InfraredNCT07161375
Infrared Thermography for Prediction of Successful Erector Spinae Plane Block in Unilateral Inguinal Hernia Surgery in Paediatric Patients
An observational study of Infrared and Thermography, run by Cairo University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 3 months to 6 years
- Conditions the study is for
- Infrared, Thermography, Prediction
- What is being tested?
- Infrared Thermography
- Type of treatment
- Medical device
- How many people
- 69 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Aug 2024to 1 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: The study will be conducted at Kasr Al Ainy, Abu El Reesh children hospital.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, 12613
Marwa A Abdelfatah, Master, 00201065276941, Marote7a@gmail.com
Maha G Hanna, MD
About this study
Official title: Infrared Thermography for Prediction of Successful Erector Spinae Plane Block in Unilateral Inguinal Hernia Surgery in Paediatric Patients: A Prospective Observational Study
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.
- Conditions
- Infrared, Thermography, Prediction, Erector Spinae Plane Block, Unilateral Inguinal Hernia Surgery, Paediatric
- Being tested
- Infrared Thermography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infrared ThermographyDevice
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 | Role | What they receive |
|---|---|---|
| Study group | Children undergoing elective unilateral open inguinal hernia surgery. Receives: Device: Infrared Thermography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Throughout 20 minutes of block
Secondary outcomes (6)
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.
Measured: 12 hours after surgery
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.
Measured: Till discharge of the patient (Up to 12 hours)
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.
Measured: Till discharge of the patient (Up to 12 hours)
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.
Measured: Till discharge of the patient (Up to 12 hours)
Number of doses of rescue analgesia
Number of doses of rescue analgesia will be recorded.
Measured: 12 hours after surgery
Incidence of adverse events
Incidence of adverse events will be recorded.
Measured: 12 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start5 Aug 2024
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfraredStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Abdelfatah Abdelrahman Abdelfatah, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07161375
- Sponsor's protocol ID
- MD-210-2024
- Status last verified
- Aug 2025
- First submitted
- 30 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infrared Thermography for Prediction of Successful Erector Spinae Plane Block in Unilateral Inguinal Hernia Surgery in Paediatric Patients: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07161375
- Acronym / sponsor ID
- MD-210-2024
- Conditions
- Infrared, Thermography, Prediction, Erector Spinae Plane Block, Unilateral Inguinal Hernia Surgery, Paediatric
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Device: Infrared ThermographyChildren undergoing elective unilateral open inguinal hernia surgery. |
Who may qualify
- Ages
- 3 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study will be conducted at Kasr Al Ainy, Abu El Reesh children hospital.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infrared ThermographyInfrared thermography will be used to predict the success of an erector spinae block by measuring the temperature difference between the blocked and unblocked sides. | Device | Study group |
Primary outcome
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.
6 secondary outcomes
Degree of pain
Time frame: 12 hours after surgery
Heart rate
Time frame: Till discharge of the patient (Up to 12 hours)
Systolic blood pressure
Time frame: Till discharge of the patient (Up to 12 hours)
Mean arterial blood pressure
Time frame: Till discharge of the patient (Up to 12 hours)
Number of doses of rescue analgesia
Time frame: 12 hours after surgery
Incidence of adverse events
Time frame: 12 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infrared and Thermography, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marwa A Abdelfatah, Master (00201065276941, Marote7a@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predict successful ESPB (time frame: Throughout 20 minutes of block). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.