Ultrasound Guided External Oblique and Rectus Abdominis Plane Block (EXORA) on Neuroendocrine Stress Response in Adults Undergoing Umbilical Hernia Surgery

The Effect of Ultrasound Guided External Oblique and Rectus Abdominis Plane Block (EXORA) on Neuroendocrine Stress Response in Adults Undergoing Umbilical Hernia Surgery: A Prospective Randomized Controlled Trial

This study aims to evaluate the efficacy of ultrasound-guided external oblique and rectus abdominis plane block on the neuroendocrine stress response and postoperative analgesia in adults undergoing umbilical hernia repair.

Study Overview

• Status: Recruiting
• Conditions: Umbilical Hernia; Ultrasound; External Oblique; Rectus Abdominis Plane Block; Neuroendocrine Stress Response
• Intervention / Treatment: Other: General anesthesia; Other: External oblique and rectus abdominis plane (EXORA) block

Detailed Description

Umbilical hernias of the abdomen are defined as a non-inguinal, non-hiatal defect in the fascia of the abdominal wall. Surgical stress response refers to the physiologic response to surgery and the hormonal and metabolic changes that follow it.

Fascial plane blocks are gaining attention for perioperative analgesia due to their efficacy and safety profiles. The external oblique and rectus abdominis plane (EXORA) block is an emerging technique that provides a sensory block to the anterolateral abdominal wall, potentially filling gaps left by other commonly used blocks, such as the quadratus lumborum (QLB) or erector spinae plane (ESP) blocks.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mayada H Sokeer, Master; Phone Number: 00201095315597; Email: mayada.hady@med.tanta.edu.eg

Study Locations

• Egypt
  • Tanta, Egypt, 31527
    • Recruiting
    • Tanta University
    • Sub-Investigator: Alaa M Abo Hagar, MD
    • Sub-Investigator: Nashwa E Hamoda, MD
    • Contact: Mayada H Sokeer, Master; Phone Number: 00201095315597; Email: mayada.hady@med.tanta.edu.eg
    • Sub-Investigator: Lobna M Khalil, MD
    • Sub-Investigator: Gehan M Morsy, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged from 21 to 65 years.
• Both sexes.
• American Society of Anesthesiologists (ASA) Physical status I and Ⅱ.
• Schedule for elective umbilical hernia surgery under general anesthesia.

Exclusion Criteria:

• ASA Ⅲ or Ⅳ.
• Patients with metabolic abnormalities, e.g., diabetes mellitus.
• Patients receiving corticosteroids.
• History of allergies to local anesthetics.
• Bleeding or coagulation disorders.
• Anatomical abnormalities.
• Psychiatric and neurological disorders.
• Complicated hernial defect (obstructed).
• Patient refusal.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group I; Patients will receive general anesthesia only.	Other: General anesthesia; Patients will receive general anesthesia only.
Experimental: Group Ⅱ; Patients will receive general anesthesia and an external oblique and rectus abdominis plane (EXORA) block with 0.25% bupivacaine.	Other: External oblique and rectus abdominis plane (EXORA) block; Patients will receive general anesthesia and an external oblique and rectus abdominis plane (EXORA) block with 0.25% bupivacaine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuroendocrine stress response	Neuroendocrine stress response will be measured by blood glucose level in adults undergoing umbilical hernia repair.	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum cortisol level	Serum cortisol level will be measured.	24 hours postoperatively
Time of first rescue analgesia	Time of first rescue analgesia will be recorded from the end of surgery till first dose of morphine administration.	24 hours postoperatively
Total intraoperative fentanyl consumption	Rescue dose of intraoperative fentanyl given will be recorded.	Intraoperatively
Total morphine consumption	Intravenous morphine (rescue analgesic) at a dosage of 3 mg will be administered when the Numerical Rating Scale (NRS) score will be ≥ 4. The total morphine consumption over a 24-hours period will be recorded for these individuals.	24 hours postoperatively
Degree of pain	Each patient will be instructed in postoperative pain assessment using the Numerical Rating Scale (NRS), ranging from 0 to 10 (0 = "no pain," 10 = "the worst pain imaginable"). NRS will be assessed at post-anesthesia care unit (PACU),1,2,4,6,12,24 hours postoperative	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: December 23, 2025
• First Submitted That Met QC Criteria: December 23, 2025
• First Posted (Actual): January 8, 2026

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Infant, Newborn, Diseases; Hernia; Hernia, Abdominal; Hernia, Ventral; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Hernia, Umbilical; Anesthesia and Analgesia; Digestive System and Oral Physiological Phenomena; Anesthesia; Dentistry; Dental Physiological Phenomena; Dental Occlusion; Anesthesia, General
• Other Study ID Numbers: 36265MD474/10/25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No