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NCT Number: NCT07161375

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

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.

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Key information

Conditions

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

Age range

3 month–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cairo University

Cairo, 12613, Egypt

Location status: Recruiting

Location contact

Islam R Abdelfatah, MD

SUB_INVESTIGATOR

Maha G Hanna, MD

SUB_INVESTIGATOR

Marwa A Abdelfatah, Master

CONTACT

[email protected]

00201065276941

Mohamed M Anwar, MD

SUB_INVESTIGATOR

Shimaa M Ahmed, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Infrared Thermography

Device

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.

Primary outcomes

  1. Predict successful ESPB

    Time frame: Throughout 20 minutes of block

    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.

Secondary outcomes

  1. Degree of pain

    Time frame: 12 hours after surgery

    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.

  2. Heart rate

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

    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.

  3. Systolic blood pressure

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

    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.

  4. Mean arterial blood pressure

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

    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.

  5. Number of doses of rescue analgesia

    Time frame: 12 hours after surgery

    Number of doses of rescue analgesia will be recorded.

  6. Incidence of adverse events

    Time frame: 12 hours after surgery

    Incidence of adverse events will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Marwa A Abdelfatah, Master

CONTACT

[email protected]

00201065276941

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Infrared Thermography for Prediction of Successful Erector Spinae Plane Block in Unilateral Inguinal Hernia Surgery in Paediatric Patients: A Prospective Observational Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 8, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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