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

Официальное название

The Efficacy and Safety of Pre-incisional Infiltration With Ropivacaine Plus Triamcinolone for Postoperative Pain in Patients Undergoing Laparoscopic Surgery: a Multi-center Randomized Controlled Trial.

Обзор

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. Studies have shown that up to 80% of patients experience postoperative pain following laparoscopic surgery due to inflammation caused by surgical incisions and surrounding tissues, necessitating pharmacological relief. Inflammatory mediators released from the soft tissues around laparoscopic 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. Preemptive incisional infiltration using local anesthetics with corticosteroids which have potent local anti-inflammatory properties may play a key role in preventing or reducing postoperative pain. The objective of this trial is to determine whether preemptive incisional infiltration with ropivacaine plus triamcinolone is superior to ropivacaine alone in relieving postoperative pain for adults undergoing laparoscopic surgery. We 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 (8)

• Area Under the Curve (AUC) of Numeric Rating Scale at rest (NRSr) Within 0-72 Hours Postoperatively [Срок оценки: 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 [Срок оценки: Postoperative 72hours、1 and 3 months.]
• Adverse events [Срок оценки: Within 72 hours postoperatively]
• postoperatively and patient and observer scar assessment scale [Срок оценки: Postoperative 72 hours、1 and 3 months]

Критерии участия

Критерии включения

• Patients scheduled for elective Laparoscopic Surgery for laparoscopic cholecystectomy, appendectomy, or hernia repair 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

Последовательный дизайн

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Beijing Tiantan Hospital — Пекин

Идентификаторы

NCT: NCT07591233 · KY2025-338-02-3

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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