The Efficacy and Safety of Liposomal Bupivacaine in Relieving Postoperative Pain After Video-assisted Thoracoscopic Surgery

Официальное название

The Efficacy and Safety of Liposomal Bupivacaine Plus Bupivacaine Local Incisional Infiltration for Postoperative Pain in Patients Undergoing Video-assisted Thoracoscopic Surgery:A Multi-Center Randomized Controlled Trial

Обзор

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. Local infiltration anesthesia at the incision site is one of the simplest, safest, and most effective methods for preventing postoperative incision pain. Liposomal bupivacaine(LB) is a novel, long-acting, sustained-release amide-type local anesthetic, providing localized analgesic effects for up to 72 hours. Some researchers have reported the analgesic effects of LB VS traditional local anesthetics infiltration, but the current research results are highly heterogeneous. More prospective studies are needed to evaluate whether LB infiltration is superior to the traditional local anesthetics for the management of postoperative pain. The investigators designed this study to compare the analgesic effect of using LB plus bupivacaine for local infiltration with bupivacaine along for patients after VATS.

Вмешательства

• Препарат Bupivacaine hydrochloride
  The 40 mL 0.25% Bupivacaine hydrochloride (100 mg, normal saline dilution) for the Bupivacaine hydrochloride group.Local infiltration will be performed by the thoracic surgeon before closure. A total of 30-40 mL of fluid will be injected at the incision.The PCA solution is prepared by diluting 100 μg of sufentanil and 16 mg of ondansetron with normal saline to a total volume of 100 mL. Postoperatively, the patient may press the demand button for analgesia. Each activation delivers a 2 mL bolus,
• Препарат Liposomal bupivacaine plus bupivacaine
  The 20 mL (266 mg) of liposomal bupivacaine will be mixed with a volume of 20 mL 0.25% Bupivacaine hydrochloride (50 mg, normal saline dilution) for the Liposomal Bupivacaine plus Bupivacaine hydrochloride group.Local infiltration will be performed by the thoracic surgeon before closure.A total of 30-40 mL of fluid will be injected at the incision.The PCA solution is prepared by diluting 100 μg of sufentanil and 16 mg of ondansetron with normal saline to a total volume of 100 mL. Postoperatively

Первичные конечные точки

• Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively [Срок оценки: The postoperative period 48 hours.]

Вторичные конечные точки (12)

• Area Under the Curve (AUC) of Numeric Rating Scale at rest (NRSr) Within 0-72 Hours Postoperatively [Срок оценки: Data will be collected at 2 hours, 24 hours, 48 hours, and 72 hours postoperatively.]
• Numeric Rating Scale at rest (NRSr) at 1 week, 1 month, and 3 months postoperatively [Срок оценки: Postoperative day 7, month 1, and month 3.]
• Time to request of first analgesia [Срок оценки: Within 48 hours postoperatively.]
• Cumulative sufentanil dose for four separate periods (0-4, 4-8, 8-24, and 24-48 h), a total press count including both valid and invalid presses [Срок оценки: Postoperative Hours 4, 8, 24, and 48.]
• Duration days of Oral Oxycodone and Acetaminophen Tablets Administration [Срок оценки: Within 3 months postoperatively.]
• Patient Satisfaction Scale，PSS [Срок оценки: Postoperative hours 2, 24, 48, and 72; week 1; month 1; and month 3.]
• Ramsay Sedation Scale，RSS [Срок оценки: Postoperative at 2 hours, 24 hours, 48 hours, and 72 hours.]
• Quality of Recovery-40，QoR-40 [Срок оценки: Postoperative hours 24, 48, and 72.]
• The length of stay in the post-anesthesia care unit（PACU） [Срок оценки: The time from the end of surgery until transferred back to the ward.Typically, patients are transferred back to the ward after approximately 30 to 60 minute.]
• Length of Stay (LOS) [Срок оценки: Perioperation.]
• Total hospitalization expenses incurred during the patient's inpatient stay [Срок оценки: Perioperation.]
• Postoperative nausea and vomiting，PONV [Срок оценки: Postoperatively within 72 hours.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Beijing Tiantan Hospital — Пекин

Публикации

• Zhao HX, Dou W, Meng XT, Shi YF, Shan XS, Ji FH, Chen SM, Peng K. Liposomal bupivacaine vs. Ropivacaine for wound infiltration on chronic postsurgical pain after video-assisted thoracoscopic lung surgery: protocol for a randomized, double-blind, controlled trial. Ann Med. 2025 Dec;57(1):2543522. doi: 10.1080/07853890.2025.2543522. Epub 2025 Aug 4. PMID 40760826
• Dikici M, Akesen S, Yavascaoglu B, Bayram AS, Kaya FN, Gurbet A. Comparison of intraoperative and post-operative effects of serratus anterior plane block performed with ultrasound and infiltration block in patients undergoing video-assisted thoracoscopic surgery. Agri. 2022 Jan;34(1):23-32. doi: 10.14744/agri.2021.22605. PMID 34988957

Идентификаторы

NCT: NCT07432711 · KY2025-289-02-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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