Intrathecal Morphine Injection Versus Continuous Wound Infiltration After Pancreaticoduodenectomy

Официальное название

Effect of Single-Shot Intrathecal Morphine Injection Versus Continuous Wound Infiltration on Postoperative Pain After Pancreaticoduodenectomy: a Prospective, Open-Label, Randomized Controlled, Non-Inferiority Trial

Обзор

This is a prospective randomized open-label noninferiority trial that compares intrathecal morphine injection and continuous wound infiltration after open pancreaticoduodenectomy.

Подробное описание

Open pancreaticoduodenectomy causes severe postoperative pain due to the relatively large incision and tissue damage compared to other abdominal surgeries. Current Enhanced Recovery After Surgery (ERAS) guidelines recommend continuous wound infiltration for pancreaticoduodenectomy as an effective analgesic modality along with thoracic epidural analgesia. However, continuous wound infiltration is effective for somatic pain in the abdominal wall but not for visceral pain from the incision of internal organs. It also requires the placement of a catheter for several days after surgery, which can be inconvenient for patients.

Intrathecal morphine injection has been recommended as an effective analgesic method for abdominal surgery because they provide potent, long-lasting analgesia with a single injection and can provide equivalent analgesia with a much smaller dose compared to intravenous or oral morphine. Several previous studies have reported on the analgesic efficacy of a single intrathecal morphine injection including pancreaticoduodenectomy. However, no studies have compared a single intrathecal morphine injection with continuous wound infiltration for pancreaticoduodenectomy. To date, studies comparing the two methods of analgesia have only been reported in cesarean section and donor hepatectomy, and these studies either found no significant difference between the two methods of analgesia or reported that intrathecal morphine injection provided better analgesia in early postoperative period.

Therefore, the investigators will examine the effect of single intrathecal morphine injection for postoperative pain control in patients undergoing open pancreaticoduodenectomy to improve postoperative pain management and to explore its potential as one of the effective analgesic methods in ERAS protocol. To this end, the investigators will test non-inferiority between intrathecal morphine injection and continuous wound infiltration.

Вмешательства

• Препарат Intrathecal morphine injection
  A single dose of intrathecal morphine is administered prior to induction of general anesthesia. The patient is placed in the lateral decubitus position on the bed and a 25 guage quincke spinal needle is inserted intrathecally at the L4/5 median or paramedian approach to administer 0.2 mg of morphine.
• Устройство Continuous wound infiltration
  Prior to closure of the abdominal wall, a catheter is placed in the preperitoneal space lateral to the surgical incision through the tunneler. The catheter is connected to a prepared infusion pump (275 ml of 0.5% ropivacaine, 4 ml/hr/catheter), and the remaining catheter protruding from the abdomen is secured with a catheterization dressing. The preperitoneal catheter is removed in the afternoon of postoperative day 3.

Первичные конечные точки

• Mean pain intensity on cough assessed by K-DVRPS at 24, 48, and 72 hours from the end of anesthesia [Срок оценки: Postoperative days 1 to 3]

Вторичные конечные точки (5)

• Mean pain intensity at rest assessed by K-DVRPS at 24, 48, and 72 hours from the end of anesthesia [Срок оценки: Postoperative days 1 to 3]
• Pain intensity at rest and on cough assessed at 2, 24, 48, and 72 hours from end of anesthesia [Срок оценки: Postoperative days 0 to 3]
• Cumulative dose of opioid use at 6, 12, 24, 48, and 72 hours after end of anesthesia [Срок оценки: Postoperative days 0 to 3]
• Quality of recovery at 24, 48, and 72 hours from the end of anesthesia [Срок оценки: Postoperative days 1 to 3]
• Postoperative complications [Срок оценки: Within 1 week after surgery]

Критерии участия

Критерии включения

• Adults 19 years of age or older
• Scheduled for elective open pancreaticoduodenectomy or pylorus preseriving pancreaticoduodenectomy
• Disease of periampullary lesions
• Perfromance status assessed with ECOG score is 0 or 1 at the time of enrollment
• Able to provide written informed consent to participate in the study, understand the procedures of this study, and complete patient-reported questionnaires
• American Society of Anesthesiologists physical status I to III

Критерии исключения

• Hypersensitivity to medications used for pain control (fentanyl, ropivacaine, morphine, acetaminophen, NSAIDs)
• Cognitive impairment that affects using patient-controlled analgesia device or answering patient-reported questionnaires
• Infection or anatomical abnormalities of the abdominal wall and skin that preclude catheterization for continuous wound infiltration
• Contraindicated for intrathecal injection due to any coagulation disorder or continued use of anticoagulants
• Have a major medical or psychiatric illness that would affect response to treatment
• History of chronic pain, or chronic use of analgesics or psychiatric medications
• Have severe liver or kidney disease
• Anyone who are not appropriate for the study in the opinion of the investigators

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

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

South Korea · 1 центр

• Seoul National University Hospital — Seoul

Публикации

• Yoon S, Kim T, Lee HJ, Park N, Jung HS, Cho YJ, Kwon W, Park JS, Jung CW, Jang JY. A randomized, noninferiority clinical trial of Single-Shot Intrathecal Morphine versus Continuous Wound Infiltration for postoperative pain control after open pancreatoduodenectomy. Br J Surg. 2026 Jul 6:znag088. doi: 10.1093/bjs/znag088. Online ahead of print. PMID 42403225

Идентификаторы

NCT: NCT06761989 · H-2411-020-1585

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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