Can a pulse oximeter detect pain relief in kids under anesthesia?
NCT ID NCT07703384
First seen Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time
Summary
This study looks at two non-invasive monitors—the perfusion index (PI) and the surgical pleth index (SPI)—to see which one detects a successful caudal block faster in children aged 1 to 6 years having lower belly surgery. A caudal block is a numbing injection near the tailbone that helps control pain after surgery. The goal is to find a reliable way to confirm the block is working while the child is under general anesthesia.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- caudal block (a regional anesthesia procedure)
- What this could lead to
- If successful, this could help anesthesiologists quickly confirm that a caudal block is working in children, reducing reliance on less reliable signs.
- What could go wrong
- This is a small observational study (40 children), so results may not apply broadly. The monitors' accuracy in children is still unclear.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
study will be conducted in Fayoum University hospital after the local Institutional Ethics Committee and local institutional review board approval. Inclusion criteria * Children aged 1 to 6 years of either sex * With American Society of Anesthesiologists (ASA) physical status I-II * undergoing elective infraumbilical surgery. Exclusion criteria * parental refusal * Patients with liver disease (e.g. elevated bilirubin \>2mg/dL, albumin\<3.0g/dL) * Patients with renal disease (e.g. serum creatinine \>1.5-2mg/dL) * Cardiac disorders (low EF\>50%, sever valvular heart disease) * Recent respiratory tract infection within 1-2 weeks and bronchial asthma * Known organic brain disease (cerebral palsy, tumors) * patients with any contraindication to caudal anesthesia (local infection, coagulation abnormality e.g. INR \> 1.5, known structural abnormality e.g. kyphosis) * Known allergy to local anesthetics.
- Ages
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1 year to 6 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * • Children aged 1 to 6 years of either sex * With American Society of Anesthesiologists (ASA) physical status I-II * undergoing elective infraumbilical surgery Exclusion Criteria: * • parental refusal * Patients with liver disease (e.g. elevated bilirubin \>2mg/dL, albumin\<3.0g/dL) * Patients with renal disease (e.g. serum creatinine \>1.5-2mg/dL) * Cardiac disorders (low EF\>50%, sever valvular heart disease) * Recent respiratory tract infection within 1-2 weeks and bronchial asthma * Known organic brain disease (cerebral palsy, tumors) * patients with any contraindication to caudal anesthesia (local infection, coagulation abnormality e.g. INR \> 1.5, known structural abnormality e.g. kyphosis) * Known allergy to local anesthetics
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fayoum University hospital
El Fayoum Qesm, Faiyum Governorate, 63514, Egypt