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

NCT07703384 | Not Yet Recruiting

• 1 other identifier: D490
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Caudal Block; Perfusion Index; Pediatric Patients

Outcome Measures

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

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

Secondary Outcomes (5)

• The recorded values of PI, SPI, HR and MAP

  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

• ROC curve of PI, SPI, HR and MAP

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

• AUC of PI, SPI, HR and MAP

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

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

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

• Sensitivity and specificity of PI, SPI, HR and MAP

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

Study Arms (1)

Children aged 1 to 6 years of either sex With ASA I-II undergoing elective infra umbilical surgery.

Children aged 1 to 6 years of either sex With ASA I-II undergoing elective infra umbilical surgery .will receive caudal block

Procedure: caudal block

Interventions

caudal block PROCEDURE

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.

Children aged 1 to 6 years of either sex With ASA I-II undergoing elective infra umbilical surgery.

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Children aged 1 to 6 years of either sex
• With American Society of Anesthesiologists (ASA) physical status I-II
• undergoing elective infraumbilical surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (1)

Fayoum University hospital

El Fayoum Qesm, Faiyum Governorate, 63514, Egypt

Location

Related Publications (11)

• M. El-Sonbaty and A. El-Sonbaty, "Evaluation of Perfusion index (PI) efficiency in pediatriccaudal block: Is it the time to depend on PI," Med J Cairo Univ, vol. 83, pp. 223-227, 2015

  BACKGROUND

• Orme RM, Berg SJ. The 'swoosh' test--an evaluation of a modified 'whoosh' test in children. Br J Anaesth. 2003 Jan;90(1):62-5.

  PMID: 12488381 BACKGROUND

• Huiku M, Uutela K, van Gils M, Korhonen I, Kymalainen M, Merilainen P, Paloheimo M, Rantanen M, Takala P, Viertio-Oja H, Yli-Hankala A. Assessment of surgical stress during general anaesthesia. Br J Anaesth. 2007 Apr;98(4):447-55. doi: 10.1093/bja/aem004. Epub 2007 Feb 28.

  PMID: 17329347 BACKGROUND

• Bejugama S, Khatavkar SS. Perfusion index as primary predictor of successful caudal block in infraumbilical and lower limb pediatric surgeries: A prospective observational study. Saudi J Anaesth. 2025 Oct-Dec;19(4):594-599. doi: 10.4103/sja.sja_379_25. Epub 2025 Sep 3.

  PMID: 40994509 BACKGROUND

• Ginosar Y, Weiniger CF, Meroz Y, Kurz V, Bdolah-Abram T, Babchenko A, Nitzan M, Davidson EM. Pulse oximeter perfusion index as an early indicator of sympathectomy after epidural anesthesia. Acta Anaesthesiol Scand. 2009 Sep;53(8):1018-26. doi: 10.1111/j.1399-6576.2009.01968.x. Epub 2009 Apr 24.

  PMID: 19397502 BACKGROUND

• Park SG, Lee OH, Park YH, Shin HY, Kang H, Baek CW, Jung YH, Woo YC. The changes of non-invasive hemoglobin and perfusion index of Pulse CO-Oximetry during induction of general anesthesia. Korean J Anesthesiol. 2015 Aug;68(4):352-7. doi: 10.4097/kjae.2015.68.4.352. Epub 2015 Jul 28.

  PMID: 26257847 BACKGROUND

• Kus A, Gurkan Y, Gormus SK, Solak M, Toker K. Usefulness of perfusion index to detect the effect of brachial plexus block. J Clin Monit Comput. 2013 Jun;27(3):325-8. doi: 10.1007/s10877-013-9439-4. Epub 2013 Feb 10.

  PMID: 23397432 BACKGROUND

• Ledowski T. Objective monitoring of nociception: a review of current commercial solutions. Br J Anaesth. 2019 Aug;123(2):e312-e321. doi: 10.1016/j.bja.2019.03.024. Epub 2019 Apr 30.

  PMID: 31047645 BACKGROUND

• Constant I, Sabourdin N. Monitoring depth of anesthesia: from consciousness to nociception. A window on subcortical brain activity. Paediatr Anaesth. 2015 Jan;25(1):73-82. doi: 10.1111/pan.12586. Epub 2014 Nov 20.

  PMID: 25410376 BACKGROUND

• Guo J, Zhu W, Shi Q, Bao F, Xu J. Effect of surgical pleth index-guided analgesia versus conventional analgesia techniques on fentanyl consumption under multimodal analgesia in laparoscopic cholecystectomy: a prospective, randomized and controlled study. BMC Anesthesiol. 2021 Jun 4;21(1):167. doi: 10.1186/s12871-021-01366-x.

  PMID: 34088270 BACKGROUND

• Ledowski T, Schneider M, Gruenewald M, Goyal RK, Teo SR, Hruby J. Surgical pleth index: prospective validation of the score to predict moderate-to-severe postoperative pain. Br J Anaesth. 2019 Aug;123(2):e328-e332. doi: 10.1016/j.bja.2018.10.066. Epub 2019 Mar 12.

  PMID: 30916030 BACKGROUND

Study Officials

• Safaa G Ragab, MD

  Faculty of medicine, Fayoum university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed M Abdelrayif, M.Sc.

CONTACT

01097804630; ama102@fayoum.edu.eg

Yasser S Mostafa, MD

CONTACT

01010509735; Ysm03@fayoum.edu.eg

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 14, 2026
• Study Start: July 6, 2026
• Primary Completion (Estimated): July 6, 2027
• Study Completion (Estimated): July 6, 2027
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)