Comparison of the Opioid-sparing Effect of Preemptive and Preventive Intravenous Acetaminophen/Ibuprofen Fixed-dose Combination After Robot-assisted Radical Prostatectomy: A Double-blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Total fentanyl consumption during 24 hours
研究概览
简要总结
This prospective, randomized, double-blinded study is designed to compare opioid-sparing effect of preemptive and preventive intravenous acetaminophen/ibuprofen fixed-dose combination in patients undergoing robot-assisted radical prostatectomy (RARP). We hypothesize that preemptive administration of intravenous acetaminophen/ibuprofen fixed-dose combination can significantly reduce postoperative opioid consumption and pain severity than preventive administration in patients undergoing RARP.
详细描述
Adult patients undergoing elective robot-assisted radical prostatectomy are randomly allocated to receive preemptive administration of acetaminophen (1000 mg)/ibuprofen (300 mg) fixed-dose combination (n=77) or preventive administration (n=77). The preemptive administration group will receive intravenous acetaminophen (1000 mg)/ibuprofen (300 mg) for 15 minutes at the end of induction of anesthesia. The preventive administration group will receive same dosage of drug for same duration when surgical site closure starts.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
An investigator who is not involved in this study randomly allocates the group and another investigator who dose not evaluate clinical endpoints keeps the result of allocation in a sealed envelope.
On the day of study, the second investigator opens the envelope to check allocation and sends a drug and normal saline in identical looking bottles with label only indicating the order of administration.
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled to undergo elective robot-assisted radical prostatectomy under general anesthesia
- •American Society of Anesthesiologists (ASA) physical classification I-II
- •Consent to IV-patient controlled analgesia use
- •Willingness and ability to sign an informed consent document
排除标准
- •Who do not understand or agree with our study
- •American Society of Anesthesiologists (ASA) physical classification III-IV
- •Chronic usage of opioid analgesics
- •Moderate to severe pain with other cause before surgery
- •Allergies to anesthetic or analgesic medications used in this study
- •Anticipated blood loss larger than 2 liters
- •Need for intensive care after surgery
- •History of gastric ulcer or gastrointestinal bleeding
- •History of liver failure, renal failure or heart failure
- •Current alcoholism
- •Taking anti-coagulation drugs or history of coagulation disease
- •History of bronchial asthma
- •Medical or psychological disease that can affect the treatment response
- •Taking barbitutate or tricyclic antidepressant
研究组 & 干预措施
Preemptive administration group
Preemptive administration group will receive intravenous acetaminophen (1000 mg)/ibuprofen (300 mg) for 15 minutes at the end of induction of anesthesia.
干预措施: Acetaminophen/Ibuprofen fixed-dose combination (Drug)
Preventive administration group
The preventive administration group will receive intravenous acetaminophen (1000 mg)/ibuprofen (300 mg) for 15 minutes when surgical site closure starts.
干预措施: Acetaminophen/Ibuprofen fixed-dose combination (Drug)
结局指标
主要结局
Total fentanyl consumption during 24 hours
时间窗: Postoperative 24 hours
Postoperative fentanyl consumption (mcg) via IV patient controlled analgesia
次要结局
- Total fentanyl consumption(Postoperative 2, 6, 48 hours)
- Count of rescue analgesics administration(Postoperative 0-2, 2-6, 6-24, 24-48 hours)
- Postoperative pain score(Postoperative 2 (resting only), 6, 24, 48 hours)
- Opioid side effects(Postoperative 0-2, 2-6, 6-24, 24-48 hours)
- Quality of recovery-15(Postoperative 24 hours)
研究者
Hojin Lee, MD, PhD
Professor
Seoul National University Hospital