Comparing EXORA and erector spinae plane (ESP) nerve blocks for pain after laparoscopic gallbladder removal
The Analgesic Efficacy of EXORA Block Versus Erector Spinae Plane Block in Patients Undergoing Laparoscopic Cholecystectomy Under General Anesthesia
This trial will try two ultrasound-guided nerve blocks (EXORA and ESP) to lower early postoperative pain and opioid use in adults having elective laparoscopic gallbladder surgery, compared with standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 114 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Fayoum University Hospital Academic / other |
| Locations | 1 site (El Fayoum Qesm, Faiyum Governorate) |
| Trial ID | NCT07187310 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized, double-blinded, controlled trial conducted at Fayoum University Hospital that will enroll adults scheduled for elective laparoscopic cholecystectomy and randomize them 1:1:1 to bilateral EXORA block, bilateral erector spinae plane (ESP) block, or no block with standard care. Blocks will be performed preoperatively by experienced anesthesiologists under ultrasound guidance, and patients and outcome assessors will be blinded to group assignment. The protocol includes standardized perioperative monitoring, routine laboratory screening, and postoperative measurement of pain scores and opioid consumption with follow-up until the predefined endpoints. Each arm is planned to include 35 patients (total n≈105) with enrollment starting October 2025 at the single study site.
Who should consider this trial
Good fit: Adults with ASA physical status I–III who are scheduled for elective laparoscopic cholecystectomy and meet the study safety criteria are ideal candidates.
Not a fit: Patients with chronic pain or regular opioid use, coagulopathy or anticoagulant therapy, infection at the block site, BMI >35 kg/m2, significant neurological/psychiatric disorders, or those who refuse the procedures are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, one or both blocks could reduce early postoperative pain, decrease opioid requirements, and speed recovery after laparoscopic cholecystectomy.
How similar studies have performed: Erector spinae plane (ESP) blocks have shown benefit in reducing postoperative pain and opioid use after abdominal and thoracic procedures, while EXORA is a newer regional technique with limited published direct-comparison data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Elective laparoscopic cholecystectomy * ASA physical status I-III Exclusion Criteria: * Known allergy to local anesthetics * Chronic pain or regular opioid use * Coagulopathy or anticoagulant therapy * Local infection at the block site * BMI more than 35 kg/m2 * Neurological or psychiatric disorders * Refusal to participate
Where this trial is running
El Fayoum Qesm, Faiyum Governorate
- 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: Khaled M Sayed, Bch
- Email: khaledm191170@gmail.com
- Phone: 1065444158
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.