Postoperative PainCPOPNCT06685250
Postoperative Pain After a Laparoscopic Cholecystectomy
A study testing Laparoscopic cholecystectomy in people with Postoperative Pain, run by Hopital Charles Nicolle.
Trial summary
Randomized Controlled Trial to compare the effect of low (8 mmHg) versus Standard (14 mmHg) insufflation pressure of CO2 pneumoperitoneum on postoperative pain in patients undergoing laparoscopic cholecystectomy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Laparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- No sites listed yet
- Study dates
- 12 Nov 2024to 2 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 1 or ASA 2
- uncomplicated symptomatic gallblader lithiasis scheduled for elective surgery
- no choledocholithiasis
- no associated surgical procedures
- no cerebrovasculare accident with neurological sequelae or other neurological disorders that affects sensation of pain
- no ascites
- no carcinomatosis
Who cannot join
- conversion to laparotomy
- need to keep an escat drain
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Randomized Controlled Trial Comparing Low (8 MmHg) Vs. Standard (14 MmHg) CO2 Insufflation Pressure on Postoperative Pain in Patients Undergoing Laparoscopic Cholecystectomy
Randomized Controlled Trial to compare the effect of low (8 mmHg) versus Standard (14 mmHg) insufflation pressure of CO2 pneumoperitoneum on postoperative pain in patients undergoing laparoscopic cholecystectomy
- Conditions
- Postoperative Pain
- Being tested
- Laparoscopic cholecystectomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic cholecystectomyProcedure or surgery
Laparoscopic cholecystectomy
| Study group | Role | What they receive |
|---|---|---|
| Pressure 8 mmHg | Experimental | Not described Receives: Procedure: Laparoscopic cholecystectomy |
| Pressure 14 mmHg | Active comparator | Not described Receives: Procedure: Laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Visual Analog Scale (VAS) .from 0 to 10 0 no pain, 5 moderate pain, 10 worst possible pain
Measured: Hour 6
Secondary outcomes (5)
postoperative pain
Visual Analog Scale (VAS) 0 no pain, 10 worst possible pain
Measured: Hour 12
Postoperative pain
Visual Analog Scale 0 no pain, 10 worst possible pain
Measured: Hour 24
vommiting (PONV score)
Postoperative Nausea and vomiting (PONV) score 0 no PONV , 1 moderate nausea, 2 moderate vomiting, 3 uncontrollable nausea and/or vomiting
Measured: from 0 to 24 hours after surgery
morbidity
Measured: 30 days
postoperative length of stay
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start12 Nov 2024 (estimated)
- Primary completion2 Nov 2025 (estimated)
- Study completion2 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopital Charles Nicolle
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Amine BEN SAFTA, Hopital Charles Nicolle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06685250
- Sponsor's protocol ID
- Chir-BS-2024-01
- Acronym
- CPOP
- Status last verified
- Nov 2024
- First submitted
- 8 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Safta AB, Nasri S, Samaali I, Dougaz W, Bousassi R, Taher H, Khalfallah M, Dziri C, Nouira R. Low pressure (8 mmHg) pneumoperitoneum does not significantly reduce postoperative visual analog scale score after laparoscopic cholecystectomy: Randomized trial. PLoS One. 2026 Oct 9;21(10):e0360476. doi: 10.1371/journal.pone.0360476. eCollection 2026.
PubMed 42853845Ben Safta A, Nasri S, Samaali I, Taher H, Trabelsi MM, Dziri C, Dougaz W, Nouira R. Randomized controlled trial comparing low pressure (8 mmHg) versus high pressure (14 mmHg) CO2 insufflation on postoperative pain in patients undergoing laparoscopic cholecystectomy: Protocol. PLoS One. 2025 Dec 18;20(12):e0339161. doi: 10.1371/journal.pone.0339161. eCollection 2025.
PubMed 41411326
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Low (8 MmHg) Vs. Standard (14 MmHg) CO2 Insufflation Pressure on Postoperative Pain in Patients Undergoing Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT06685250
- Acronym / sponsor ID
- CPOP / Chir-BS-2024-01
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Hopital Charles NicolleUniversity, hospital or other
- Study start
- 12 Nov 2024 (estimated)
- Primary completion
- 2 Nov 2025 (estimated)
- Study completion
- 2 Dec 2025 (estimated)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized Controlled Trial to compare the effect of low (8 mmHg) versus Standard (14 mmHg) insufflation pressure of CO2 pneumoperitoneum on postoperative pain in patients undergoing laparoscopic cholecystectomy
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pressure 8 mmHg | Experimental | Procedure: Laparoscopic cholecystectomy |
| Pressure 14 mmHg | Active comparator | Procedure: Laparoscopic cholecystectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ASA 1 or ASA 2
- uncomplicated symptomatic gallblader lithiasis scheduled for elective surgery
- no choledocholithiasis
- no associated surgical procedures
- no cerebrovasculare accident with neurological sequelae or other neurological disorders that affects sensation of pain
Key exclusion criteria (2 listed)
- conversion to laparotomy
- need to keep an escat drain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic cholecystectomyLaparoscopic cholecystectomy | Procedure or surgery | Pressure 14 mmHg, Pressure 8 mmHg |
Primary outcome
Postoperative pain
Time frame: Hour 6
Visual Analog Scale (VAS) .from 0 to 10 0 no pain, 5 moderate pain, 10 worst possible pain
5 secondary outcomes
postoperative pain
Time frame: Hour 12
Postoperative pain
Time frame: Hour 24
vommiting (PONV score)
Time frame: from 0 to 24 hours after surgery
morbidity
Time frame: 30 days
postoperative length of stay
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Derived from this study: PubMed 42853845Safta AB, Nasri S, Samaali I, Dougaz W, Bousassi R, Taher H, Khalfallah M, Dziri C, Nouira R. Low pressure (8 mmHg) pneumoperitoneum does not significantly reduce postoperative visual analog scale score after laparoscopic cholecystectomy: Randomized trial. PLoS One. 2026 Oct 9;21(10):e0360476. doi: 10.1371/journal.pone.0360476. eCollection 2026.
- Derived from this study: PubMed 41411326Ben Safta A, Nasri S, Samaali I, Taher H, Trabelsi MM, Dziri C, Dougaz W, Nouira R. Randomized controlled trial comparing low pressure (8 mmHg) versus high pressure (14 mmHg) CO2 insufflation on postoperative pain in patients undergoing laparoscopic cholecystectomy: Protocol. PLoS One. 2025 Dec 18;20(12):e0339161. doi: 10.1371/journal.pone.0339161. eCollection 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic cholecystectomy in people with Postoperative Pain, run by Hopital Charles Nicolle.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amine Ben Safta, Assistant hospitalo-universita (+216 29 693 979, amine.bsa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: Hour 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06685250, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.