Evidence map›Paper›PMID 42853845›Full record

Trial reportPloS one2026

Low pressure (8 mmHg) pneumoperitoneum does not significantly reduce postoperative visual analog scale score after laparoscopic cholecystectomy: Randomized trial.

Amine Ben Safta, Salsabil Nasri, Imen Samaali, Wajih Dougaz, Raja Bousassi, Hajer Taher, Mehdi Khalfallah, Chadli Dziri, Ramzi Nouira

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2026. 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
–field-weighted citation impact
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

9 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.
Wajih DougazDepartment of Digestive Surgery B, Charles Nicolle University Hospital, Tunis, Tunisia.
Raja BousassiFaculty of Medicine of Tunis, University of Tunis El Manar, Tunis, Tunisia.ORCID https://orcid.org/0009-0007-7677-1468
Hajer TaherDepartment of Digestive Surgery B, Charles Nicolle University Hospital, Tunis, Tunisia.
Mehdi KhalfallahDepartment of Digestive Surgery B, Charles Nicolle University Hospital, Tunis, Tunisia.
Chadli DziriDepartment of Digestive Surgery B, Charles Nicolle University Hospital, Tunis, Tunisia.ORCID https://orcid.org/0000-0003-2779-0930
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

backgroundLow-pressure pneumoperitoneum (LPP) has been proposed to improve postoperative pain in laparoscopic surgery. This randomized controlled trial (RCT) aimed to evaluate the impact of LPP versus standard-pressure pneumoperitoneum (SPP) on postoperative pain and surgical outcomes during laparoscopic cholecystectomy.

methodsA randomized, controlled, double-blind trial was performed between November 12, 2024 and December 31, 2025. Patients scheduled for elective laparoscopic cholecystectomy (LC) were randomized into two groups: LPP group (8 mmHg) versus SPP group (14 mmHg). The primary outcome was postoperative pain assessed by the Visual Analogue Scale (VAS) at 6 hours. Secondary outcomes included operative time, analgesic consumption, postoperative nausea and vomiting (PONV), and surgical complications. Data were analyzed using an intention-to-treat approach. This trial has been registered at ClinicalTrials.gov (NCT06685250) on November 11, 2024.

resultsOne hundred sixty consecutive patients were enrolled. There was no statistically significant difference in median VAS pain scores at 6 hours (3 vs. 4; p = 0.221), 12 hours (2 vs. 3; p = 0.074), or 24 hours (1 vs. 2; p = 0.128) postoperatively. However, the mean consumption of paracetamol during the first 24 hours was significantly lower in the LPP group compared to the SPP group (1.04 ± 0.906 vs. 1.35 ± 0.873; p = 0.014). Operative times were similar (59.9 ± 27.5 vs. 58.2 ± 22.4 minutes; p = 0.880). No conversion to laparotomy or major morbidities were recorded.

conclusionLPP (8 mmHg) was feasible without increasing operative duration. It did not show a statistically significant reduction in VAS pain scores at 6 hours. Larger studies are required to confirm safety equivalence regarding rare surgical complications.

Indexed as

Cholecystectomy, LaparoscopicPneumoperitoneum, ArtificialPostoperative PainAdultDouble-Blind MethodFemaleHumansMaleMiddle AgedOperative TimePain MeasurementPostoperative Nausea and VomitingPressureVisual Analog Scale

Identifiers

PMID42853845
PMCPMC13652247

What Socratic holds

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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 Socratic graph.