Inflammatory Response, Pain, Pneumoperitoneum
Conditions
Keywords
Clinical trial, low pressure insufflation, pneumoperitoneum, laparoscopic cholecystectomy, pain, inflammatory marker
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURElow-pressure pneumoperitoneum
insufflation of the abdomen for creation of pneumoperitoneum, pressure set points between 8 to 10 mm Hg
PROCEDUREstandard-pressure pneumoperitoneum
insufflation of the abdomen for creation of pneumoperitoneum, pressure set points between 12 to 14 mm Hg
Sponsors
University of Jordan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
participants were divided into two masked groups, labelled red and green; those operated at low-pressure pneumoperitoneum (green-label) and those operated at standard-pressure pneumoperitoneum (red-label).
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Elective admission for laparoscopic cholecystectomy
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| assessment of pain with SPS-11 at 6hr post-op | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| assessment of difficulty of surgery | start to end of the study, 1 year | 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 |
| assessment of difference in operation time | start to end of the study, 1 year | 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 |
Countries
Jordan
Outcome results
None listed