Effect of Low-pressure Pneumoperitoneum on Pain and Inflammation in Laparoscopic Cholecystectomy: A Prospective Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- assessment of pain with SPS-11 at 6hr post-op
研究概览
简要总结
The purpose of this study is to assess the effect of low-pressure pneumoperitoneum on post operative pain and inflammation in patients undergoing elective laparoscopic cholecystectomy by comparing it to standard practice.
详细描述
After obtaining informed consent from eligible study participants. patients were randomized into one of two masked groups, labelled red and green. The red-label group was operated at standard-pressure pneumoperitoneum, while the green-label group was operated at low-pressure pneumoperitoneum. Baseline blood samples were obtained pre-operatively for ten inflammatory markers, patients' demographics and intra-operative details collected, then post-operative pain and change in inflammatory markers were followed.
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
none of the participants knew at which pressure they will be operated on, nor the physicians who followed participants at floor or those analyzing blood samples, not the assigned physician to collect data, nor the personnel doing the analysis.
only the operating surgeon and circulating nurse were aware of the meaning of the participant assigned label at time of operation. The masking was revealed post completion of analysis.
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective admission for laparoscopic cholecystectomy
排除标准
- •Current or previous diagnosis of acute cholecystitis confirmed by ultrasound
- •previous GI surgeries, except bariatric and anti-reflux surgeries
- •Currently on immunosuppressant agents
- •Pregnancy
- •Breastfeeding
- •Currently diagnosed with drug addiction
- •American Society of Anesthesiologists (ASA) score 3 and more
结局指标
主要结局
assessment of pain with SPS-11 at 6hr post-op
时间窗: pre-op to 6 hours post op
measure difference in pain on the 11-point short pain scale (SPS-11) at 6-hour post-op compared to baseline at pre-op, minimum score of 0 , maximun score of 10 = pain at 6 hour post op - pain at pre-op
change in IL-6
时间窗: pre op to 24 hours post -op
measure differance of inflammatory marker from baseline = baseline value- post op value (calculated in pg/mL) post-op collected at 24 hours from end of surgery
次要结局
- assessment of difficulty of surgery(start to end of the study, 1 year)
- assessment of difference in operation time(start to end of the study, 1 year)
研究者
Hanan Ibrahim Mansour
Dr. Hanan Mansour, M.D.
University of Jordan