NCT06479122招募中4 期
Efficacy of Intravenous Acetaminophen Alone Versus Combination of Acetaminophen/Ibuprofen (Maxigesic®IV) in Multimodal Analgesia After Cesarean Section: a Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Obstetric QoR-11K score 24 hours after end of surgery
研究概览
简要总结
The investigators aim to compare the analgesic efficacy of intravenous acetaminophen alone versus combination of acetaminophen/ibuprofen (Maxigesic®IV) in multimodal analgesia after cesarean section.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients scheduled for elective cesarean section
- •Gestational age > 37+0 weeks
排除标准
- •Emergency cesarean section
- •Multiple pregnancy (e.g. twins, triplets)
- •Body weight < 50 kg
- •Preeclampsia
- •History of hypersensitivity to acetaminophen or ibuprofen
- •History of upper gastrointestinal tract bleeding or gastric ulcer
- •Underlying liver disease
- •Underlying kidney disease or GFR < 90 mL/min/1.73m2
- •Heart failure or severe hypertension
- •History of asthma
- •Chronic use of barbital or tricyclic antidepressants
研究组 & 干预措施
Acetaminophen
Active Comparator
干预措施: Acetaminophen (Drug)
Acetaminophen/Ibuprofen
Experimental
干预措施: Acetaminophen/Ibuprofen (Drug)
结局指标
主要结局
Obstetric QoR-11K score 24 hours after end of surgery
时间窗: 24 hours after end of surgery
Minimum 0, poor recovery; maximum 110, good recovery
次要结局
- Numeric rating scale pain score (0-10) 8 hours after end of surgery(8 hours after end of surgery)
- Numeric rating scale pain score (0-10) 4 hours after end of surgery(4 hours after end of surgery)
- Numeric rating scale pain score (0-10) 48 hours after end of surgery(48 hours after end of surgery)
- Use of patient-controlled analgesia (FTN, micrograms) during the first 48 hours after end of surgery(48 h after end of surgery)
- Use of rescue analgesia during the first 48 hours after end of surgery(48 h after end of surgery)
- Operation time(Duration of operation)
- Injection level of intrathecal drug(After arrival at the operating room)
- Dosage of intrathecal drug (mg, bupivacaine)(After arrival at the operating room)
- Sensory blockade level by time point(0, 5, 10 minutes after intrathecal injection and at the end of operation)
- Numeric rating scale pain score (0-10) 12 hours after end of surgery(12 hours after end of surgery)
- Numeric rating scale pain score (0-10) 24 h after end of surgery(24 h after end of surgery)
- Use of patient-controlled analgesia (FTN, micrograms) during the first 24 hours after end of surgery(24 h after end of surgery)
- Use of rescue analgesia during the first 24 hours after end of surgery(24 h after end of surgery)
- Wound-related complications during hospital stay, up to 5 days(From end of surgery to patient discharge, up to 5 days)
- Anesthesia time(Duration of anesthesia)
研究者
Jeong-Hwa Seo
Professor
Seoul National University Hospital
研究点 (1)
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