Pre-incisional Infiltration With Ropivacaine Plus Triamcinolone for Relieving Postoperative Pain After Thoracoscopic Surgery

Официальное название

The Efficacy and Safety of Pre-incisional Infiltration With Ropivacaine Plus Triamcinolone in Patients Undergoing Video-assisted Thoracoscopic: a Multi-center Randomized Controlled Trial.

Обзор

Video-assisted thoracoscopic surgery (VATS) is less invasive compared to traditional thoracotomy, but it is still 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. Acute pain after VATS is mainly caused by the release of inflammatory mediators after soft tissue injury at the surgical site, which activates peripheral pain receptors and leads to abnormal action potentials transmitted along A δ and C fibers. Inflammatory mediators released from the soft tissues around incisions not only significantly alters the chemical microenvironment at the peripheral terminals of nociceptors, directly inducing pain, but also sensitizes afferent fibers, contributing to peripheral sensitization. Incisional infiltration is the simplest, safest, and most effective anesthesia method for preventing incision pain after laparoscopic surgery but even using long-acting local anesthetics, the effectiveness of postoperative analgesia can only last for a relatively short period of time. To improve the efficiency of local incision infiltration in postoperative analgesia, at least two issues need to be addressed: prolonging the duration of analgesia and reducing inflammation of nerve surrounding tissues. Numerous studies have shown that glucocorticoids not only can achieve anti-inflammatory and analgesic effects by inhibiting inflammatory cytokines and inflammatory responses but also can prolong the duration of action of local anesthetics. The investigators conducted a multicenter, prospective, randomized controlled clinical study to explore whether preemptive incisional infiltration with ropivacaine plus triamcinolone is superior to ropivacaine alone in relieving postoperative pain for adults undergoing VATS. The investigators also compare the effects of the two intervention measures on postoperative pain management, patient safety, and recovery quality.

Вмешательства

• Препарат Pre-incisional infiltration with ropivacaine plus triamcinolone
  Before the surgery, according to the surgeon's incision marking, the patients accept 2ml of triamcinolone (80mg) plus 15ml of 1% ropivacaine diluted with 0.9% saline to a total volume of 30ml infiltrates the incision layer by layer (1ml subcutaneous infiltration at each location, 2ml full layer infiltration, total 3ml).
• Препарат Pre-incisional infiltration with ropivacaine alone
  Before the surgery, according to the surgeon's incision marking, the patients accept 30ml of 0.5% ropivacaine infiltrates the incision layer by layer (1ml subcutaneous infiltration at each location, 2ml full layer infiltration, total 3ml).

Первичные конечные точки

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

Вторичные конечные точки (7)

• Area Under the Curve (AUC) of Numeric Rating Scale at rest (NRSr) Within 0-72 Hours Postoperatively [Срок оценки: Time Frame: Data will be collected at 4、12、24、36 and 72 hours postoperatively]
• Area under the curve (AUC) of the Numerical Rating Scale during movement (NRSm) within 0-72 hours postoperatively [Срок оценки: Data will be collected at 4、12、24、36 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.]
• Patient Satisfaction Scale(PSS) [Срок оценки: Postoperative hours 4、12、24 and 48 hours]
• Postoperative nausea and vomiting (PONV) [Срок оценки: Postoperatively within 48 hours.]
• wound healing score at 72 h, 1 and 3 months postoperatively and patient and observer scar assessment scale (POSAS) at 72 h, 1 and 3 months. [Срок оценки: Postoperative 72 hours、1 and 3 months.]
• Adverse events [Срок оценки: Within 72 hours postoperatively]

Критерии участия

Критерии включения

• Patients scheduled for elective thoracoscopic wedge resection, segmentectomy, and lobectomy under general anesthesia;
• Ages 18 to 64 years old
• American Society of Anesthesiologists (ASA) physical status of I-III
• Patients must be able to understand nature and potential personal consequences of the clinical trial and cooperation with follow-up investigations
• signing of the informed consent form.

Критерии исключения

• History of allergies to experimental drugs such as opioids or steroids;
• Alcohol abuse; Long term use of opioid drugs (exceeding 2 weeks or 3 days per week for more than 1 month); Suspected use of sedatives and analgesics; Use analgesic drugs within 24 hours before surgery; Patients undergoing steroid therapy;
• Serious neurological disorders, severe liver and kidney dysfunction, heart failure, etc;
• Unable to use pain assessment scale;
• Pregnant or lactating patients.

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

Идентификаторы

NCT: NCT07603921 · KY2025-338-02-4

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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