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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Mean pain intensity on cough assessed by K-DVRPS at 24, 48, and 72 hours from the end of anesthesia
研究概览
简要总结
This is a prospective randomized open-label noninferiority trial that compares intrathecal morphine injection and continuous wound infiltration after open pancreaticoduodenectomy.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Intrathecal morphine injection
A single dose of intrathecal morphine is administered prior to induction of general anesthesia. Other postoperative pain management follows the institution's protocol including intravenous patient controlled analgesia.
干预措施: Intrathecal morphine injection (Drug)
Continuous wound infiltration
A catheter is inserted at preperitoneal space at the end of surgery and ropivacaine is continuously infused until postoperative day 3. Other postoperative pain management follows the institution's protocol including intravenous patient controlled analgesia.
干预措施: Continuous wound infiltration (Device)
结局指标
主要结局
Mean pain intensity on cough assessed by K-DVRPS at 24, 48, and 72 hours from the end of anesthesia
时间窗: Postoperative days 1 to 3
The K-DVPRS (Korean version of Defense and Veterans Pain Rating Scale), ranging from 0 to 10, is used to assess postoperative pain on cough at 24, 48, and 72 hours after the end of anesthesia. The mean K-DVPRS pain score for 3 time points is compared between two groups.
次要结局
- Mean pain intensity at rest assessed by K-DVRPS at 24, 48, and 72 hours from the end of anesthesia(Postoperative days 1 to 3)
- Pain intensity at rest and on cough assessed at 2, 24, 48, and 72 hours from end of anesthesia(Postoperative days 0 to 3)
- Cumulative dose of opioid use at 6, 12, 24, 48, and 72 hours after end of anesthesia(Postoperative days 0 to 3)
- Quality of recovery at 24, 48, and 72 hours from the end of anesthesia(Postoperative days 1 to 3)
- Postoperative complications(Within 1 week after surgery)
研究者
Hojin Lee, MD, PhD
Associated Professor
Seoul National University Hospital