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
TREATMENT
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
assessment of pain with SPS-11 at 6hr 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
Time frame: pre-op to 6 hours post op
change in IL-6
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
Time frame: pre op to 24 hours post -op
assessment of difficulty of surgery
to measure difference in surgery difficulty between the two groups using a scale of 1; easy, 2; moderate, 3; difficult. analysis done using Chi-square cross table on SPSS V 1.0.0.1406
Time frame: start to end of the study, 1 year
assessment of difference in operation time
to look for difference in operation time between the two groups, calculated in minutes. analysis done using Student's 2-tailed t-test on SPSS V 1.0.0.1406
Time frame: start to end of the study, 1 year
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