Pediatric ALLPhase 4NCT06711679
Exploring the Minimum Effective Concentration and Volume of Ropivacaine for Sacral Plexus Anesthesia
A Phase 4 study testing Low-dose ropivacaine, Medium-dose of ropivacaine and High-dose ropivacaine in people with Pediatric ALL, run by Yilin Zhao at 1 site in China.
Trial summary
The goal of this clinical trial is to explore the minimum effective concentration and volume of ropivacaine for sacral plexus anesthesia. The main questions it aims to answer are: The distribution of different volumes of ropivacaine after caudal anesthesia The blockade level after caudal anesthesia with varying doses… Read more about this study
- Who is it for?
- Ages 1 day to 7 years
- Conditions the study is for
- Pediatric ALL
- What is being tested?
- Low-dose ropivacaine, Medium-dose of ropivacaine and High-dose ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2024to 20 Mar 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 1 day to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- BMI ≤ 30 kg/m²; lower limbs surgery; lower abdomen surgery; perineal region surgery; Normal liver and kidney function; Normal coagulation function; Hemoglobin > 70 g/L.
Who cannot join
- Abnormal coagulation function; Allergy to local anesthetics; Abnormal sacral anatomy; Puncture site infection;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: Exploring the Minimum Effective Concentration and Volume of Ropivacaine for Sacral Plexus Anesthesia in Children of Different Ages
The goal of this clinical trial is to explore the minimum effective concentration and volume of ropivacaine for sacral plexus anesthesia. The main questions it aims to answer are:
- The distribution of different volumes of ropivacaine after caudal anesthesia
- The blockade level after caudal anesthesia with varying doses
- The minimum effective concentration of ropivacaine among pediatric patients of different age groups Researchers will inject different doses or concentrations of ropivacaine into the caudal canal to observe the drug's spread range, the level of blockade, and the duration of its effect.
Read more
Participants will:
- Undergo magnetic resonance imaging (MRI) examinations before and after caudal anesthesia
- Will be detected the blockade level after caudal anesthesia
Read the detailed description
The activity of CYP1A2 in newborns and infants is lower than in adults, which may result in slower metabolism of ropivacaine. This might necessitate a reduction in the dosage or concentration of ropivacaine to prevent drug accumulation and toxicity. Additionally, since the nervous system in children is still developing, excessively high concentrations of ropivacaine could have adverse effects. Therefore, the lowest effective concentration of ropivacaine should be chosen to minimize the risk of adverse reactions. Generally, the dosage of ropivacaine should be determined based on the patient's age, weight, and the type of surgery. However, there are currently no definitive dosage recommendations, and further research is needed to determine these guidelines.
The goal of this clinical trial is to exploring the minimum effective concentration and volume of ropivacaine for sacral plexus anesthesia. Using MRI to investigate the distribution of different doses of ropivacaine after caudal anesthesia, and employing infrared imaging technology to detect the blockade level after caudal anesthesia with varying doses.
Participants will receive 0.5ml/Kg, 1ml/Kg and 1.5ml/Kg ropivacaine, then undergo magnetic resonance imaging (MRI) examinations to detect the distribution and optic nerve sheath diameter (ONSD) before and after caudal injection. Also, the blockade level will be detected 15min and 30 min after caudal anesthesia
- Conditions
- Pediatric ALL
- Being tested
- Low-dose ropivacaine, Medium-dose of ropivacaine, High-dose ropivacaine
- Keywords
- Caudal anesthesia, Children, Thermal imaging, Intraoperative MRI
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose ropivacaineDrug
Also called MRI scan
0.5 ml/Kg ropivacaine
Medium-dose of ropivacaineDrug
Also called MRI scan
1ml/Kg ropivacaine
High-dose ropivacaineDrug
Also called MRI scan
1.5 ml/Kg ropivacaine
| Study group | Role | What they receive |
|---|---|---|
| Neonatal group | Experimental | From birth to 28 days Receives: Drug: Low-dose ropivacaine; Drug: Medium-dose of ropivacaine; Drug: High-dose ropivacaine |
| Infant group | Experimental | 1 month to 1 year Receives: Drug: Low-dose ropivacaine; Drug: Medium-dose of ropivacaine; Drug: High-dose ropivacaine |
| Toddler Group | Experimental | 1-3 years Receives: Drug: Low-dose ropivacaine; Drug: Medium-dose of ropivacaine; Drug: High-dose ropivacaine |
| Child Group | Experimental | 3-7 years Receives: Drug: Low-dose ropivacaine; Drug: Medium-dose of ropivacaine; Drug: High-dose ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution and block plane in the spinal canal after caudal injection of different doses of ropivacaine.
