Low vs. standard volume EXORA block for pain control in laparoscopic gallbladder surgery
Official title: Analgesic Efficacy of Low-Volume Versus Standard-Volume 0.25% Bupivacaine for Ultrasound-Guided External Oblique and Rectus Abdominis Plane Block in Laparoscopic Cholecystectomy, A Randomized Non-Inferiority Trial
Run by Fayoum University Hospital · NCT07507799 · Data updated 2026-11-12
This trial tests whether a smaller amount of local anesthetic given as a bilateral EXORA block provides pain relief after laparoscopic cholecystectomy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 96 (estimated) |
| Sponsor | Fayoum University Hospital Academic / other |
| Locations | 1 site (El Fayoum Qesm, Faiyum Governorate) |
| Status | Recruiting |
| Started | April 12, 2026 |
| Main results expected | January 1, 2027 |
| Study ends | January 2, 2027 |
| Registry record updated | September 2, 2026 |
| Trial ID | NCT07507799 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with ASA I–II undergoing elective laparoscopic cholecystectomy, without contraindications to regional anesthesia or local anesthetics.
✕Probably not a fit
Patients with high body mass index >35 kg/m2, infection at the injection site, coagulopathy, pregnancy, chronic pain or opioid use, or conversion to open surgery may experience less benefit or none.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, randomized, double-blinded study compares two bilateral EXORA block volumes (15 mL vs 25 mL per side) using 0.25% bupivacaine in patients undergoing elective laparoscopic cholecystectomy. Participants are allocated to one of two groups before anesthesia, with blinding maintained for patients, surgical team, anesthesiologists, and data collectors. The primary aim is to evaluate analgesic efficacy while monitoring safety and intraoperative/postoperative management within a standardized anesthesia protocol. Block performance is ultrasound-guided and performed by a designated anesthesiologist not involved in postoperative care. Outcomes will include postoperative analgesia requirements and pain scores within the first 24 hours.
Why it matters
Potential benefit: If successful, using a lower-volume EXORA block could maintain pain control while reducing local anesthetic exposure and potential toxicity.
How similar studies have gone: Prior regional anesthesia approaches with reduced volumes have shown variable analgesic efficacy; this study adds targeted data for EXORA technique in this procedure.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * American Society of Anesthesiologists (ASA) physical status I or II. * Scheduled for elective laparoscopic cholecystectomy under general anesthesia. Exclusion Criteria: * • Patient refusal to participate. * Obese patients with a body mass index of more than 35 kg/m2. * Known cognitive impairment or use of psychiatric drugs * Known allergy to local anesthetics * Infection at the needle insertion site. * Coagulopathy, or bleeding disorders. * Pregnancy * History of chronic pain or chronic opioid use. * Previous major upper abdominal surgery (which alters the fascial planes and anatomy). Criteria for Withdrawal from Study Analysis (Drop-outs): * Conversion to open cholecystectomy during surgery. * Failed EXORA block
Where it's running
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Fayoum University hospital
El Fayoum Qesm, Faiyum Governorate, Egypt Recruiting
Study contacts
- Principal investigator: Mohamed A Hamed,, MD — Faculty of medicine, Fayoum university
- Study coordinator: Mohammed R Gomaa, Bch
- Email: mr147@fayoum.edu.eg
- Phone: 1097830069
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.