Effect of Low-pressure Pneumoperitoneum on Pain and Inflammation Post Laparoscopic Cholecystectomy: A Randomized, Double-blinded, Controlled, 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
- change from baseline in ESR value at 24hr 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
- Supportive Care
- 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
change from baseline in ESR value at 24hr post op
时间窗: baseline and 24 hours post-op
calculate the rise in erythrocyte sedimentation rate value as inflammatory marker post-op in millimeters per hour. change = (post-op ESR) - (baseline ESR)
change from baseline in TNF level at 24hr post op
时间窗: baseline and 24 hours post-op
calculate the rise in tumor necrosis factor alpha level as inflammatory marker post-op in pg/mL change = (post-op TNF) - (baseline TNF)
change from baseline in WBC count at 24hr post op
时间窗: baseline and 24 hours post-op
calculate the rise in white blood cycles count as inflammatory marker post-op in 1000 cells per cubic millimeter of blood. change = (post-op WBC count) - (baseline WBC count)
change from baseline in pain on the 11-point short pain scale (SPS-11) at hour 12 post-op
时间窗: baseline and 12 hours post-op
the SPS-11 is a validated, self-reported numeric instrument assessing pain intensity, ranging from 0 to 10; where 0 is no pain, and 10 is the worst pain felt ever. change = (pain score at 12-hr post-op) - (baseline pain score assessed at 6-hr post-op)
change from baseline in pain on the 11-point short pain scale (SPS-11) at hour 24 post-op
时间窗: baseline and 24 hours post-op
the SPS-11 is a validated, self-reported numeric instrument assessing pain intensity, ranging from 0 to 10; where 0 is no pain, and 10 is the worst pain felt ever. change = (pain score at 24-hr post-op) - (baseline pain score assessed at 6-hr post-op)
change from baseline in cortisol level at 4hr post op
时间窗: baseline and 4 hours post-op
calculate the rise in cortisol level as inflammatory marker post-op in nmol/L change = (post-op cortisol ) - (baseline cortisol )
change from baseline in pain on the 11-point short pain scale (SPS-11) at day 7 post-op
时间窗: baseline and 7 days post-op
the SPS-11 is a validated, self-reported numeric instrument assessing pain intensity, ranging from 0 to 10; where 0 is no pain, and 10 is the worst pain felt ever. change = (pain score at post-op day 7) - (baseline pain score assessed at 6-hr post-op)
change from baseline in Plt count at 24hr post op
时间窗: baseline and 24 hours post-op
calculate the rise in platelets count as inflammatory marker post-op in × 10\^9/L of blood change = (post-op Plt count) - (baseline Plt count)
change from baseline in CRP level at 24hr post op
时间窗: baseline and 24 hours post-op
calculate the rise in C reactive protein level as inflammatory marker post-op in mg/L change = (post-op CRP) - (baseline CRP)
change from baseline in IL-6 level at 24hr post op
时间窗: baseline and 24 hours post-op
calculate the rise in interleukin 6 level as inflammatory marker post-op in pg/mL change = (post-op IL-6) - (baseline IL-6)
change from baseline in IL-1 level at 24hr post op
时间窗: baseline and 24 hours post-op
calculate the rise in interleukin 1 level as inflammatory marker post-op in pg/mL change = (post-op IL-1) - (baseline IL-1)
change from baseline in Alb level at 24hr post op
时间窗: baseline and 24 hours post-op
calculate the drop in albumin level as inflammatory marker post-op in g/dL change = (baseline Alb) - (post-op baseline Alb)
change from baseline in IL-17 level at 24hr post op
时间窗: baseline and 24 hours post-op
calculate the rise in interleukin 17 level as inflammatory marker post-op in pg/mL change = (post-op IL-17) - (baseline IL-17)
次要结局
- Difference in surgery time among two groups(through study completion, an average of 1 year)
- Difference in surgery difficulty level among two groups(through study completion, an average of 1 year)
研究者
Hanan Ibrahim Mansour
Dr. Hanan Mansour, post-graduate, general surgery resident
University of Jordan