NCT06981780

Brief Summary

The ideal method to predict successful caudal block is still lacking. We hypothesized that the change in femoral artery Doppler indices could accurately predict successful caudal block

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

May 13, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

May 20, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 21, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 21, 2025

Completed
Last Updated

August 27, 2025

Status Verified

August 1, 2025

Enrollment Period

3 months

First QC Date

May 13, 2025

Last Update Submit

August 21, 2025

Conditions

Keywords

Femoral artery DopplerPulsatility indexCaudal block

Outcome Measures

Primary Outcomes (1)

  • Accuracy of Change in pulsatility index (PI) to predict successful caudal block

    The change in PI measured at baseline and 15 minutes after the block

    baseline and 15 minutes after the block

Secondary Outcomes (2)

  • Accuracy of the change in resistive index to successful caudal block

    baseline and 15 minutes

  • accuracy of change in waveform morphology to predict successful caudal block

    baseline and 15 minutes after the block

Study Arms (1)

Femoral artery Doppler

Each patient will be examined using femoral artery Doppler at 3 timepoints

Device: Femoral artery Doppler

Interventions

An experienced operator will conduct femoral artery examination for the change in Doppler indices namely pulsatility index, resisitive index, and waveform morphology

Femoral artery Doppler

Eligibility Criteria

Age2 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patients undergoing abdominal or lower limb surgery under general anesthesia combined with caudal block

You may qualify if:

  • ASA1 or 2 lower abdominal or lower limb surgery

You may not qualify if:

  • allergy to bupivacaine parental refusal coagulopathy inability to obtain adequate femoral artery views

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Giza Governorate, 6890, Egypt

Location

Related Publications (5)

  • 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
  • Adolf Helmy M, Mansour M, Magdy Milad L, Mohammed Aboelregal E, Magdy Youssef M. Change in femoral artery pulsatility index as a novel predictor of post-spinal anesthesia hypotension in adult patients undergoing infra-umbilical surgeries: A prospective observational study. Anaesth Crit Care Pain Med. 2025 Apr;44(2):101482. doi: 10.1016/j.accpm.2025.101482. Epub 2025 Jan 21. No abstract available.

    PMID: 39848332BACKGROUND
  • Kim ES, Sharma AM, Scissons R, Dawson D, Eberhardt RT, Gerhard-Herman M, Hughes JP, Knight S, Marie Kupinski A, Mahe G, Neumyer M, Poe P, Shugart R, Wennberg P, Williams DM, Zierler RE. Interpretation of peripheral arterial and venous Doppler waveforms: A consensus statement from the Society for Vascular Medicine and Society for Vascular Ultrasound. Vasc Med. 2020 Oct;25(5):484-506. doi: 10.1177/1358863X20937665. Epub 2020 Jul 15.

    PMID: 32667274BACKGROUND
  • Boretsky KR, Camelo C, Waisel DB, Falciola V, Sullivan C, Brusseau E, Eastburn E, Gomez-Moraz A, Luckanavanich W. Confirmation of success rate of landmark-based caudal blockade in children using ultrasound: A prospective analysis. Paediatr Anaesth. 2020 Jun;30(6):671-675. doi: 10.1111/pan.13865.

    PMID: 32267040BACKGROUND
  • 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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anesthesia and critical care

Study Record Dates

First Submitted

May 13, 2025

First Posted

May 21, 2025

Study Start

May 20, 2025

Primary Completion

August 20, 2025

Study Completion

August 21, 2025

Last Updated

August 27, 2025

Record last verified: 2025-08

Locations