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Comparison of The Perfusion Index and The Surgical Pleth Index in Detecting The Effectiveness of Caudal Block in Pediatrics

NCT07703384 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2026-07-14

No results posted yet for this study

Summary

Caudal block is a common method of regional anesthesia. In pediatrics, it works as a supplement to general anesthesia and is a good method for control postoperative pain. By offering superior analgesia, it decreases the use for intravenous opioids, thereby reducing related adverse reactions like nausea, vomiting, and respiratory impairment. Consequently, caudal block is a safe and appropriate method for managing pain in children undergoing different types of surgery. Usually, it is given following general anesthesia in children, making a some difficulty in evaluating the block's effectiveness The success of a caudal block is traditionally predicted by hemodynamic changes in blood pressure and heart rate, although these variables are thought to be unreliable, many tests, like 'swoosh' and 'whoosh' tests, and ultrasonography, can be used to guarantee precise needle placement and enhance the probability of block success.

Other variables are sometimes used, such as laxity of the anal sphincter tone and loss of the cremasteric reflex; however under general anesthesia, their dependability is doubtful and the latter can only be used for male children . Technological developments in pulse oximeters have improved their capacity to monitor other parameters, such as the surgical pleth index (SPI) and perfusion index (PI).

Perfusion index (PI) is a non-invasive numerical evaluation of the pulsatile strength at a monitoring site that offers helpful data regarding the patient's peripheral perfusion status .

Local vasoconstriction may induce a decrease in PI, whereas vasodilatation causes an increase in PI in the skin at the monitoring site Successful anesthesia onset is indicated by an increase in PI, but failure to do so may be indicated by a lack of increase.

Surgical pleth index (SPI) is another noninvasive, dimensionless score whose value is derived from pulse wave amplitude and heartbeat interval as measured by a pulse oximetry probe The sympathetic reaction of the patient to the surgical stimulus is reflected in SPI , research on SPI indicates that adults with values between 20 and 50 have good nociception, but its usefulness in children is unclear.

The aim of this study This study aims to determine the time to change of value of PI and SPI in assessing the effectiveness of a caudal block in pediatric patients during infraumbilical surgeries under general anesthesia

Conditions

  • The Success of Caudal Block

Interventions

PROCEDURE

caudal block

Three minutes after anesthesia induction the patient will be positioned in the lateral decubitus position, a caudal block will be performed using the landmark technique under aseptic conditions. After carful preparing and cleaning the area using 10% povidone-iodine, the sacral hiatus will be identified, a 22G, 1 to 1.5 inch hypodermic needle will be inserted until the sacro-coccygeal ligament will be pierced a distinct "pop" indicated entry into the caudal space, a test dose of lidocaine 1% with epinephrine (1:200,000) will be administered at a dose of 0.5 mL/kg (maximum 3 mL) to exclude inadvertent intravascular or intrathecal injection. After confirming negative aspiration for blood or cerebrospinal fluid (CSF) then a 0.25% bupivacaine (1 mL/kg) will be injected at a rate of 1 mL per 3 seconds. The patient will be immediately repositioned supine; The surgical incision will be made approximately 10 min after caudal block administration.

Sponsors & Collaborators

  • Fayoum University Hospital

    lead OTHER

Principal Investigators

  • Safaa G Ragab, MD · Faculty of medicine, Fayoum university

Eligibility

Min Age
1 Year
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-06
Primary Completion
2027-07-06
Completion
2027-07-06

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07703384 on ClinicalTrials.gov