A Randomized Controlled Trial to Compare the Efficacy and Safety of NALDEBAIN With Intravenous Patient-Controlled Analgesia With Fentanyl for the Treatment of Post-Laparotomy Surgery
试验速览
- 阶段
- 4 期
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- pain assessment (post-OP 48 hours)
研究概览
简要总结
The primary objective of this study is to determine the safety and efficacy of single doses of intramuscular NALDEBAIN on patients scheduled to undergo elective laparotomy. This will be performed by administering NALDEBAIN pre-operatively to subjects scheduled to undergo elective laparotomy, and assessing the safety and efficacy of the drug compared to PCA with fentanyl. The study will demonstrate whether single use of NALDEBAIN is noninferior to PCA with fentanyl or not.
详细描述
Screening (Days -30 to -1) (All Study Subjects)
The nature of the study, as well as the potential risks and benefits associated with study participation, will be fully explained to all potential subjects. The following will then be obtained:
- Informed consent.
- Demographic information, including sex, age, BMI and type of surgery.
- Vital signs, including temperature, respiratory rate, blood pressure and heart rate.
- Medical history, including medication use and history of allergy.
- Physical examination.
- Laboratory testing, including hematological and biochemical tests, and urinalysis.
- ECG and X-ray.
Study Day -1 (All Eligible Subjects)
- Eligible subjects will be required to check into the clinical site before surgery (Day -1). The following procedures will be performed upon check-in:
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female who is among 20 to 80 years of age at screening.
- •Scheduled to electively undergo open-laparotomy.
- •American Society of Anesthesiology Physical Class 1-
- •Ability and willingness to provide informed consent
排除标准
- •Body mass index less than 18 kg/m2 or greater than 30 kg/m
- •History of previous open-laparotomy.
- •Surgery with major complication, or need blood transfusion.
- •History of hypersensitivity or adverse reaction to local anesthetics, opioid, or any ingredient of the medications administered in this study.
- •Severe comorbidity.
- •Chronic preoperative opioid consumption.
- •Pregnant or breastfeeding.
- •Inability to use the PCA device.
研究组 & 干预措施
Nalbuphine Sebacate
receive single dose of NALDEBAIN (150 mg Nalbuphine Sebacate, 75 mg/ml, 2 ml/vial) intramuscularly 24±12 hours before surgery.
干预措施: Nalbuphine Sebacate (Drug)
Fentanyl Citrate
receive intravenous patient-controlled analgesia with fentanyl through 48 hours after surgery.
干预措施: Fentanyl Citrate (Drug)
结局指标
主要结局
pain assessment (post-OP 48 hours)
时间窗: During post-OP 48 hours
Pain assessment (time-specific pain intensity) calculated as the area under the curve of VAS pain intensity scores through 48 hours after surgery.
次要结局
- Patient satisfaction(On discharge Day, between post-OP Day 7 and Day 14)
- Length of postoperative hospital stay(From post-OP to Discharge Day, about 1 to 2 weeks)
- Brief Pain Inventory(pre-OP Day -1, post-OP Day 2 and Day 6)
- Pain assessment (post-OP to Day 6)(From post-OP to Day 6)
- supplemental analgesics(From post-OP to Day 6)
研究者
Jaw-Yuan Wang, MD, PhD
Professor
Kaohsiung Medical University Chung-Ho Memorial Hospital