Clinical trial NCT04779515: Effect of Low-pressure Pneumoperitoneum on Pain and Inflammation Post Laparoscopic Cholecystectomy
Official title: Effect of Low-pressure Pneumoperitoneum on Pain and Inflammation Post Laparoscopic Cholecystectomy: A Randomized, Double-blinded, Controlled, Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumoperitoneum
Pain
Inflammation
Keywords: low-pressure pneumoperitoneum, lap chole
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2021-03-03
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: SUPPORTIVE_CARE

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: change from baseline in pain on the 11-point short pain scale (SPS-11) at hour 12 post-op
timeFrame: baseline and 12 hours post-op
measure: change from baseline in pain on the 11-point short pain scale (SPS-11) at hour 24 post-op
timeFrame: baseline and 24 hours post-op
measure: change from baseline in pain on the 11-point short pain scale (SPS-11) at day 7 post-op
timeFrame: baseline and 7 days post-op
measure: change from baseline in WBC count at 24hr post op
timeFrame: baseline and 24 hours post-op
measure: change from baseline in Plt count at 24hr post op
timeFrame: baseline and 24 hours post-op
measure: change from baseline in ESR value at 24hr post op
timeFrame: baseline and 24 hours post-op
measure: change from baseline in CRP level at 24hr post op
timeFrame: baseline and 24 hours post-op
measure: change from baseline in Alb level at 24hr post op
timeFrame: baseline and 24 hours post-op
measure: change from baseline in cortisol level at 4hr post op
timeFrame: baseline and 4 hours post-op
measure: change from baseline in IL-6 level at 24hr post op
timeFrame: baseline and 24 hours post-op
measure: change from baseline in IL-17 level at 24hr post op
timeFrame: baseline and 24 hours post-op
measure: change from baseline in IL-1 level at 24hr post op
timeFrame: baseline and 24 hours post-op
measure: change from baseline in TNF level at 24hr post op
timeFrame: baseline and 24 hours post-op
Secondary outcomes:
measure: Difference in surgery difficulty level among two groups
timeFrame: through study completion, an average of 1 year
measure: Difference in surgery time among two groups
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Jordan University Hospital
state: Jubaiha
Study officials:
affiliation: University of Jordan
name: Salam Daradkeh, Prof.
role: STUDY_CHAIR
affiliation: University of Jordan
name: Mohammad Rashdan, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Jordan
name: Raed Al-Taher, Prof.
role: STUDY_DIRECTOR
References: