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Completed

NCT Number: NCT07012603

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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].

Treatment and study plan

External oblique and rectus abdominis plane (EXORA) block

Other

Patients will receive an external oblique and rectus abdominis plane (EXORA) block using 20 mL of bupivacaine 0.25%.

sham block

Other

Patients will receive a sham block using 20 mL of normal saline as a control group.

Primary outcomes

  1. Total morphine consumption

    Time frame: 24 hours postoperatively

    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.

Secondary outcomes

  1. Time to the 1st rescue analgesia

    Time frame: 24 hours postoperatively

    Time to the first request for the rescue analgesia (time from the end of surgery to first dose of morphine administrated).

  2. Intraoperative fentanyl consumption

    Time frame: Intraoperatively

    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).

  3. Degree of pain

    Time frame: 24 hours postoperatively

    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.

  4. Mean arterial pressure

    Time frame: Till the end of surgery (Up to 2 hours)

    Mean arterial pressure will be recorded preoperatively and every 30 minutes till the end of surgery.

  5. Heart rate

    Time frame: Till the end of surgery (Up to 2 hours)

    Heart rate will be recorded preoperatively and every 30 minutes till the end of surgery.

  6. Incidence of adverse events

    Time frame: 24 hours postoperatively

    Incidence of adverse events such as bradycardia, hypotension, nausea, vomiting, respiratory depression, or any other complication will be recorded.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 10, 2025
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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