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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-6
SponsorFayoum University Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• Children aged 1 to 6 years of either sex

With American Society of Anesthesiologists (ASA) physical status I-II

undergoing elective infraumbilical surgery

Disqualifiers

• 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)

Trial population

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.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • caudal block

    Procedure/Surgery

    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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Children aged 1 to 6 years of either sex With ASA I-II undergoing elective infra umbilical surgery.1 intervention

Trial outcomes

Primary outcomes

1

Time to change of value of PI and SPI after caudal block

The primary outcome is the difference in time to change between the Perfusion Index (PI) and the Surgical Pleth Index (SPI) following caudal block

Time frame
every minute for 10 minutes after caudal block as well as at skin incision then every 5 minutes for 30 minutes

Secondary outcomes

1

The recorded values of PI, SPI, HR and MAP

The recorded values of PI, SPI, HR and MAP in assessing the effectiveness of a caudal block in pediatric patients during infraumbilical surgeries under general anesthesia

Time frame
at baseline after induction just before caudal then every minute for 10 minutes after caudal block as well as at skin incision then every 5 minutes for 30 minutes
2

ROC curve of PI, SPI, HR and MAP

ROC curve of PI, SPI, HR and MAP

Time frame
every minute for 10 minutes after caudal block as well as at skin incision then every 5 minutes for 30 minutes
3

AUC of PI, SPI, HR and MAP

AUC of PI, SPI, HR and MAP

Time frame
every minute for 10 minutes after caudal block as well as at skin incision then every 5 minutes for 30 minutes
4

Best cut of value of PI, SPI, HR and MAP

Best cut of value of PI, SPI, HR and MAP in assessing the effectiveness of a caudal block in pediatric patients during infraumbilical surgeries under general anesthesia

Time frame
every minute for 10 minutes after caudal block as well as at skin incision then every 5 minutes for 30 minutes

Other outcomes

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