The Efficacy and Safety of Liposomal Bupivacaine for Rhomboid Intercostal Nerve Block in Relieving Postoperative Pain After Video-assisted Thoracoscopic Surgery
Ultrasound-Guided Liposomal Bupivacaine Plus Bupivacaine Rhomboid Intercostal Block for Postoperative Pain Relief in Patients Undergoing Thoracoscopic Surgery:A Multi-Center Randomized Controlled Trial
Beijing Tiantan Hospital
134 participants
Mar 2, 2026
INTERVENTIONAL
Conditions
Summary
Video-assisted thoracoscopic surgery (VATS) is less invasive compared to traditional thoracotomy. It is reported that the incidence of acute pain following VATS exceeds 80%. Inadequate postoperative analgesia may trigger a series of adverse physiological stress responses, increase the occurrence of postoperative complications, and affect the rehabilitation process.If acute pain is not managed promptly and sufficiently, nearly one-quarter of patients may develop chronic pain, impacting normal life and sleep quality after discharge.In recent years, multimodal postoperative analgesia protocols have been increasingly adopted in clinical practice. The Rhomboid intercostal block (RIB), as a novel regional anesthesia technique within the multimodal analgesia framework, has been widely utilized in various thoracic surgical procedures. Liposomal bupivacaine, an innovative long-acting sustained-release amide local anesthetic, provides prolonged analgesia for up to 72 hours. However, its efficacy and safety in video-assisted thoracoscopic surgery (VATS) have not yet been fully validated. Based on this premise, the present study aims to evaluate and compare the clinical outcomes of ultrasound-guided Rhomboid intercostal block (RIB) utilizing liposomal bupivacaine combined with conventional bupivacaine for postoperative pain management in patients undergoing VATS.
Eligibility
Inclusion Criteria5
- Patients scheduled for elective video-assisted thoracoscopic lobectomy or wedge resection under general anesthesia;
- Ages 18 to 64 years old；
- American Society of Anesthesiologists (ASA) physical status of I-III；
- Glasgow Coma Scale (GCS) score of 15；
- Patients must be able to understand the nature and potential personal consequences of the clinical trial, signing of the informed consent form.
Exclusion Criteria14
- History of chronic pain syndrome of any cause.
- Patients with heart conduction block (sinus block or atrioventricular block).
- Patients with unstable coronary artery disease.
- Patients with gastric ulcer or gastric bleeding.
- Patients with diabetes and are being treated with insulin.
- Subjects with coagulation dysfunction (prothrombin time or activated partial thromboplastin time is higher than the normal threshold) or patients who are taking oral anticoagulants for other medical reasons and have not stopped it before surgery, such as warfarin or new anticoagulants rivaroxaban or dabigatran.
- Patients with abnormal liver function: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \> 2× the upper limit of normal (ULN) or total bilirubin (TBIL) ≥ 1.5×ULN.
- Patients with renal impairment (serum creatinine \> 176 µmol/L) or receiving dialysis treatment within 28 days before surgery.
- Patients with a history of diagnosed mental illness or currently taking psychotropic medication.
- Excessive alcohol or drug abuse, chronic opioid use (more than 2 weeks or 3 days per week for more than 1 month), use of drugs with confirmed or suspected sedative or analgesic effects, or use of any painkiller within 24 h before surgery.
- Pregnancy or breastfeeding.
- Extreme body mass index (BMI) (\< 15 or \> 35).
- Participation in another interventional trial that interferes with the intervention or outcome of this trial.
- Patients with a history of allergy to local anaesthetics or one of the study drugs.
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Interventions
Prior to surgical incision, the Doppler ultrasound-guided injection technique will be employed. A 22-gauge block needle will be inserted at the medial border of the scapula at the T5-T6 vertebral level using an in-plane approach. Upon reaching the rhomboid-intercostal fascial plane, 20 mL of 0.25% bupivacaine will be administered. The patient-controlled analgesia (PCA) pump solution consists of 100 μg sufentanil and 16 mg ondansetron diluted with normal saline to a total volume of 100 mL. Postoperatively, patients may self-administer a 2-mL bolus per demand, with a lockout interval of 10 minutes. Should analgesia remain inadequate after four consecutive boluses, one tablet of oxycodone-acetaminophen(containing 5 mg oxycodone hydrochloride and 325 mg acetaminophen) may be administered orally, with a minimum repeat dosing interval of 6 hours. For persistent pain, intravenous morphine 5 mg may be administered at intervals no shorter than 4 hours.
Prior to surgical incision, the Doppler ultrasound-guided injection technique will be employed. A 22-gauge block needle will be inserted at the medial border of the scapula at the T5-T6 vertebral level using an in-plane approach. Upon reaching the rhomboid-intercostal fascial plane, 20 mL of a mixed solution-comprising 10 mL of liposomal bupivacaine (133 mg) and 10 mL of 0.25% bupivacaine diluted in normal saline-will be administered. The patient-controlled analgesia (PCA) pump solution consists of 100 μg sufentanil and 16 mg ondansetron diluted with normal saline to a total volume of 100 mL. Postoperatively, patients may self-administer a 2-mL bolus per demand, with a lockout interval of 10 minutes. Should analgesia remain inadequate after four consecutive boluses, one tablet of oxycodone-acetaminophen may be administered orally, with a minimum repeat dosing interval of 6 hours. For persistent pain, intravenous morphine 5 mg may be administered at intervals no shorter than 4 hours.
Locations(1)
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NCT07441902