RecruitingNot ApplicableNCT07441902

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


Sponsor

Beijing Tiantan Hospital

Enrollment

134 participants

Start Date

Mar 2, 2026

Study Type

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

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Bupivacaine hydrochloride and a drug called Liposomal bupivacaine plus bupivacaine for people with liposomal bupivacaine, pain management, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 64 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGBupivacaine hydrochloride

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.

DRUGLiposomal bupivacaine plus bupivacaine

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)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07441902


Related Trials