NCT07012603

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 10, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

June 10, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2026

Completed
Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

9 months

First QC Date

May 31, 2025

Last Update Submit

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

EXPERIMENTAL

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

Control group

SHAM COMPARATOR

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

Other: Sham block

Interventions

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

EXORA block group

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

Control group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Interventions

Dental Occlusion

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

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

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

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.

Locations