MRI scan will be performed before and after 0.5 ml/Kg, 1,ml/Kg, or 1.5ml/Kg ropivacaine injection,
Measured: 30 minutes
The blockade level after caudal anesthesia with varying doses
The blockade level will be tested 15 min and 30min after 0.5 ml/Kg, 1,ml/Kg, or 1.5ml/Kg ropivacaine injection. The infrared imaging technology will be employed to test the blockade level.
Measured: 60 minutes
The minimum effective concentration of ropivacaine among pediatric patients of different age groups
The fixed capacity requires the minimum effective concentration by changing the concentration
Measured: 2 days
Secondary outcomes (5)
Effects ofMedium-dose and high-dose of ropivacaine injection on Optic Nerve Sheath Diameter (ONSD) and blood brain barrier
Optic Nerve Sheath Diameter (ONSD) and blood brain barrier will be meseared before and after injection, and after sugery operation
Measured: 60 minutes
Effects of different volumes and concentrations of ropivacaine on heart rate
Effects on heart rate after different volumes and concentrations of ropivacaine injection
Measured: 2 days
Effects of different volumes and concentrations of ropivacaine on blood pressure
Effects on blood pressure after different volumes and concentrations of ropivacaine injection
Measured: 2 days
Effects of different volumes and concentrations of ropivacaine on oxygenation
Effects on oxygenation after different volumes and concentrations of ropivacaine injection
Measured: 2 days
To evaluate the relaxation degree of anal sphincter after sacral anesthesia
Measure the pressure changes of the anal sphincter after caudal anesthesia using a pressure sensor
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start10 May 2024
- Primary completion20 Dec 2024 (estimated)
- Study completion20 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ALLStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yilin Zhao
- Sponsor type
- University, hospital or other
- Collaborators
- Henan Provincial People's Hospital, Wuhan Children's Hospital
- Responsible party
- Sponsor-investigator, Yilin Zhao, Tongji Hospital
- Investigators
- Yilin Zhao, M.D, Ph.D, Principal investigator, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06711679
- Sponsor's protocol ID
- 2024S006
- Status last verified
- Nov 2024
- First submitted
- 19 Nov 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Minimum Effective Concentration and Volume of Ropivacaine for Sacral Plexus Anesthesia in Children of Different Ages
- ClinicalTrials.gov ID
- NCT06711679
- Acronym / sponsor ID
- 2024S006
- Conditions
- Pediatric ALL
- Keywords
- Caudal anesthesia, Children, Thermal imaging, Intraoperative MRI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Yilin ZhaoUniversity, hospital or other
- Collaborators
- Henan Provincial People's Hospital, Wuhan Children's Hospital
- Study start
- 10 May 2024 (actual)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 20 Mar 2026 (estimated)
- First posted
- 2 Dec 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 this clinical trial is to explore the minimum effective concentration and volume of ropivacaine for sacral plexus anesthesia. The main questions it aims to answer are:
- The distribution of different volumes of ropivacaine after caudal anesthesia
- The blockade level after caudal anesthesia with varying doses
- The minimum effective concentration of ropivacaine among pediatric patients of different age groups Researchers will inject different doses or concentrations of ropivacaine into the caudal canal to observe the drug's spread range, the level of blockade, and the duration of its effect.
Participants will:
- Undergo magnetic resonance imaging (MRI) examinations before and after caudal anesthesia
- Will be detected the blockade level after caudal anesthesia
Detailed description
The activity of CYP1A2 in newborns and infants is lower than in adults, which may result in slower metabolism of ropivacaine. This might necessitate a reduction in the dosage or concentration of ropivacaine to prevent drug accumulation and toxicity. Additionally, since the nervous system in children is still developing, excessively high concentrations of ropivacaine could have adverse effects. Therefore, the lowest effective concentration of ropivacaine should be chosen to minimize the risk of adverse reactions. Generally, the dosage of ropivacaine should be determined based on the patient's age, weight, and the type of surgery. However, there are currently no definitive dosage recommendations, and further research is needed to determine these guidelines.
