Peripheral Perfusion Index As an Early Predictor of Successful Caudal Block in Pediatric Patients Undergoing Lower Abdominopelvic Surgeries Under General Anesthesia

February 21, 2025 updated by: Ain Shams University
The aim of this study is to assess early predictability of peripheral perfusion index to success of caudal block in pediatric patients undergoing lower abdominopelvic surgeries

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to assess early predictability of peripheral perfusion index to success of caudal block in pediatric patients undergoing lower abdominopelvic surgeries. Preoperative assessment will be done which includes full history taking, clinical examination, standard laboratory investigations. Demographic data (age, weight, and sex) will be recorded.

All patients will be instructed to fast for 6 hours preoperatively while allowing clear fluids up to 2 hours prior to anesthesia as per the standard nil per oral (NPO) guidelines.

In the operating room, all patients will be monitored during the operation using: electrocardiography (ECG), pulse oximeter (SpO2), automated non-invasive arterial pressure (NIAP) measurement cuff, end tidal carbon dioxide (capnogram), volatile anesthetic monitoring, core temperature monitoring using a nasopharyngeal probe, and Masimo pulse oximeter probe for measuring PPI which will be applied to the big toe of the patient's foot and wrapped with gauze to reduce heat loss and to avoid the interference of ambient light.

Normothermia will be maintained using warm intravenous fluids and a forced air warm blanket.

Induction of general anesthesia will be done using inhalational sevoflurane at 8%, and after loss of consciousness, a peripheral intravenous access will be placed under complete aseptic condition. Fentanyl citrate at 1 µg/kg will be slowly injected intravenously then laryngeal mask with appropriate size will be inserted.

Maintenance of anesthesia will be with 50% oxygen-air mixture, and sevoflurane titrated to a minimum alveolar concentration MAC of 2%. Ringer acetate will be administered as the intraoperative maintenance fluid at the rate of 6 mL/kg/h.

The baseline value of PPI, heart rate (HR), and mean arterial pressure (MAP) will be recorded, corresponding to the value at 0 minute (T0) measured after induction of general anesthesia and before caudal block in supine position. The caudal block will be performed under complete aseptic conditions with the patient in the left lateral decubitus position with the hips and knees flexed using the landmark technique. Sterilization by Povidone Iodine will take place and insertion of the cannula will begin till appreciating the loss of resistance at which the needle is will be held and the cannula is advanced. After negative aspiration for blood and cerebrospinal fluid, 1mL/kg of 0.25% of bupivacaine hydrochloride will be injected at the rate of 1mL/3s and the patient will be turned supine immediately and surgical skin incision will be allowed to start 10 minutes after.

Following the caudal block, PPI, HR, and MAP will be recorded at 2, 5, 7, 10 (at skin incision), 15, and 20 minutes. Successful caudal block will be predicted as any or both of the following criteria achieved, whichever occurred earlier:

  • ≥100% increase of PPI value from baseline.
  • No tachycardia or hypertension on surgical stimulation (HR or MAP increase > 20% of baseline).

Percentage of successful blocks predicted with these criteria will be plotted against postoperative pain score as a main determinant of caudal block success with successful block defined as the following:

• Postoperative pain score as assessed by Children and Infants' Postoperative Pain Scale (CHIPPS) at 0 h and 30 min postoperatively is <4 out of 10.

A failed caudal block is defined based on failure to achieve the aforementioned criteria. And in case of block failure, an intravenous bolus of 1-2 ug/kg fentanyl will be administered intraoperatively, and a rescue post-operative analgesia in the form of bolus intravenous nalbuphine at a dose of 0.2 mg/kg will be provided to patients accordingly.

Patients will be divided into two groups based on success of the block: group (S) caudal success group, and group (F) caudal failure group. Both groups will receive the standard management (caudal block under general anesthesia) for the required procedure. There will not be a control group for this study.

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Yassmin Hassan Abdelsattar Abdelbary, M.B.B.CH., MD.
  • Phone Number: +2001095140964

Study Locations

  • Egypt
    • Abbasia
      • Cairo, Abbasia, Egypt, 11566
        • Recruiting
        • Ain Shams University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All pediatric patients undergoing elective lower abdominopelvic surgeries under general anesthesia at El-Demerdash Pediatric Surgery Hospital during the study period. Surgeries include inguinal / inguinoscrotal hernia repair, hydrocelectomy, orchiopexy.

Description

Inclusion Criteria:

  • Pediatric patients aging between 1-5 years of both sexes.
  • Pediatric patients posted for elective lower abdominopelvic surgeries under general anesthesia (duration of surgery under 120 minutes).
  • ASA physical status classes I - II.

Exclusion Criteria:

  • Guardian's refusal of procedure or participation in the study.
  • ASA classes III or above.
  • Infection at site of injection.
  • Neurological diseases and disorders such as (neuromuscular disease, cerebral palsy, spinal dysraphism …etc.)
  • Coagulopathy and bleeding disorders.
  • Hypersensitivity to the study medications.
  • Patients receiving vasoactive drugs or beta blockers.
  • Patients undergoing emergency surgery.
  • Patients in active clinical sepsis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
peripheral perfusion index predictability
Time Frame: From enrollment to discharge from post anesthesia care unit
Monitor and compare peripheral perfusion index values before and after administration of the caudal block to determine if there is a significant correlation between early PPI changes and the success of caudal block
From enrollment to discharge from post anesthesia care unit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Chair: Omar Mohamed Taha Abdallah El-Safty, M.B.B.CH., MD., Faculty of Medicine, Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

February 21, 2025

First Submitted That Met QC Criteria

February 21, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 21, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FMASU MD325/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

individual participant data might not provide further insight to research work. yet, if found helpful to further studies planned IPD sharing will be considered

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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