NCT06695520

Brief Summary

A caudal epidural block is among the most widely administered techniques of regional anesthesia in pediatric patients. It helps in reducing the intraoperative dose of inhalational anesthetic agent used for maintenance of anesthesia and in addition provides an excellent postoperative analgesia without the side effects of intravenous opioid medication, like nausea and vomiting during emergence, cardiovascular, and respiratory depression. the aim of the study was to assess, perfusion index (PI) as an indicator for success of caudal block onset in pediatric patients scheduled for elective surgery of lower abdomen, pelvic region, genital region, or lower limbs. with guidance of ultrasonography.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 19, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

November 19, 2024

Status Verified

November 1, 2024

Enrollment Period

1.2 years

First QC Date

November 17, 2024

Last Update Submit

November 17, 2024

Conditions

Caudal Epidural Block

Keywords

Perfusion Index

Outcome Measures

Primary Outcomes (1)

  • changes in perfusion index.

    measures the ratio of arterial blood flow (pulsatile flow) to venous, capillary, and tissue blood flow (non-pulsatile blood flow) and it is shown in percentage or absolute value

    baseline

Study Arms (2)

Group (A)

EXPERIMENTAL

patients will receive General Anesthesia and Caudal Epidural Anesthesia

Procedure: Caudal epidural block

GROUP (B)

NO INTERVENTION

patients will receive General Anesthesia only

Interventions

Caudal epidural blockPROCEDURE

Ultrasound Guidance: Using ultrasound improves the accuracy of the block by allowing real-time visualization of the anatomy and needle placement . injection: .5-1mg/kg of 25% bupivacaine according to the needed block level.

Group (A)

Eligibility Criteria

Age2 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ASA physical status I-II. -Both sexes -Age between 2 and 10 years -Patients scheduled for elective surgery of lower abdomen, pelvic region, genital region, or lower limbs.

You may not qualify if:

  • ASA physical status more than II.
  • Patients having any neurological disorders, bleeding disorder, bony deformity of vertebral column.
  • infection at the injection site, drug allergy, and undergoing anal surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Buono RD, Pascarella G, Costa F, Agro FE. The perfusion index could early predict a nerve block success: A preliminary report. Saudi J Anaesth. 2020 Oct-Dec;14(4):442-445. doi: 10.4103/sja.SJA_171_20. Epub 2020 Sep 24.

    PMID: 33447184BACKGROUND

  • Kao SC, Lin CS. Caudal Epidural Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:9217145. doi: 10.1155/2017/9217145. Epub 2017 Feb 26.

    PMID: 28337460BACKGROUND

  • Dave NM, Garasia M. A comparison of the effectiveness of predictors of caudal block in children-swoosh test, anal sphincter tone, and heart rate response. J Anaesthesiol Clin Pharmacol. 2012 Jan;28(1):17-20. doi: 10.4103/0970-9185.92428.

    PMID: 22345939BACKGROUND

  • Xu Z, Zhang J, Shen H, Zheng J. Assessment of pulse oximeter perfusion index in pediatric caudal block under basal ketamine anesthesia. ScientificWorldJournal. 2013 Sep 19;2013:183493. doi: 10.1155/2013/183493. eCollection 2013.

    PMID: 24174910BACKGROUND

Central Study Contacts

Monika Samir Melad Seha, resident doctor

CONTACT

+2 01111782409Monica.16285820@med.aun.edu.eg

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor at Anathesia , ICU & Pain Management

Study Record Dates

First Submitted

November 17, 2024

First Posted

November 19, 2024

Study Start

December 1, 2024

Primary Completion

February 1, 2026

Study Completion

March 1, 2026

Last Updated

November 19, 2024

Record last verified: 2024-11