Compare Ultrasound-guided Caudal Block to the Conventional Technique Based on Anatomical LandmarksNCT06655571
What Technique for Caudal Block in Children: Conventional or Ultrasound-guided
A study testing Ultrasound guided caudal Block and Conventionel in people with Compare Ultrasound-guided Caudal Block to the Conventional Technique Based on Anatomical Landmarks, run by Tunis University at 1 site in Tunisia.
Trial summary
The goal of our study is to compare ultrasound-guided caudal block to the conventional technique based on anatomical landmarks. Read more about this study
- Who is it for?
- Ages 6 months to 6 years
- Conditions the study is for
- Compare Ultrasound-guided Caudal Block to the Conventional Technique Based on Anatomical Landmarks
- What is being tested?
- Ultrasound guided caudal Block and Conventionel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Aug 2024to 31 Mar 2025
- Phase
- Interventional
- 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 6 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children aged between 6 months and 6 years, ASA 1 , underwent elective surgery
Who cannot join
- severe systemic diseases, previous neurological or spinal disorders, coagulation abnormalities, allergies toward LAs, local infection at the block site
Trial locations and contacts
1 site in 1 country.
Tunisia1 site, 1 recruiting
- Recruiting
Bechir Hamza hospital
Tunis, Tunis Governorate, 2001
salma Aouadi, 0021656652210, salmaaouadi1@gmail.com
About this study
The goal of our study is to compare ultrasound-guided caudal block to the conventional technique based on anatomical landmarks.
Read the detailed description
The primary endpoint was the success rate of each technique. We also collected the time taken for each technique, the number of punctures, and the incidence of complications (subcutaneous infiltration, intravascular injection).
Children were randomized to receive a caudal block based on anatomical landmarks (group C) or ultrasound-guided (group E) at a dose of 1 ml/kg of 0.25% bupivacaine, not exceeding 20 ml.
- Conditions
- Compare Ultrasound-guided Caudal Block to the Conventional Technique Based on Anatomical Landmarks
- Being tested
- Ultrasound guided caudal Block, Conventionel
- Keywords
- caudal block - children - ultrasound - conventional method
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided caudal BlockProcedure or surgery
caudal block using Ultrasound
ConventionelProcedure or surgery
Caudal Block based on anatomical landmarks
| Study group | Role | What they receive |
|---|---|---|
| ultrasound | Other | Caudal bloc guided by Ultrasound Receives: Procedure: Ultrasound guided caudal Block |
| Conventionel | Other | Caudal Block based on anatomical landmarks Receives: Procedure: Conventionel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of block
A successful block was defined as an absence of significant motor movements following surgical induction or aberrations in the heart or respiratory rates
Measured: during surgery
Secondary outcomes (3)
block performing time
the period between anatomical structures identification and termination of LA administration
Measured: perioperative
number of needle puncture
Measured: during procedure
complication rates
Blood aspiration Subcutaneous bulging Bone contact Dural puncture Local anesthetic toxicity
Measured: during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start1 Aug 2024
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compare Ultrasound-guided Caudal Block to the Conventional Technique Based on Anatomical LandmarksStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- caudal block based on anatomical landmarks (group C) or ultrasound-guided (group E)
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tunis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehdi Trifa, Tunis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655571
- Sponsor's protocol ID
- 172024
- Status last verified
- Oct 2024
- First submitted
- 21 Oct 2024
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Technique for Caudal Block in Children: Conventional or Ultrasound-guided
- ClinicalTrials.gov ID
- NCT06655571
- Acronym / sponsor ID
- 172024
- Conditions
- Compare Ultrasound-guided Caudal Block to the Conventional Technique Based on Anatomical Landmarks
- Keywords
- caudal block - children - ultrasound - conventional method
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Tunis UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 23 Oct 2024 (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 goal of our study is to compare ultrasound-guided caudal block to the conventional technique based on anatomical landmarks.
Detailed description
The primary endpoint was the success rate of each technique. We also collected the time taken for each technique, the number of punctures, and the incidence of complications (subcutaneous infiltration, intravascular injection).
Children were randomized to receive a caudal block based on anatomical landmarks (group C) or ultrasound-guided (group E) at a dose of 1 ml/kg of 0.25% bupivacaine, not exceeding 20 ml.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- caudal block based on anatomical landmarks (group C) or ultrasound-guided (group E)
| Arm | Type | Receives |
|---|---|---|
| ultrasound | Other | Procedure: Ultrasound guided caudal BlockCaudal bloc guided by Ultrasound |
| Conventionel | Other | Procedure: ConventionelCaudal Block based on anatomical landmarks |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children aged between 6 months and 6 years, ASA 1 , underwent elective surgery
Key exclusion criteria (1 listed)
- severe systemic diseases, previous neurological or spinal disorders, coagulation abnormalities, allergies toward LAs, local infection at the block site
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 |
|---|---|---|
| Ultrasound guided caudal Blockcaudal block using Ultrasound | Procedure or surgery | ultrasound |
| ConventionelCaudal Block based on anatomical landmarks | Procedure or surgery | Conventionel |
Primary outcome
Success rate of block
Time frame: during surgery
A successful block was defined as an absence of significant motor movements following surgical induction or aberrations in the heart or respiratory rates
3 secondary outcomes
block performing time
Time frame: perioperative
number of needle puncture
Time frame: during procedure
complication rates
Time frame: during procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided caudal Block and Conventionel in people with Compare Ultrasound-guided Caudal Block to the Conventional Technique Based on Anatomical Landmarks, run by Tunis University at 1 site in Tunisia.
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: status not confirmed, as of the sponsor's last update on 23 Oct 2024. 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 Tunisia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact salma Aouadi, Hospital university assistant (56652210, salmaaouadi1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of block (time frame: during surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2024.