Caudal BlockNCT06981780
Change in Femoral Artery Doppler to Predict Successful Caudal Block
An observational study of Caudal Block, run by Cairo University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 2 to 8 years
- Conditions the study is for
- Caudal Block
- What is being tested?
- Femoral artery Doppler
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 20 May 2025to 21 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 8 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients undergoing abdominal or lower limb surgery under general anesthesia combined with caudal block
Who may be able to join
- ASA1 or 2 lower abdominal or lower limb surgery
Who cannot join
- allergy to bupivacaine parental refusal coagulopathy inability to obtain adequate femoral artery views
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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
- Conditions
- Caudal Block
- Being tested
- Femoral artery Doppler
- Keywords
- Femoral artery Doppler, Pulsatility index, Caudal block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral artery DopplerDevice
An experienced operator will conduct femoral artery examination for the change in Doppler indices namely pulsatility index, resisitive index, and waveform morphology
| Study group | Role | What they receive |
|---|---|---|
| Femoral artery Doppler | Each patient will be examined using femoral artery Doppler at 3 timepoints Receives: Device: Femoral artery Doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline and 15 minutes after the block
Secondary outcomes (2)
Accuracy of the change in resistive index to successful caudal block
The change in RI at baseline and 15 minutes after the block
Measured: baseline and 15 minutes
accuracy of change in waveform morphology to predict successful caudal block
The change in femoral artery waveform from triphasic to a monophasic wave
Measured: baseline and 15 minutes after the block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start20 May 2025
- Primary completion20 Aug 2025
- Study completion21 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Caudal BlockStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Adolf Helmy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06981780
- Sponsor's protocol ID
- Doppler and caudal block
- Status last verified
- Aug 2025
- First submitted
- 13 May 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data regarding this study will be available from the corresponding author upon reasonable request
Publications
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.
PubMed 24174910Adolf 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.
PubMed 39848332Kim 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.
PubMed 32667274Boretsky 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.
PubMed 32267040Kao 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.
PubMed 28337460
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06981780
- Acronym / sponsor ID
- Doppler and caudal block
- Conditions
- Caudal Block
- Keywords
- Femoral artery Doppler, Pulsatility index, Caudal block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 May 2025 (actual)
- Primary completion
- 20 Aug 2025 (actual)
- Study completion
- 21 Aug 2025 (actual)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Femoral artery Doppler | – | Device: Femoral artery DopplerEach patient will be examined using femoral artery Doppler at 3 timepoints |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients undergoing abdominal or lower limb surgery under general anesthesia combined with caudal block
Key inclusion criteria (1 listed)
- ASA1 or 2 lower abdominal or lower limb surgery
Key exclusion criteria (1 listed)
- allergy to bupivacaine parental refusal coagulopathy inability to obtain adequate femoral artery views
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Femoral artery DopplerAn experienced operator will conduct femoral artery examination for the change in Doppler indices namely pulsatility index, resisitive index, and waveform morphology | Device | Femoral artery Doppler |
Primary outcome
Accuracy of Change in pulsatility index (PI) to predict successful caudal block
Time frame: baseline and 15 minutes after the block
The change in PI measured at baseline and 15 minutes after the block
2 secondary outcomes
Accuracy of the change in resistive index to successful caudal block
Time frame: baseline and 15 minutes
accuracy of change in waveform morphology to predict successful caudal block
Time frame: baseline and 15 minutes after the block
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Results publication: PubMed 24174910Xu 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.
- Results publication: PubMed 39848332Adolf 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.
- Results publication: PubMed 32667274Kim 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.
- Results publication: PubMed 32267040Boretsky 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.
- Results publication: PubMed 28337460Kao 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.
- Individual participant dataSharing planned: Undecided. Data regarding this study will be available from the corresponding author upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Caudal Block, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Change in pulsatility index (PI) to predict successful caudal block (time frame: baseline and 15 minutes after the block). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06981780, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.