Clinical trial NCT06981780: Change in Femoral Artery Doppler to Predict Successful Caudal Block
Official title: Accuracy of the Change in Femoral Artery Doppler Indices as Novel Predictors to Successful Caudal Block in Pediatric Patients a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Caudal Block
Keywords: Femoral artery Doppler
Pulsatility index
Caudal block
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients undergoing abdominal or lower limb surgery under general anesthesia combined with caudal block

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

Detailed description: after institutional research ethics committee approval and obtaining informed consent from each participant. an experienced operator will examine the femoral artery using pulsed wave Doppler at baseline and 15 and 30 minutes after caudal block adminestration

Eligibility criteria: Inclusion Criteria:

* ASA1 or 2 lower abdominal or lower limb surgery

Exclusion Criteria:

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

Primary outcomes:
measure: Accuracy of Change in pulsatility index (PI) to predict successful caudal block
timeFrame: baseline and 15 minutes after the block
Secondary outcomes:
measure: Accuracy of the change in resistive index to successful caudal block
timeFrame: baseline and 15 minutes
measure: accuracy of change in waveform morphology to predict successful caudal block
timeFrame: baseline and 15 minutes after the block
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
state: Giza Governorate
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.