External Oblique and Rectus Abdominis Plane (EXORA) Block for Postoperative Analgesia in Patients Undergoing Umbilical Hernia Repair
1 other identifier
interventional
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2025
CompletedFirst Posted
Study publicly available on registry
June 10, 2025
CompletedStudy Start
First participant enrolled
June 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 19, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 19, 2026
CompletedApril 22, 2026
April 1, 2026
9 months
May 31, 2025
April 21, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Time to the 1st rescue analgesia
24 hours postoperatively
Intraoperative fentanyl consumption
Intraoperatively
Degree of pain
24 hours postoperatively
Mean arterial pressure
Till the end of surgery (Up to 2 hours)
Heart rate
Till the end of surgery (Up to 2 hours)
- +1 more secondary outcomes
Study Arms (2)
EXORA block group
EXPERIMENTALPatients will receive an external oblique and rectus abdominis plane (EXORA) block using 20 mL of bupivacaine 0.25%.
Control group
SHAM COMPARATORPatients will receive a sham block using 20 mL of normal saline as a control group.
Interventions
Patients will receive an external oblique and rectus abdominis plane (EXORA) block using 20 mL of bupivacaine 0.25%.
Patients will receive a sham block using 20 mL of normal saline as a control group.
Eligibility Criteria
You may qualify if:
- Age from 18 to 65 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I-II.
- Undergoing umbilical hernia repair.
You may not qualify if:
- 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 \[strangulated, incarcerated, or obstructed cases\].
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tanta Universitylead
Study Sites (1)
Tanta University
Tanta, El-Gharbia, 31527, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.
Study Record Dates
First Submitted
May 31, 2025
First Posted
June 10, 2025
Study Start
June 10, 2025
Primary Completion
March 19, 2026
Study Completion
March 19, 2026
Last Updated
April 22, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- After the end of study for one year.
- Access Criteria
- The data will be available upon a reasonable request from the corresponding author.
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.