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Recruiting NCT07441902

NCT07441902 The Efficacy and Safety of Liposomal Bupivacaine for Rhomboid Intercostal Nerve Block in Relieving Postoperative Pain After Video-assisted Thoracoscopic Surgery

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Clinical Trial Summary
NCT ID NCT07441902
Status Recruiting
Phase
Sponsor Beijing Tiantan Hospital
Condition Video-assisted Thoracoscopic Surgery (VATS)
Study Type INTERVENTIONAL
Enrollment 134 participants
Start Date 2026-03-02
Primary Completion 2027-03-30

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 64 Years
Study Type INTERVENTIONAL
Interventions
Bupivacaine hydrochlorideLiposomal bupivacaine plus bupivacaine

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 134 participants in total. It began in 2026-03-02 with a primary completion date of 2027-03-30.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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 Criteria

Inclusion Criteria: * 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 Criteria: * 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.

Contact & Investigator

Central Contact

Fang Luo

✉ 13611326978@163.com

📞 +86 13611326978

Principal Investigator

Fang Luo

PRINCIPAL INVESTIGATOR

Beijing Tiantan Hospital

Frequently Asked Questions

Who can join the NCT07441902 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 64 Years, studying Video-assisted Thoracoscopic Surgery (VATS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07441902 currently recruiting?

Yes, NCT07441902 is actively recruiting participants. Contact the research team at 13611326978@163.com for enrollment information.

Where is the NCT07441902 trial being conducted?

This trial is being conducted at Beijing, China.

Who is sponsoring the NCT07441902 clinical trial?

NCT07441902 is sponsored by Beijing Tiantan Hospital. The principal investigator is Fang Luo at Beijing Tiantan Hospital. The trial plans to enroll 134 participants.

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