GallstonesRandomizedNCT07897435
Comparison of the Efficacy of Different Analgesic Strategies for Pain Control After Laparoscopic Cholecystectomy (LC)
A study testing Low pneumoperitoneum and Local anaesthetic instillation to gallbladder bed in people with Gallstones and Pain, run by Assiut University at 1 site in Egypt.
Trial summary
The investigators collected 200 patients underwent safe uncomplicated laparoscopic cholecystectomy, then different strategies of pain control are used. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Gallstones, Pain
- What is being tested?
- Low pneumoperitoneum and Local anaesthetic instillation to gallbladder bed
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2026to 1 Oct 2028
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients aged between 18 years and 75 years.
- Patients scheduled for elective laparoscopic cholecystectomy.
- ASA physical status class I or II. . Patients willing and able to provide informed consent and cooperate with postoperative pain assessment.
Who cannot join
- - Emergency or acute presentation of LC as (gallbladder empyema, ganrenous GB, perforation, gallstone pancreatitis)
- patients with known or suspected gallbladder carcinoma.
- Patients undergoing cholecystectomy as part of another major abdominal procedure.
- - patients allergic to local anaesthetics.
- Addict patients to opioids / psychic patients or patients with any disease affecting pain reporting.
- The cases of Laparoscopic Cholecystectomy conversion to Open Cholecystectomy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Combined Low-pressure Pneumoperitoneum and Gallbladder Bed Local Anesthetic Instillation on Post-operative Pain After Laparoscopic Cholecystectomy; A Prospective Randomized Comparative Study
The investigators collected 200 patients underwent safe uncomplicated laparoscopic cholecystectomy, then different strategies of pain control are used.
Read the detailed description
Laparoscopic cholecystectomy (LC) is the gold-standard treatment for symptomatic cholelithiasis.
However, postoperative pain-either incisional, visceral, or referred to the back/shoulder tip-remains a major concern regarding morbidity and the duration hospital stay.
There are two independent strategies prescribed to overcome post LC pain, the 1st one is to reduce the pressure of pneumoperitoneum from the conventional 11 - 14 mmHg to 8 - 10 mmHg and the 2nd strategy is the instillation of a local anaesthetic agent (i.e, bupivicaine).
The low pneumoperitoneum proved to lessen the peritoneal stretch and diaphragmatic irritation, while the local anaesthetic targets nociception at its source.
The evidence of both interventions are studied separately. Hence, in our study we aim in our RCT to study the each single strategy separately and the combined effect of both of them.
- Conditions
- Gallstones, Pain
- Being tested
- Low pneumoperitoneum, Local anaesthetic instillation to gallbladder bed, Normal Saline (Placebo)
- Keywords
- Laparoscopic cholecystectomy, Analgesia
- Medical subject headings
- Gallstones, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low pneumoperitoneumProcedure or surgery
Low pressure pneumoperitoneum is done at 8 : 10 mmHg.
Local anaesthetic instillation to gallbladder bedProcedure or surgery
Also called Bupivicaine
Instillation of local anaesthetic at gallbladder bed
Normal Saline (Placebo)Procedure or surgery
Normal saline injection at the gallbladder bed as placebo.
| Study group | Role | What they receive |
|---|---|---|
| Control (standard pressure + saline) | Placebo comparator | Neither local anaesthetic nor low pressure pneumoperitoneum is used during laparoscopic cholecystectomy procedure. Receives: Procedure: Normal Saline (Placebo) |
| GB-bed LA | Active comparator | Instillation of local anaesthetic (bupivicaine) to the gallbladder bed in patients with laparoscopic cholecystectomy. Receives: Procedure: Local anaesthetic instillation to gallbladder bed |
| low pressure pneumoperitoneum | Experimental | Low pressure pneumoperitoneum is used during laparoscopic cholecystectomy procedure (8 : 10mmHg). Receives: Procedure: Low pneumoperitoneum |
| Group with combined strategies | Experimental | Both local anaesthetic instillation and r low pressure pneumoperitoneum is used during laparoscopic cholecystectomy procedure Receives: Procedure: Low pneumoperitoneum; Procedure: Local anaesthetic instillation to gallbladder bed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative abdominal pain intensity by Visual Analogue Scale (VAS) (VAS) at 6 hours after laparoscopic cholecystectomy
Pain intensity on the Visual Analogue Scale (VAS), 0 to 10 cm. 0 = no pain, 10 = worst imaginable pain. Higher score = worse outcome. Compared across the 4 groups (standard pressure + saline, standard pressure + GB-bed bupivacaine, low pressure + saline, low pressure + bupivacaine) by factorial analysis: pressure effect, instillation effect, and pressure × instillation interaction.
Measured: 6 hours after surgery
Secondary outcomes (3)
Abdominal pain VAS at 2, 12 and 24 hours after LC
VAS 0 to 10 cm, at rest and with movement/coughing. 0 = no pain, 10 = worst imaginable pain. Higher = worse.
Measured: 2, 12 and 24 hours after surgery
Shoulder-tip pain VAS after LC
VAS 0 to 10 cm. 0 = no pain, 10 = worst imaginable pain. Higher = worse.
Measured: 2, 6, 12 and 24 hours after surgery
Patient satisfaction with postoperative pain control at discharge
Patient satisfaction with postoperative pain control measured by a 5-point Likert scale. Minimum 1 (very dissatisfied), maximum 5 (very satisfied). Higher score = better outcome.
