NCT07324863

Brief Summary

This study aims to evaluate the efficacy of ultrasound-guided external oblique and rectus abdominis plane block on the neuroendocrine stress response and postoperative analgesia in adults undergoing umbilical hernia repair.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress71%
Aug 2025Sep 2026

Study Start

First participant enrolled

August 1, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 8, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

January 8, 2026

Status Verified

December 1, 2025

Enrollment Period

1.1 years

First QC Date

December 23, 2025

Last Update Submit

December 23, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Neuroendocrine stress response

    Neuroendocrine stress response will be measured by blood glucose level in adults undergoing umbilical hernia repair.

    24 hours postoperatively

Secondary Outcomes (5)

  • Serum cortisol level

    24 hours postoperatively

  • Time of first rescue analgesia

    24 hours postoperatively

  • Total intraoperative fentanyl consumption

    Intraoperatively

  • Total morphine consumption

    24 hours postoperatively

  • Degree of pain

    24 hours postoperatively

Study Arms (2)

Group I

ACTIVE COMPARATOR

Patients will receive general anesthesia only.

Other: General anesthesia

Group Ⅱ

EXPERIMENTAL

Patients will receive general anesthesia and an external oblique and rectus abdominis plane (EXORA) block with 0.25% bupivacaine.

Other: External oblique and rectus abdominis plane (EXORA) block

Interventions

Patients will receive general anesthesia only.

Group I

Patients will receive general anesthesia and an external oblique and rectus abdominis plane (EXORA) block with 0.25% bupivacaine.

Group Ⅱ

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged from 21 to 65 years.
  • Both sexes.
  • American Society of Anesthesiologists (ASA) Physical status I and Ⅱ.
  • Schedule for elective umbilical hernia surgery under general anesthesia.

You may not qualify if:

  • ASA Ⅲ or Ⅳ.
  • Patients with metabolic abnormalities, e.g., diabetes mellitus.
  • Patients receiving corticosteroids.
  • History of allergies to local anesthetics.
  • Bleeding or coagulation disorders.
  • Anatomical abnormalities.
  • Psychiatric and neurological disorders.
  • Complicated hernial defect (obstructed).
  • Patient refusal.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, 31527, Egypt

RECRUITING

MeSH Terms

Conditions

Hernia, Umbilical

Interventions

Anesthesia, GeneralDental Occlusion

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHernia, VentralHernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and AnalgesiaDentistryDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Central Study Contacts

Mayada H Sokeer, Master

CONTACT

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
Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

First Submitted

December 23, 2025

First Posted

January 8, 2026

Study Start

August 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

January 8, 2026

Record last verified: 2025-12

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