NCT07601945

Brief Summary

This study aimed to compare the analgesic efficacy of the external oblique intercostal fascial plane block (EOIPB) versus the rectus sheath block (RSB) for managing postoperative pain following paraumbilical hernioplasty.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2023

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

Study Start

First participant enrolled

May 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2026

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
Last Updated

May 22, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

April 26, 2026

Last Update Submit

May 15, 2026

Conditions

Keywords

External Oblique Intercostal Fascial Plane BlockRectus Sheath BlockPain

Outcome Measures

Primary Outcomes (2)

  • Total postoperative morphine consumption in milligrams during the first 24 hours after surgery

    Total cumulative morphine requirement administered for postoperative analgesia during the first 24 hours following paraumbilical hernia repair surgery, measured in milligrams (mg).

    First 24 hours postoperatively

  • Number of participants experiencing block-related or postoperative complications within 3 months after surgery

    Assessment of postoperative and block-related complications including local anesthetic toxicity, hematoma, infection, nausea/vomiting, respiratory depression, and other adverse events recorded during the follow-up period.

    3 months after surgery

Study Arms (2)

external oblique intercostal fascial plane block

EXPERIMENTAL

external oblique intercostal fascial plane block

Procedure: External Oblique Intercostal Fascial Plane Block for Postoperative Analgesia

rectus sheath block

ACTIVE COMPARATOR

rectus sheath block

Procedure: External Oblique Intercostal Fascial Plane Block for Postoperative Analgesia

Interventions

After the induction of general anesthesia and approximately 15 minutes before the surgical incision, patients were randomly assigned to receive either the EOIPB (Group A) or the RSB (Group B).

external oblique intercostal fascial plane blockrectus sheath block

Eligibility Criteria

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

You may qualify if:

  • Patients aged 18-65 years, classified as American Society of Anesthesiologists (ASA) physical status I or II \[16\], and scheduled for elective paraumbilical hernioplasty.

You may not qualify if:

  • Patients with a history of prolonged opioid medication, allergy to local anesthetics, pregnancy, infection at the injection site, and/or coagulopathy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helwan university

Giza, Giza Governorate, 3030, Egypt

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This prospective, randomized, single-blinded study enrolled 60 patients, divided into two groups (EOIPB and RSB), each comprising 30 participants
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

April 26, 2026

First Posted

May 22, 2026

Study Start

May 1, 2023

Primary Completion

April 30, 2025

Study Completion

June 30, 2025

Last Updated

May 22, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations