Evidence map›Paper›PMID 41411326›Full record

ArticlePloS one2025

Randomized controlled trial comparing low pressure (8 mmHg) versus high pressure (14 mmHg) CO2 insufflation on postoperative pain in patients undergoing laparoscopic cholecystectomy: Protocol.

Amine Ben Safta, Salsabil Nasri, Imen Samaali, Hajer Taher, Mohamed Mehdi Trabelsi, Chadli Dziri, Wajih Dougaz, Ramzi Nouira

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06685250 (Randomized Controlled Trial Comparing Low), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06685250 nanot yet recruitingnot on this map

Randomized Controlled Trial Comparing Low (8 MmHg) Vs. Standard (14 MmHg) CO2 Insufflation Pressure on Postoperative Pain in Patients Undergoing Laparoscopic Cholecystectomy

TypeinterventionalSponsorHopital Charles NicolleRan2024 to 2025Enrolled190ConditionsPostoperative PainArmsLaparoscopic cholecystectomy
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Amine Ben SaftaDepartment of Digestive Surgery B, Charles Nicolle University Hospital, Tunis, Tunisia.
Salsabil NasriDepartment of Digestive Surgery B, Charles Nicolle University Hospital, Tunis, Tunisia.ORCID https://orcid.org/0000-0001-9565-3562
Imen SamaaliDepartment of Digestive Surgery B, Charles Nicolle University Hospital, Tunis, Tunisia.
Hajer TaherDepartment of Digestive Surgery B, Charles Nicolle University Hospital, Tunis, Tunisia.
Mohamed Mehdi TrabelsiDepartment of Digestive Surgery B, Charles Nicolle University Hospital, Tunis, Tunisia.
Chadli DziriDepartment of Digestive Surgery B, Charles Nicolle University Hospital, Tunis, Tunisia.
Wajih DougazDepartment of Digestive Surgery B, Charles Nicolle University Hospital, Tunis, Tunisia.
Ramzi NouiraDepartment of Digestive Surgery B, Charles Nicolle University Hospital, Tunis, Tunisia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLaparoscopic cholecystectomy is the gold standard for treating symptomatic gallstone disease. Pneumoperitoneum is essential for adequate visualization during the procedure and is typically maintained at a standard pressure of 12-14 mmHg. However, high insufflation pressure may contribute to increased postoperative pain. This study aims to assess whether low-pressure pneumoperitoneum (8 mmHg) reduces postoperative pain compared to standard pressure (14 mmHg), without compromising operative safety or efficacy. We hypothesize that low pressure pneumoperitoneum at 8 mmHg reduces postoperative pain, without increasing operation time or postoperative morbidity.

methodsThis is a single-center, randomized, controlled, double-blind trial. Consecutive Adult patients scheduled for elective laparoscopic cholecystectomy will be randomized in a 1:1 ratio to receive either low-pressure (8 mmHg) or standard-pressure (14 mmHg) pneumoperitoneum. The primary outcome is postoperative abdominal pain assessed using the Visual Analog Scale (VAS) at 6 hours after surgery. Secondary outcomes include VAS pain scores at 12 and 24 hours, postoperative nausea and/or vomiting, postoperative hospital stay and postoperative 30-day morbidity. The enrollment of patients will be done between November 12, 2024 to December 31, 2025.

trial registrationClinicalTrials.gov NCT06685250.

conclusionIf proven effective, low-pressure pneumoperitoneum may represent a simple strategy to improve postoperative comfort in laparoscopic cholecystectomy without compromising surgical outcomes.

Indexed as

Carbon DioxideCholecystectomy, LaparoscopicInsufflationPneumoperitoneum, ArtificialPostoperative PainAdultDouble-Blind MethodFemaleHumansMaleMiddle AgedPain MeasurementPressureRandomized Controlled Trials as TopicCarbon Dioxide

Identifiers

PMID41411326
PMCPMC12714267

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.