NCT07161375

Brief Summary

This study aims to evaluate the accuracy of temperature change (ΔT) measurements using infrared thermography to predict a successful erector spinae plane block in pediatric patients undergoing inguinal hernia repair under general anesthesia.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
69

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2024

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 Start

First participant enrolled

August 5, 2024

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2025

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 8, 2025

Completed
Last Updated

September 8, 2025

Status Verified

August 1, 2025

Enrollment Period

1.1 years

First QC Date

August 30, 2025

Last Update Submit

August 30, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Predict successful ESPB

    The ability to predict a successful erector spinae plane block by infrared thermography through the change in temperature (ΔT) (degrees Celsius) between the blocked and unblocked sides of the same dermatomal level in the mid-clavicular line throughout 20 minutes of block.

    Throughout 20 minutes of block

Secondary Outcomes (6)

  • Degree of pain

    12 hours after surgery

  • Heart rate

    Till discharge of the patient (Up to 12 hours)

  • Systolic blood pressure

    Till discharge of the patient (Up to 12 hours)

  • Mean arterial blood pressure

    Till discharge of the patient (Up to 12 hours)

  • Number of doses of rescue analgesia

    12 hours after surgery

  • +1 more secondary outcomes

Study Arms (1)

Study group

Children undergoing elective unilateral open inguinal hernia surgery.

Device: Infrared Thermography

Interventions

Infrared thermography will be used to predict the success of an erector spinae block by measuring the temperature difference between the blocked and unblocked sides.

Study group

Eligibility Criteria

Age3 Months - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The study will be conducted at Kasr Al Ainy, Abu El Reesh children hospital.

You may qualify if:

  • Age from 3 months to 6 years.
  • Both genders.
  • American Society of Anesthesiologists (ASA) Physical Status I-II.
  • Children undergoing elective unilateral open inguinal hernia surgery.

You may not qualify if:

  • Parents' or guardians' refusal
  • Known Allergy to local anesthetics.
  • Coagulopathy \[international normalised ratio (INR) \>1.4 or platelets \<75.000\].
  • Infection at the site of injection or wound close to the puncture site.
  • preexisting neuropathy (with sensory and/or motor deficits).
  • Diseases interfere with thermal imaging (as skin infections).
  • Baseline oesophageal body temperature of more than 37.5 °C.
  • Emergency and re-do cases will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, 12613, Egypt

RECRUITING

Central Study Contacts

Marwa A Abdelfatah, Master

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer of Anesthesia, Pain Management and surgical ICU, Faculty of Medicine, Cairo University, Cairo, Egypt.

Study Record Dates

First Submitted

August 30, 2025

First Posted

September 8, 2025

Study Start

August 5, 2024

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

September 8, 2025

Record last verified: 2025-08

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