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

Not Applicable

Recruiting

• Conditions: External Oblique and Rectus Abdominis Plane; Postoperative Analgesia; Umbilical Hernia Repair

• Registration Number: NCT07012603
• Lead Sponsor: Tanta University

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.

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 Timeline

• Study First Submitted: 2025-05-31
• Study First Submitted QC: 2025-05-31
• Status Verified: 2025-06
• Study Start: 2025-06-10
• Study First Posted: 2025-06-10
• Last Update Submitted: 2025-06-10
• Last Update Posted: 2025-06-11
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Total morphine consumption	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 Outcome Measures

Name	Time	Method
Degree of pain	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.
Mean arterial pressure	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.
Heart rate	Till the end of surgery (Up to 2 hours)	Heart rate will be recorded preoperatively and every 30 minutes till the end of surgery.
Incidence of adverse events	24 hours postoperatively	Incidence of adverse events such as bradycardia, hypotension, nausea, vomiting, respiratory depression, or any other complication will be recorded.
Time to the 1st rescue analgesia	24 hours postoperatively	Time to the first request for the rescue analgesia (time from the end of surgery to first dose of morphine administrated).
Intraoperative fentanyl consumption	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).

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt