Low Versus Standard Volume EXORA Block in Laparoscopic Cholecystectomy

NCT07507799 | Not Yet Recruiting DMC

• 1 other identifier: M 871
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

The original EXORA block used high local anesthetic volume (50 mL total), raising concerns about local anesthetic systemic toxicity (LAST). In such a bilaterally administered regional technique, evaluating the efficacy of a reduced-volume approach is warranted to maximize patient safety.

Conditions

Pain, Postoperative; Post Operative Analgesia

Keywords

EXORA; analgesic efficacy; low volume; laparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (1)

• Dynamic numerical rating scale (NRS) score at 4 hours postoperatively.

  From 0 to 10 where 0 denote no pain and 10 denote the worst pain ever experienced with cough

  4 hours after surgery

Secondary Outcomes (13)

• Static Numerical Rating scale NRS scores

  up to 24 hours post operatively

• Dynamic numerical rating scale NRS scores

  up to 24 hours post operatively

• Cumulative Static Pain Burden

  Up to 24h postoperatively

• Cumulative Dynamic Pain Burden

  Up to 24h postoperatively

• Intraoperative Fentanyl consumption Total fentanyl in micrograms

  From induction of anesthesia until patient is transferred to postoperative care unit up to 4 hours]

Study Arms (2)

EXORA 15

ACTIVE COMPARATOR

15 mL of bupivacaine 0.25% administered bilaterally

Procedure: EXORA block 15

EXORA 25

ACTIVE COMPARATOR

25 mL of bupivacaine 0.25% administered bilaterally

Procedure: EXORA block 25

Interventions

EXORA block 15 PROCEDURE

15 mL of bupivacaine 0.25% administered bilaterally by ultrasound guided EXORA block

EXORA 15

EXORA block 25 PROCEDURE

25 mL of bupivacaine 0.25% administered bilaterally by ultrasound guided EXORA block

EXORA 25

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status I or II.
• Scheduled for elective laparoscopic cholecystectomy under general anesthesia.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (1)

Fayoum University hospital

El Fayoum Qesm, Faiyum Governorate, 63514, Egypt

Location

Related Publications (6)

• Okmen K, Demirel A, Dogan AK, Ertus CY. Application of EXORA block for analgesia following hand-assisted laparoscopic donor nephrectomy (HALDN). Indian J Anaesth. 2025 Mar;69(3):324-326. doi: 10.4103/ija.ija_1263_24. Epub 2025 Feb 17. No abstract available.

  PMID: 40161911 BACKGROUND

• Okmen K, Yildiz DK, Ulker GK. Evaluation of the efficacy of M-TAPA and EXORA block application for analgesia after laparoscopic cholecystectomy: a prospective, single-blind, observational study. Korean J Anesthesiol. 2025 Aug;78(4):361-368. doi: 10.4097/kja.24563. Epub 2025 Apr 15.

  PMID: 40230270 BACKGROUND

• Fernandez Martin MT, Lopez Alvarez S, Valdes-Vilches LF. EXORA block: a new approach for laparoscopic cholecystectomy analgesia? Minerva Anestesiol. 2024 May;90(5):462-463. doi: 10.23736/S0375-9393.23.17863-1. Epub 2024 Jan 29. No abstract available.

  PMID: 38287777 BACKGROUND

• Kumar K, Kirksey MA, Duong S, Wu CL. A Review of Opioid-Sparing Modalities in Perioperative Pain Management: Methods to Decrease Opioid Use Postoperatively. Anesth Analg. 2017 Nov;125(5):1749-1760. doi: 10.1213/ANE.0000000000002497.

  PMID: 29049119 BACKGROUND

• De Cassai A, Sella N, Geraldini F, Tulgar S, Ahiskalioglu A, Dost B, Manfrin S, Karapinar YE, Paganini G, Beldagli M, Luoni V, Ordulu BBK, Boscolo A, Navalesi P. Single-shot regional anesthesia for laparoscopic cholecystectomies: a systematic review and network meta-analysis. Korean J Anesthesiol. 2023 Feb;76(1):34-46. doi: 10.4097/kja.22366. Epub 2022 Nov 8.

  PMID: 36345156 BACKGROUND

• Ekstein P, Szold A, Sagie B, Werbin N, Klausner JM, Weinbroum AA. Laparoscopic surgery may be associated with severe pain and high analgesia requirements in the immediate postoperative period. Ann Surg. 2006 Jan;243(1):41-6. doi: 10.1097/01.sla.0000193806.81428.6f.

  PMID: 16371735 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Mohamed A Hamed,, MD

  Faculty of medicine, Fayoum university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammed R Gomaa, Bch

CONTACT

1097830069; mr147@fayoum.edu.eg

Mohamed H Ragab, MD

CONTACT

1090050298 Ext. +20; mhr02@fayoum.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: April 2, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 2, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)