioid use similar; evidence from small study; generalizability limited | Standard comparator shows less benefit; same generalizability concerns apply | Not studied directly here; speculation based on typical outcomes without regional analgesia |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single-day procedure during surgery
Participants receive intercostal injections of either liposomal bupivacaine or plain bupivacaine during minimally invasive thoracic surgery.
Surgical procedure visit
Duration - Up to 3 months
Participants are monitored for plasma drug levels, pain control, opioid use, and postoperative complications for up to 3 months after surgery.
Multiple assessments including blood tests and pain evaluations
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Lead Sponsor