Clinical trial NCT05530564: Effect of Low-pressure Pneumoperitoneum on Pain and Inflammation in Laparoscopic Cholecystectomy
Official title: Effect of Low-pressure Pneumoperitoneum on Pain and Inflammation in Laparoscopic Cholecystectomy: A Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumoperitoneum
Pain
Inflammatory Response
Keywords: Clinical trial
low pressure insufflation
pneumoperitoneum
laparoscopic cholecystectomy
pain
inflammatory marker
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: assessment of pain with SPS-11 at 6hr post-op
timeFrame: pre-op to 6 hours post op
measure: change in IL-6
timeFrame: pre op to 24 hours post -op
Secondary outcomes:
measure: assessment of difficulty of surgery
timeFrame: start to end of the study, 1 year
measure: assessment of difference in operation time
timeFrame: start to end of the study, 1 year
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Jordan University Hospital
state: Jubaiha
Study officials:
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