The goal of this clinical trial is to exploring the minimum effective concentration and volume of ropivacaine for sacral plexus anesthesia. Using MRI to investigate the distribution of different doses of ropivacaine after caudal anesthesia, and employing infrared imaging technology to detect the blockade level after caudal anesthesia with varying doses.
Participants will receive 0.5ml/Kg, 1ml/Kg and 1.5ml/Kg ropivacaine, then undergo magnetic resonance imaging (MRI) examinations to detect the distribution and optic nerve sheath diameter (ONSD) before and after caudal injection. Also, the blockade level will be detected 15min and 30 min after caudal anesthesia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Neonatal group | Experimental | Drug: Low-dose ropivacaine, Drug: Medium-dose of ropivacaine, Drug: High-dose ropivacaineFrom birth to 28 days |
| Infant group | Experimental | Drug: Low-dose ropivacaine, Drug: Medium-dose of ropivacaine, Drug: High-dose ropivacaine1 month to 1 year |
| Toddler Group | Experimental | Drug: Low-dose ropivacaine, Drug: Medium-dose of ropivacaine, Drug: High-dose ropivacaine1-3 years |
| Child Group | Experimental | Drug: Low-dose ropivacaine, Drug: Medium-dose of ropivacaine, Drug: High-dose ropivacaine3-7 years |
Who may qualify
- Ages
- 1 day to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- BMI ≤ 30 kg/m²; lower limbs surgery; lower abdomen surgery; perineal region surgery; Normal liver and kidney function; Normal coagulation function; Hemoglobin > 70 g/L.
Key exclusion criteria (1 listed)
- Abnormal coagulation function; Allergy to local anesthetics; Abnormal sacral anatomy; Puncture site infection;
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 |
|---|---|---|
| Low-dose ropivacaineAlso: MRI scan0.5 ml/Kg ropivacaine | Drug | Child Group, Infant group, Neonatal group, Toddler Group |
| Medium-dose of ropivacaineAlso: MRI scan1ml/Kg ropivacaine | Drug | Child Group, Infant group, Neonatal group, Toddler Group |
| High-dose ropivacaineAlso: MRI scan1.5 ml/Kg ropivacaine | Drug | Child Group, Infant group, Neonatal group, Toddler Group |
Primary outcome
Distribution and block plane in the spinal canal after caudal injection of different doses of ropivacaine.
Time frame: 30 minutes
MRI scan will be performed before and after 0.5 ml/Kg, 1,ml/Kg, or 1.5ml/Kg ropivacaine injection,
The blockade level after caudal anesthesia with varying doses
Time frame: 60 minutes
The blockade level will be tested 15 min and 30min after 0.5 ml/Kg, 1,ml/Kg, or 1.5ml/Kg ropivacaine injection. The infrared imaging technology will be employed to test the blockade level.
The minimum effective concentration of ropivacaine among pediatric patients of different age groups
Time frame: 2 days
The fixed capacity requires the minimum effective concentration by changing the concentration
5 secondary outcomes
Effects ofMedium-dose and high-dose of ropivacaine injection on Optic Nerve Sheath Diameter (ONSD) and blood brain barrier
Time frame: 60 minutes
Effects of different volumes and concentrations of ropivacaine on heart rate
Time frame: 2 days
Effects of different volumes and concentrations of ropivacaine on blood pressure
Time frame: 2 days
Effects of different volumes and concentrations of ropivacaine on oxygenation
Time frame: 2 days
To evaluate the relaxation degree of anal sphincter after sacral anesthesia
Time frame: 30 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Yilin Zhao, M.D, Ph.D principal investigator
Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Low-dose ropivacaine, Medium-dose of ropivacaine and High-dose ropivacaine in people with Pediatric ALL, run by Yilin Zhao at 1 site in China.
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: enrolling by invitation, as of the sponsor's last update on 2 Dec 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 China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Distribution and block plane in the spinal canal after caudal injection of different doses of ropivacaine. (time frame: 30 minutes). The study lists 3 primary outcomes in all. 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 2 Dec 2024.