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RecruitingNCT07161375Updated Sep 8, 2025

Infrared Thermography for Prediction of Successful Erector Spinae Plane Block in Unilateral Inguinal Hernia Surgery in Paediatric Patients

An observational study in Infrared, Thermography and Prediction, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 3 Months to 6 Years. Per ClinicalTrials.gov, last updated 2025-09-08.

Sponsored by Cairo University · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
  • Started Aug 2024; still recruiting 2 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
69
Ages
3 Months to 6 Years
Sex
All
01

Study 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.

Read the detailed description

Lower abdominal surgeries, including inguinal hernia repair, have been performed extensively in the daily practice of pediatric surgeries, so ensuring sufficient intra- and post-operative analgesia is crucial for perioperative care.

The ultrasound-guided erector spinae plane block (ESPB) is a regional anesthetic technique. Early detection of successful ESPB in pediatric patients will enable the application of rescue techniques at the appropriate time, thereby improving patient satisfaction and reducing operating theatre time.

There is considerable evidence regarding the value of infrared thermography in predicting successful nerve blocks. Infrared thermography is the process of using a thermal image to detect radiation (heat) coming from an object, converting it to temperature, and displaying an image of the temperature distribution.

02

Conditions studied

  • Infrared
  • Thermography
  • Prediction
  • Erector Spinae Plane Block
  • Unilateral Inguinal Hernia Surgery
  • Paediatric
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Months to 6 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
69 participants (estimated)
Patient registry
No

Groups and cohorts

  • Study group

    Children undergoing elective unilateral open inguinal hernia surgery.

    Device: Infrared Thermography

Interventions

  • DeviceInfrared Thermography

    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.

06

What researchers measure

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.

    Time frame: Throughout 20 minutes of block

Secondary outcomes

  1. Degree of pain

    Degree of pain will be assessed using Face, Legs, Activity, Cry, and Consolability (FLACC) score. Each category is scored from 0 to 2, resulting in a total pain score from 0 to 10, where 0 indicates no pain and higher scores represent increasing pain levels. FLACC will be recorded at 15, 30, 45 and 60 min, 6 and 12 hours after surgery.

    Time frame: 12 hours after surgery

  2. Heart rate

    Heart rate will be recorded 5 min after intubation, then every 5 min after block 5,10,15, and 20 min, then at skin incision, immediately after extubation, 15 min after extubation, and every 15 minutes in the post-anesthesia care unit (PACU) (30,45, and 60 minutes) till discharge of the patient.

    Time frame: Till discharge of the patient (Up to 12 hours)

  3. Systolic blood pressure

    Systolic blood pressure will be recorded 5 min after intubation, then every 5 min after block 5,10,15, and 20 min, then at skin incision, immediately after extubation, 15 min after extubation, and every 15 minutes in the post-anesthesia care unit (PACU) (30,45, and 60 minutes) till discharge of the patient.

    Time frame: Till discharge of the patient (Up to 12 hours)

  4. Mean arterial blood pressure

    Mean arterial blood pressure will be recorded 5 min after intubation, then every 5 min after block 5,10,15, and 20 min, then at skin incision, immediately after extubation, 15 min after extubation, and every 15 minutes in the post-anesthesia care unit (PACU) (30,45, and 60 minutes) till discharge of the patient.

    Time frame: Till discharge of the patient (Up to 12 hours)

  5. Number of doses of rescue analgesia

    Number of doses of rescue analgesia will be recorded.

    Time frame: 12 hours after surgery

  6. Incidence of adverse events

    Incidence of adverse events will be recorded.

    Time frame: 12 hours after surgery

07

Study locations

1 of 1 sites recruiting
  • Cairo University
    Cairo, 12613, Egypt
    • Marwa A Abdelfatah, Master · Contact · Marote7a@gmail.com · 00201065276941
    • Maha G Hanna, MD · Sub investigator
    • Mohamed M Anwar, MD · Sub investigator
    • Islam R Abdelfatah, MD · Sub investigator
    • Shimaa M Ahmed, MD · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07161375
Lead sponsor
Cairo University
Responsible party
Marwa Abdelfatah Abdelrahman Abdelfatah (Assistant Lecturer of Anesthesia, Pain Management and surgical ICU, Faculty of Medicine, Cairo University, Cairo, Egypt., Cairo University) — Principal investigator
First posted
Sep 8, 2025
Start date
Aug 5, 2024
Primary completion
Sep 1, 2025 (estimated)
Completion
Sep 1, 2025 (estimated)
Last update
Sep 8, 2025

Study contacts

Marwa A Abdelfatah, Master
Contact
Marote7a@gmail.com
00201065276941

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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