The Effect of Timing of Intravenous Paracetamol Administration on Post-surgical Pain and Cytokines Levels Following Laparoscopic Sleeve Gastrectomy
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 126
- 主要终点
- measuring of Visual Analogue pain Scale,
研究概览
简要总结
This study is designed as a population-based prospective randomized cohort study. A prospective cohort of patients admitted to laparoscopic sleeve gastrectomy due to morbid obesity
详细描述
All adult consecutive patients admitted to surgical departments for laparoscopic sleeve gastrectomy will be enrolled prospectively.
For the purposes of the current study we want to determine how much paracetamol (acetaminophen) can reduce the cytokines levels in these patients
The study enrollment period is planned to be a year. The follow-up period for each patient will be until discharge from the hospital.
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
- 18 Years 至 100 Years（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 sleeve gastrectomy
- •Elective surgery
- •BMI > 40
- •American Society of Anesthesiology Classification: 1-2
排除标准
- •Patients' refusal to participate in the study
- •Patients unable to give an informed consent
- •Pregnancy
- •Emergency surgery
- •Patient with known allergy to paracetamol
- •Patient with hepatic failure
- •international normalized ratio >1.7
- •Albumin<3.5g/Dl
- •Bilirubin >2mg/dL
- •Patient with fever > 37.5 ° C
- •Patient with hemoglobin < 8
- •Patients chronically treated with steroids or steroid-treated patients over a month in the year preceding surgery.
- •Drug addict
研究组 & 干预措施
IV paracetamol
Patients in the first group will receive in the operating room before surgery 1 gram (100 ml) of intravenous paracetamol ( IV paracetamol) for 15 minutes intraoperative
干预措施: IV paracetamol (Drug)
IV saline (NaCl 0.9 %)
Patients in the second group will receive 100 mL NACL 0.9% (IV NaCl 0.9 %)intraoperative
干预措施: IV saline (NaCl 0.9 %) (Drug)
结局指标
主要结局
measuring of Visual Analogue pain Scale,
时间窗: up to 48 hours after surgery
Visual Analogue pain Scale to determine patient level of pain , for establish the correct timing of paracetamol administration
measuring of Cytokine levels
时间窗: up to 48 hours after surgery
measuring of Cytokine levels in comparison of timing of paracetamol administration , as a predictor for inflammatory mediators released in response to noxious stimuli
次要结局
- septic post-operative complication while recovering in post anesthesia care unit(up to 5 hours after surgery)
- urinary trak post-operative complication while in ward(up to 72 hours after surgery)
- post-operative pruritus while in ward(up to 72 hours after surgery)
- post-operative hospitalization(up to one week after surgery)
- Total consumption of opiates after surgery(up to 72 hours after surgery)
- Gastrointestinal post-operative complication while recovering in post anesthesia care unit(up to 5 hours after surgery)
- Respiratory post-operative complication while in ward(up to 72 hours after surgery)
- septic post-operative complication while in ward(up to 72 hours after surgery)
- Cardiovascular post-operative complication while in ward(up to 72 hours after surgery)
- Gastrointestinal post-operative complication while in ward(up to 72 hours after surgery)
- Respiratory post-operative complication while recovering in post anesthesia care unit(up to 5 hours after surgery)
- Cardiovascular post-operative complication while recovering in post anesthesia care unit(up to 5 hours after surgery)
- post-operative stay in post anesthesia care unit(up to 5 hours after surgery)
- urinary retention post-operative complication while recovering in post anesthesia care unit(up to 5 hours after surgery)
- post-operative pruritus while recovering in post anesthesia care unit(up to 5 hours after surgery)
研究者
Yair Binyamin MD
principal lnvestigator
Soroka University Medical Center