An interventional study of Low pneumoperitoneum and Local anaesthetic instillation to gallbladder bed in Gallstones and Pain, sponsored by Assiut University. Active, not recruiting at 1 site in Egypt. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Assiut University · Not applicable, Interventional, and Other
The investigators collected 200 patients underwent safe uncomplicated laparoscopic cholecystectomy, then different strategies of pain control are used.
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.
199 studies on the registry are indexed under Gallstones; 35 are open to participants now.
This study's planned enrollment of 200 is above the median of 98 across 121 interventional studies indexed under Gallstones.
Browse Gallstones studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neither local anaesthetic nor low pressure pneumoperitoneum is used during laparoscopic cholecystectomy procedure.
Procedure: Normal Saline (Placebo)
Instillation of local anaesthetic (bupivicaine) to the gallbladder bed in patients with laparoscopic cholecystectomy.
Procedure: Local anaesthetic instillation to gallbladder bed
Low pressure pneumoperitoneum is used during laparoscopic cholecystectomy procedure (8 : 10mmHg).
Procedure: Low pneumoperitoneum
Both local anaesthetic instillation and r low pressure pneumoperitoneum is used during laparoscopic cholecystectomy procedure
Procedure: Low pneumoperitoneum · Procedure: Local anaesthetic instillation to gallbladder bed
Low pressure pneumoperitoneum is done at 8 : 10 mmHg.
Instillation of local anaesthetic at gallbladder bed
Also known as: Bupivicaine
Normal saline injection at the gallbladder bed as placebo.
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.
Time frame: 6 hours after surgery
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.
Time frame: 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.
Time frame: 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.
Time frame: At discharge (up to 48 hours postoperatively)
Plan to share: Undecided — It's still undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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