External Oblique and Rectus Abdominis Plane (EXORA) Block for Postoperative Analgesia in Patients Undergoing Umbilical Hernia Repair

External Oblique and Rectus Abdominis Plane (EXORA) Block for Postoperative Analgesia in Patients Undergoing Umbilical Hernia Repair: A Randomized Controlled Trial

This study aims to evaluate the effect of the external oblique and rectus abdominis plane (EXORA) block for postoperative analgesia in patients undergoing umbilical hernia repair.

Study Overview

• Status: Completed
• Conditions: Postoperative Analgesia; External Oblique and Rectus Abdominis Plane; Umbilical Hernia Repair
• Intervention / Treatment: Other: External oblique and rectus abdominis plane (EXORA) block; Other: Sham block

Detailed Description

Umbilical hernias account for approximately 6-14% of adult abdominal wall hernias. These hernias are typically acquired and are mainly caused by increased abdominal pressure. Umbilical hernias do not heal on their own and usually require surgical intervention.

The external oblique and rectus abdominis plane (EXORA) block is an emerging technique providing a sensory block to the anterolateral abdominal wall. The EXORA block involves local anaesthetic injection into the fascial plane between the external oblique and rectus abdominis muscles. This method provides better dermatomal coverage, making the EXORA block particularly effective in the treatment of somatic pain in the anterolateral area of the upper and middle abdomen.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Tanta University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Age from 18 to 65 years.
• Both sexes.
• American Society of Anesthesiology (ASA) physical status I-II.
• Undergoing umbilical hernia repair.

Exclusion Criteria:

• History of allergies to local anesthetics.
• Bleeding or coagulation disorders.
• Anatomical abnormalities.
• Psychiatric and neurological disorders.
• Local infection at the site of injection.
• Complicated hernial defects [strangulated, incarcerated, or obstructed cases].

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
Experimental: EXORA block group; Patients will receive an external oblique and rectus abdominis plane (EXORA) block using 20 mL of bupivacaine 0.25%.	Other: External oblique and rectus abdominis plane (EXORA) block; Patients will receive an external oblique and rectus abdominis plane (EXORA) block using 20 mL of bupivacaine 0.25%.
Sham Comparator: Control group; Patients will receive a sham block using 20 mL of normal saline as a control group.	Other: Sham block; Patients will receive a sham block using 20 mL of normal saline as a control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total morphine consumption	Rescue analgesia of morphine will be given as 5 mg bolus if the numeric rating scale (NRS) > 3 to be repeated after 30 min if pain persists until the NRS < 4.	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative fentanyl consumption	Additional fentanyl bolus dosages of 1 µg/kg IV will be administered if heart rate or mean arterial blood pressure elevated more than 20% of the baseline (after exclusion of other causes than pain).	Intraoperatively
Time to the 1st rescue analgesia	Time to the first request for the rescue analgesia (time from the end of surgery to first dose of morphine administrated).	24 hours postoperatively
Degree of pain	Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS will be assessed at post-anesthesia care unit (PACU), 2, 4, 6, 8, 12, and 24 h postoperatively.	24 hours postoperatively
Mean arterial pressure	Mean arterial pressure will be recorded preoperatively and every 30 minutes till the end of surgery.	Till the end of surgery (Up to 2 hours)
Heart rate	Heart rate will be recorded preoperatively and every 30 minutes till the end of surgery.	Till the end of surgery (Up to 2 hours)
Incidence of adverse events	Incidence of adverse events such as bradycardia, hypotension, nausea, vomiting, respiratory depression, or any other complication will be recorded.	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2025
• Primary Completion (Actual): March 19, 2026
• Study Completion (Actual): March 19, 2026

Study Registration Dates

• First Submitted: May 31, 2025
• First Submitted That Met QC Criteria: May 31, 2025
• First Posted (Actual): June 10, 2025

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Infant, Newborn, Diseases; Hernia, Abdominal; Hernia, Ventral; Hernia; Hernia, Umbilical; Digestive System and Oral Physiological Phenomena; Dentistry; Dental Physiological Phenomena; Dental Occlusion
• Other Study ID Numbers: 36264PR1207/5/25

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