Ropivacaine-Poloxamer 407 Gel for Pain Control After Open Gastrectomy

Официальное название

Prospective Randomized Controlled Trial of Ropivacaine-Poloxamer 407 Based Gel Application on Postoperative Pain After Open Gastrectomy

Обзор

The study evaluates the efficacy of Ropivacaine-Poloxamer 407 hydrogel in reducing postoperative pain following open gastrectomy.

Вмешательства

• Процедура Arm I (Peritoneal application group)
  At the end of gastrectomy, during closure of incision, peritoneum and fascia are closed by suture, layer by layer. Skin approximation is doen with skin stapler. Ropivacaine-Poloxamer 407 hydrogel is applied on space between peritoneum and fascia in Arm I.
• Процедура Arm II (Subcutaneous injection group)
  At the end of gastrectomy, during closure of incision, peritoneum and fascia are closed by suture, layer by layer. Skin approximation is doen with skin stapler. Ropivacaine-Poloxamer 407 hydrogel is injected on subcutaneous area in Arm II.

Первичные конечные точки

• Total fentanyl consumption within 72 hours postoperatively. [Срок оценки: Total fentanyl consumption within 72 hours postoperatively.]

Вторичные конечные точки (6)

• Pain intensity scores (NRS) at rest and during movement. [Срок оценки: Pain intensity: Measured at 24, 48, and 72 hours postoperatively.]
• Time to first flatus and bowel movement. [Срок оценки: Bowel function: Time to first flatus and bowel movement recorded until discahrge (within 6 days)]
• Occurrence of postoperative nausea and vomiting (PONV). [Срок оценки: PONV: Assessed daily for 72 hours.]
• Wound healing assessment, including seroma and infection rates. [Срок оценки: Wound healing: Evaluated at regular intervals until first outpatient day (within 14 days)]
• Length of hospital stay. [Срок оценки: Hospital stay: up to 1 month]
• Quality of recovery (QoR-15). [Срок оценки: QoR-15: Measured at baseline and 72 hours postoperatively.]

Критерии участия

Критерии включения

• Patients with a histologically confirmed diagnosis of gastric adenocarcinoma prior to surgery.
• Patients who have undergone a complete surgical resection (R0 resection).
• Patients with an ASA (American Society of Anesthesiologists) score of 3 or below.
• Patients aged 20 years or older.

Критерии исключения

• Patients under 19 years of age.
• Presence of ascites or peritoneal metastasis.
• Patients who have undergone preoperative chemotherapy or radiotherapy.
• Diagnosis of malignancies other than gastric cancer.
• Uncontrolled diabetes, autoimmune diseases, hypertrophic scars, or keloid history affecting wound healing.
• History of allergy or adverse reactions to Ropivacaine or other local anesthetics.
• Pregnant women.
• Patients with preoperative chronic pain conditions, including CRPS.
• Patients with long-term preoperative use of opioid analgesics.
• Patients with psychiatric disorders deemed likely to interfere with study participation.
• Patients with severe liver disease, renal disease, or arrhythmia.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• GangnamSeverance Hospital — Seoul

Идентификаторы

NCT: NCT06778954 · 3-2024-0383

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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