NCT02154464Unknown不适用
Morphine-sparing Effect of Intravenous Paracetamol for Post-operative Pain Management Following Laparoscopic Gastric Banding in Morbidly Obese Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- amount of morphine
研究概览
简要总结
The investigators predict that giving patients paracetamol in the operative period will reduce their need for opioid pain reducers in the post operative setting.
详细描述
This study is designed as a population-based prospective, double blind cohort study. A prospective cohort of patients admitted to laparoscopic gastric banding due to morbid obesity
STUDY GOALS
- To evaluate the morphine-sparing effect of paracetamol IV in obese patients undergoing bariatric surgery.
- To identify potential ability of paracetamol IV to attenuate or relief postoperative pain in obesity patient undergoing bariatric surgery
- To determine effectiveness of paracetamol IV to reduce postoperative complication rate.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years
- •Patients admitted for laparoscopic gastric banding
- •Elective surgery
- •BMI > 40
- •ASA (American Society Anesthesiologists perioperative risk stratification) class 1-2
排除标准
- •Patients' refusal to participate in the study
- •Patients unable to give an informed consent
- •Pregnancy
- •Emergent surgery
- •Patient with known allergy to morphine or paracetamol
- •Patient with hepatic failure (based on history or elevated liver enzymes).
- •ASA class >2.
研究组 & 干预措施
Paracetamol
Active Comparator
干预措施: Paracetamol (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
amount of morphine
时间窗: Until discharge (participants will be followed for the duration of hospital stay, an expected average of 3 days)
The primary outcome will be the comparison amount of morphine injected in each group until discharge
次要结局
- Length of hospitalization(Until discharge from hospital (participants will be followed for the duration of hospital stay, an expected average of 3 days))
- Complications during hospitalization.(Until discharge from hospital (participants will be followed for the duration of hospital stay, an expected average of 3 days))
- Complication during treatment of patient in PACU:(Until discarge from PACU (participants will be followed for the duration of PACU stay, an expected average of 2 hours))
- Time discharging from PACU(Until discharge from PACU (participants will be followed for the duration of PACU stay, an expected average of 2 hours))
研究者
Alexander Zlotnik
Professor
Soroka University Medical Center
研究点 (1)
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