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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
100
insufflation of the abdomen for creation of pneumoperitoneum, pressure set points between 8 to 10 mm Hg
insufflation of the abdomen for creation of pneumoperitoneum, pressure set points between 12 to 14 mm Hg
Jordan University Hospital
Amman, Jubaiha, Jordan
change from baseline in pain on the 11-point short pain scale (SPS-11) at hour 12 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)
Time frame: baseline and 12 hours post-op
change from baseline in pain on the 11-point short pain scale (SPS-11) at hour 24 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)
Time frame: baseline and 24 hours post-op
change from baseline in pain on the 11-point short pain scale (SPS-11) at day 7 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)
Time frame: baseline and 7 days post-op
change from baseline in WBC count at 24hr 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)
Time frame: baseline and 24 hours post-op
change from baseline in Plt count at 24hr 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)
Time frame: baseline and 24 hours post-op
change from baseline in ESR value at 24hr 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)
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Time frame: baseline and 24 hours post-op
change from baseline in CRP level at 24hr post op
calculate the rise in C reactive protein level as inflammatory marker post-op in mg/L change = (post-op CRP) - (baseline CRP)
Time frame: baseline and 24 hours post-op
change from baseline in Alb level at 24hr post op
calculate the drop in albumin level as inflammatory marker post-op in g/dL change = (baseline Alb) - (post-op baseline Alb)
Time frame: baseline and 24 hours post-op
change from baseline in cortisol level at 4hr post op
calculate the rise in cortisol level as inflammatory marker post-op in nmol/L change = (post-op cortisol ) - (baseline cortisol )
Time frame: baseline and 4 hours post-op
change from baseline in IL-6 level at 24hr 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)
Time frame: baseline and 24 hours post-op
change from baseline in IL-17 level at 24hr 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)
Time frame: baseline and 24 hours post-op
change from baseline in IL-1 level at 24hr 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)
Time frame: baseline and 24 hours post-op
change from baseline in TNF level at 24hr 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)
Time frame: baseline and 24 hours post-op
Difference in surgery difficulty level among two groups
assessing level of surgery difficulty between low and standard pressure pneumoperitoneum groups. Difficulty was self reported by operating surgeon as easy (score=1), moderate (score=2), or difficult (score=3). Difference assessed by calculating average between groups
Time frame: through study completion, an average of 1 year
Difference in surgery time among two groups
assessing difference in insufflation time calculated in minutes between low and standard pressure pneumoperitoneum groups. insufflation time was calculated from time of creation of pneumoperitoneum to deflation of the abdomen. Difference assessed by calculating average between groups
Time frame: through study completion, an average of 1 year