Prospective Randomized Trial to Evaluate the Efficacy and Safety of Maxigesic Injection for Post-operative Pain Control in Patients Who Have Undergone Laparoscopic or Robotic Gastrectomy
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Sum of Pain Intensity Differences Over 72 Hours (SPID72)
研究概览
简要总结
This prospective, randomized, phase 4 clinical trial aims to evaluate the efficacy and safety of intravenous Maxigesic, a fixed-dose combination of acetaminophen and ibuprofen, for postoperative pain control in patients undergoing laparoscopic or robotic gastrectomy for gastric cancer. A total of 90 participants will be randomly assigned to receive either Maxigesic or intravenous acetaminophen. The primary objective is to compare postoperative pain control between the two groups using the sum of pain intensity differences over 72 hours (SPID72). Secondary outcomes include postoperative pain scores, opioid consumption, rescue analgesic use, antiemetic use, and safety outcomes.
详细描述
Postoperative pain management is an important component of recovery after gastrectomy. Opioids are commonly used for the treatment of acute postoperative pain; however, opioid-related adverse effects and concerns regarding excessive opioid exposure have increased interest in multimodal analgesic strategies that combine non-opioid analgesics.
Maxigesic is an intravenous fixed-dose combination of acetaminophen 1,000 mg and ibuprofen 300 mg. This study is designed to evaluate whether perioperative administration of Maxigesic provides effective postoperative analgesia and reduces the need for opioid and rescue analgesics compared with intravenous acetaminophen alone in patients undergoing minimally invasive gastrectomy for gastric cancer.
A total of 90 adult participants scheduled to undergo laparoscopic or robotic gastrectomy will be randomly assigned in a 1:1 ratio to the Maxigesic group or the acetaminophen control group. Participants assigned to the Maxigesic group will receive intravenous Maxigesic at the initiation of anesthesia and subsequently at 6-hour intervals after surgery through 72 hours after surgery. Participants assigned to the control group will receive intravenous acetaminophen 1,000 mg at 6-hour intervals according to the postoperative analgesic protocol. Postoperative patient-controlled analgesia containing fentanyl will be available, and additional rescue analgesics may be administered as clinically indicated.
Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS) immediately after surgery and at 12, 24, 48, and 72 hours after surgery. The primary efficacy outcome is the sum of pain intensity differences over the first 72 postoperative hours (SPID72). Secondary efficacy outcomes include NRS pain scores at predefined postoperative time points, total opioid consumption during the first 48 hours, the number of rescue analgesic administrations during the first 48 hours, and the use of antiemetic medications during the first 48 hours. Safety will be evaluated through the assessment of adverse events until postoperative day 5 or hospital discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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 aged 19 years or older at the time of written informed consent.
- •Patients scheduled to undergo laparoscopic or robotic gastrectomy for gastric cancer.
- •American Society of Anesthesiologists (ASA) physical status class I to III.
- •Patients who voluntarily decide to participate after receiving a detailed explanation of the study and provide written informed consent.
排除标准
- •Patients who do not undergo laparoscopic or robotic gastrectomy.
- •Patients who require conversion to open surgery.
- •Known hypersensitivity to any component of the study medications.
- •Any contraindication to the use of the study medications according to the prescribing information.
- •Women who are pregnant or breastfeeding, or who plan to become pregnant during the study period.
- •Participants or their partners who do not agree to use a medically acceptable method of contraception during the study period.
研究组 & 干预措施
Acetaminophen Arm
Participants receive intravenous acetaminophen 1,000 mg every 6 hours, four times daily, from postoperative day 0 through postoperative day 2, with a maximum daily dose of 4,000 mg. Postoperative fentanyl-based patient-controlled analgesia (PCA) is also provided.
干预措施: Acetaminophen (Drug)
Maxigesic Arm
Participants receive intravenous Maxigesic (acetaminophen 1,000 mg/ibuprofen 300 mg in 100 mL) beginning at the initiation of anesthesia and subsequently at 6-hour intervals during the postoperative treatment period through 72 hours, according to the study protocol. Postoperative fentanyl-based patient-controlled analgesia (PCA) is also provided.
干预措施: Acetaminophen and Ibuprofen (Drug)
结局指标
主要结局
Sum of Pain Intensity Differences Over 72 Hours (SPID72)
时间窗: From immediately after surgery through 72 hours after surgery
Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS) immediately after surgery and at 12, 24, 48, and 72 hours after surgery. The primary outcome is the sum of pain intensity differences over the first 72 postoperative hours (SPID72).
次要结局
- Postoperative Pain Intensity Assessed by Numeric Rating Scale (NRS)(Immediately after surgery and at 12, 24, and 48 hours after surgery)
- Number of Antiemetic Administrations(From the end of surgery through 48 hours after surgery)
- Total Opioid Consumption(From the end of surgery through 48 hours after surgery)
- Number of Rescue Analgesic Administrations(From the end of surgery through 48 hours after surgery)
研究者
So Hyun Kang
Professor
Seoul National University Bundang Hospital