Low Versus Standard Volume EXORA Block in Laparoscopic Cholecystectomy

April 13, 2026 updated by: Mohamed Ahmed Hamed, Fayoum University Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Study Design & Population This is a prospective, randomized, double-blinded trial enrolling patients scheduled for elective laparoscopic cholecystectomy. Following informed consent, patients will be randomly allocated into two equal groups to evaluate different volumes used in a bilateral, ultrasound-guided External Oblique and Rectus Abdominis (EXORA) block.

Interventions Prior to the induction of general anesthesia, patients will receive a bilateral EXORA block using 0.25% bupivacaine.

Group E15: Will receive 15 mL of the local anesthetic on each side. Group E25: Will receive 25 mL of the local anesthetic on each side. Blinding & Allocation Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes. The block will be performed by a designated regional anesthesiologist who will not be involved in subsequent patient care. The patient, the surgical team, the intraoperative anesthesiologist, and the postoperative data collectors will remain strictly blinded to the group allocation and the volume injected.

Anesthesia & Perioperative Management Sensory block distribution will be assessed prior to surgery. All patients will receive a standardized general anesthesia protocol for induction and maintenance. Intraoperative hemodynamics will be managed according to standard institutional protocols.

Postoperative Analgesia & Monitoring Upon transfer to the Post-Anesthesia Care Unit (PACU) and throughout the first 24 hours, all patients will receive scheduled, standardized multimodal analgesia (intravenous paracetamol and ketorolac). Postoperative pain will be assessed using the 11-point Numerical Rating Scale (NRS) at rest and during movement at prespecified time points. If the dynamic NRS score is ≥ 4, intravenous morphine (2 mg) will be administered . Patients will be continuously monitored for adverse events, including postoperative nausea and vomiting (PONV), hemodynamic instability, and local anesthetic systemic toxicity (LAST), which will be managed with predefined rescue medications

Study Type

Interventional

Enrollment (Estimated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Faiyum Governorate
      • El Fayoum Qesm, Faiyum Governorate, Egypt, 63514
        • Fayoum University hospital
        • Contact:
        • Principal Investigator:
          • Mohamed A Hamed, MD
        • Contact:
        • Sub-Investigator:
          • Omar S Farghaly, MD
        • Sub-Investigator:
          • Mohamed H Ragab, MD
        • Sub-Investigator:
          • Mohammed R Gomaa, Bch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: EXORA 15
15 mL of bupivacaine 0.25% administered bilaterally
Procedure: EXORA block 15
15 mL of bupivacaine 0.25% administered bilaterally by ultrasound guided EXORA block
Active Comparator: EXORA 25
25 mL of bupivacaine 0.25% administered bilaterally
Procedure: EXORA block 25
25 mL of bupivacaine 0.25% administered bilaterally by ultrasound guided EXORA block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dynamic numerical rating scale (NRS) score at 4 hours postoperatively.
Time Frame: 4 hours after surgery
From 0 to 10 where 0 denote no pain and 10 denote the worst pain ever experienced with cough
4 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Static Numerical Rating scale NRS scores
Time Frame: up to 24 hours post operatively
From 0 to 10 where 0 denote no pain and 10 denote the worst pain ever experienced At predefined time points.(1,2,4,6,12 and 24 hours post operatively
up to 24 hours post operatively
Dynamic numerical rating scale NRS scores
Time Frame: up to 24 hours post operatively
From 0 to 10 where 0 denote no pain and 10 denote the worst pain ever experienced With cough at predefined time points.(1,2,6,12 and 24 hours post operatively
up to 24 hours post operatively
Cumulative Static Pain Burden
Time Frame: Up to 24h postoperatively
calculated as the Area Under the Curve (AUC) of Static NRS scores over the 24-hour postoperative period
Up to 24h postoperatively
Cumulative Dynamic Pain Burden
Time Frame: Up to 24h postoperatively
calculated as the Area Under the Curve (AUC) of Dynamic NRS scores over the 24-hour postoperative period
Up to 24h postoperatively
Intraoperative Fentanyl consumption Total fentanyl in micrograms
Time Frame: From induction of anesthesia until patient is transferred to postoperative care unit up to 4 hours]
Total fentanyl in micrograms
From induction of anesthesia until patient is transferred to postoperative care unit up to 4 hours]
Total cumulative consumption of intravenous morphine over the first 24 hours.
Time Frame: At 24 hours postoperatively
total morphine used in milligrams post operatively over 24 hours.
At 24 hours postoperatively
Time to first rescue analgesia
Time Frame: Upon recovery from General anesthesia up to 24 hours postoperatively]
Time to first request of rescue analgesia in hours
Upon recovery from General anesthesia up to 24 hours postoperatively]
Sensory block distribution level (pin-prick test)
Time Frame: At 30 minuets from the block
After 30 minutes of the block, assessed at. Midclavicular and Midaxillary lines from T5 to T12 level by a blinded anesthesiologist
At 30 minuets from the block
Quality of recovery score (QoR-15) at 24 hours.
Time Frame: At 24 hours postoperatively
scores range from 0 to 150, with a higher score indicating a better quality of postoperative recovery.
At 24 hours postoperatively
Incidence of adverse events: bradycardia, hypotension, PONV, and LAST.
Time Frame: From induction of anesthesia up to 24 hours postoperatively
Assessment of each patient looking for any of adverse effects as bradycardia ,hypotension, nausea, vomiting and LAST.
From induction of anesthesia up to 24 hours postoperatively
Heart rate
Time Frame: Upon arrival to Operating Room until 24 hours postoperative
Heart rate measured at Baseline (T0), 3 minutes post-intubation (T1), 1 minute post-skin incision (T2), 5 minutes after pneumoperitoneum inflation (T3), At extubation (T4) and postoperatively upon arrival in the PACU (0 hours), 1, 2, 4, 6, 12, and 24 hours
Upon arrival to Operating Room until 24 hours postoperative
Mean arterial pressure
Time Frame: Upon arrival to Operating Room until 24 hours postoperative
Mean arterial pressure measured at Baseline (T0), 3 minutes post-intubation (T1), 1 minute post-skin incision (T2), 5 minutes after pneumoperitoneum inflation (T3), At extubation (T4) and postoperatively upon arrival in the PACU (0 hours), 1, 2, 4, 6, 12, and 24 hours
Upon arrival to Operating Room until 24 hours postoperative
Ramsay Sedation Scale (RSS)
Time Frame: up to 24 hours
from 1 to 6 where 1 denotes anxious/agitated and 6 denotes deep sedation with no response to stimuli (6) assessed postoperative (at 1, 2, 4, 6, 12, and 24 hours)
up to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fayoum University Hospital

Investigators

  • Principal Investigator: Mohamed A Hamed,, MD, Faculty of medicine, Fayoum university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 10, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 2, 2026

Study Registration Dates

First Submitted

March 25, 2026

First Submitted That Met QC Criteria

March 30, 2026

First Posted (Actual)

April 2, 2026

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M 871

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain, Postoperative

Clinical Trials on EXORA block 15

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe