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Exploring the Minimum Effective Concentration and Volume of Ropivacaine for Sacral Plexus Anesthesia

NCT ID: NCT06711679

Last Updated: 2024-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE4

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-10

Study Completion Date

2026-03-20

Brief Summary

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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

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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

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Pediatric ALL

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Neonatal group

From birth to 28 days

Group Type EXPERIMENTAL

Low-dose ropivacaine

Intervention Type DRUG

0.5 ml/Kg ropivacaine

Medium-dose of ropivacaine

Intervention Type DRUG

1ml/Kg ropivacaine

High-dose ropivacaine

Intervention Type DRUG

1.5 ml/Kg ropivacaine

Infant group

1 month to 1 year

Group Type EXPERIMENTAL

Low-dose ropivacaine

Intervention Type DRUG

0.5 ml/Kg ropivacaine

Medium-dose of ropivacaine

Intervention Type DRUG

1ml/Kg ropivacaine

High-dose ropivacaine

Intervention Type DRUG

1.5 ml/Kg ropivacaine

Toddler Group

1-3 years

Group Type EXPERIMENTAL

Low-dose ropivacaine

Intervention Type DRUG

0.5 ml/Kg ropivacaine

Medium-dose of ropivacaine

Intervention Type DRUG

1ml/Kg ropivacaine

High-dose ropivacaine

Intervention Type DRUG

1.5 ml/Kg ropivacaine

Child Group

3-7 years

Group Type EXPERIMENTAL

Low-dose ropivacaine

Intervention Type DRUG

0.5 ml/Kg ropivacaine

Medium-dose of ropivacaine

Intervention Type DRUG

1ml/Kg ropivacaine

High-dose ropivacaine

Intervention Type DRUG

1.5 ml/Kg ropivacaine

Interventions

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Low-dose ropivacaine

0.5 ml/Kg ropivacaine

Intervention Type DRUG

Medium-dose of ropivacaine

1ml/Kg ropivacaine

Intervention Type DRUG

High-dose ropivacaine

1.5 ml/Kg ropivacaine

Intervention Type DRUG

Other Intervention Names

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MRI scan MRI scan MRI scan

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

Abnormal coagulation function; Allergy to local anesthetics; Abnormal sacral anatomy; Puncture site infection;
Minimum Eligible Age

1 Day

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henan Provincial People's Hospital

OTHER

Sponsor Role collaborator

Wuhan Children's Hospital

OTHER

Sponsor Role collaborator

Yilin Zhao

OTHER

Sponsor Role lead

Responsible Party

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Yilin Zhao

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Yilin Zhao, M.D, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Huazhong University of Science and Technology

Locations

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Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status

Countries

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China

Other Identifiers

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2024S006

Identifier Type: -

Identifier Source: org_study_id