Measured: At discharge (up to 48 hours postoperatively)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start1 Aug 2026
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GallstonesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hassan Mohammed Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07897435
- Sponsor's protocol ID
- Post cholecystectomy pain
- Acronym
- Randomized
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It's still undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Combined Low-pressure Pneumoperitoneum and Gallbladder Bed Local Anesthetic Instillation on Post-operative Pain After Laparoscopic Cholecystectomy; A Prospective Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT07897435
- Acronym / sponsor ID
- Randomized / Post cholecystectomy pain
- Conditions
- Gallstones, Pain
- Keywords
- Laparoscopic cholecystectomy, Analgesia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 27 Oct 2026 (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.
The investigators collected 200 patients underwent safe uncomplicated laparoscopic cholecystectomy, then different strategies of pain control are used.
Detailed description
Laparoscopic cholecystectomy (LC) is the gold-standard treatment for symptomatic cholelithiasis.
However, postoperative pain-either incisional, visceral, or referred to the back/shoulder tip-remains a major concern regarding morbidity and the duration hospital stay.
There are two independent strategies prescribed to overcome post LC pain, the 1st one is to reduce the pressure of pneumoperitoneum from the conventional 11 - 14 mmHg to 8 - 10 mmHg and the 2nd strategy is the instillation of a local anaesthetic agent (i.e, bupivicaine).
The low pneumoperitoneum proved to lessen the peritoneal stretch and diaphragmatic irritation, while the local anaesthetic targets nociception at its source.
The evidence of both interventions are studied separately. Hence, in our study we aim in our RCT to study the each single strategy separately and the combined effect of both of them.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control (standard pressure + saline) | Placebo comparator | Procedure: Normal Saline (Placebo)Neither local anaesthetic nor low pressure pneumoperitoneum is used during laparoscopic cholecystectomy procedure. |
| GB-bed LA | Active comparator | Procedure: Local anaesthetic instillation to gallbladder bedInstillation of local anaesthetic (bupivicaine) to the gallbladder bed in patients with laparoscopic cholecystectomy. |
| low pressure pneumoperitoneum | Experimental | Procedure: Low pneumoperitoneumLow pressure pneumoperitoneum is used during laparoscopic cholecystectomy procedure (8 : 10mmHg). |
| Group with combined strategies | Experimental | Procedure: Low pneumoperitoneum, Procedure: Local anaesthetic instillation to gallbladder bedBoth local anaesthetic instillation and r low pressure pneumoperitoneum is used during laparoscopic cholecystectomy procedure |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients aged between 18 years and 75 years.
- Patients scheduled for elective laparoscopic cholecystectomy.
- ASA physical status class I or II. . Patients willing and able to provide informed consent and cooperate with postoperative pain assessment.
Key exclusion criteria (6 listed)
- - Emergency or acute presentation of LC as (gallbladder empyema, ganrenous GB, perforation, gallstone pancreatitis)
- patients with known or suspected gallbladder carcinoma.
- Patients undergoing cholecystectomy as part of another major abdominal procedure.
- - patients allergic to local anaesthetics.
- Addict patients to opioids / psychic patients or patients with any disease affecting pain reporting.
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 |
|---|---|---|
| Low pneumoperitoneumLow pressure pneumoperitoneum is done at 8 : 10 mmHg. | Procedure or surgery | Group with combined strategies, low pressure pneumoperitoneum |
| Local anaesthetic instillation to gallbladder bedAlso: BupivicaineInstillation of local anaesthetic at gallbladder bed | Procedure or surgery | GB-bed LA, Group with combined strategies |
| Normal Saline (Placebo)Normal saline injection at the gallbladder bed as placebo. | Procedure or surgery | Control (standard pressure + saline) |
Primary outcome
Postoperative abdominal pain intensity by Visual Analogue Scale (VAS) (VAS) at 6 hours after laparoscopic cholecystectomy
Time frame: 6 hours after surgery
Pain intensity on the Visual Analogue Scale (VAS), 0 to 10 cm. 0 = no pain, 10 = worst imaginable pain. Higher score = worse outcome. Compared across the 4 groups (standard pressure + saline, standard pressure + GB-bed bupivacaine, low pressure + saline, low pressure + bupivacaine) by factorial analysis: pressure effect, instillation effect, and pressure × instillation interaction.
3 secondary outcomes
Abdominal pain VAS at 2, 12 and 24 hours after LC
Time frame: 2, 12 and 24 hours after surgery
Shoulder-tip pain VAS after LC
Time frame: 2, 6, 12 and 24 hours after surgery
Patient satisfaction with postoperative pain control at discharge
Time frame: At discharge (up to 48 hours postoperatively)
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 27 Oct 2026.
- Individual participant dataSharing planned: Undecided. It's still undecided
Related trials for Gallstones
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Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
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Not yet recruiting
Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
RecruitingObservational study
Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
Cholelithiasis
Recruiting
Timing of CHolecystectomy In Severe PAncreatitis
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RecruitingPhase 4
Time to Loss of Consciousness With Remimazolam Versus Propofol for Anesthetic Induction in Laparoscopic Cholecystectomy
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low pneumoperitoneum and Local anaesthetic instillation to gallbladder bed in people with Gallstones and Pain, run by Assiut University at 1 site in Egypt.
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 3 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative abdominal pain intensity by Visual Analogue Scale (VAS) (VAS) at 6 hours after laparoscopic cholecystectomy (time frame: 6 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2026.