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

Yilin Zhao

Status and phase: Invitation-only; Phase 4

Conditions: Pediatric ALL

Treatments: Drug: Medium-dose of ropivacaine; Drug: Low-dose ropivacaine; Drug: High-dose ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT06711679

2024S006

Details and patient eligibility

About

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

Full 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

Enrollment: 180 estimated patients

Sex: All

Ages: 1 day to 7 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 4 patient groups

Neonatal group

Experimental group

Description:

From birth to 28 days

Treatment:

Drug: High-dose ropivacaine

Drug: Medium-dose of ropivacaine

Drug: Low-dose ropivacaine

Infant group

Experimental group

Description:

1 month to 1 year

Treatment:

Drug: High-dose ropivacaine

Drug: Medium-dose of ropivacaine

Drug: Low-dose ropivacaine

Toddler Group

Experimental group

Description:

1-3 years

Treatment:

Drug: High-dose ropivacaine

Drug: Medium-dose of ropivacaine

Drug: Low-dose ropivacaine

Child Group

Experimental group

Description:

3-7 years

Treatment:

Drug: High-dose ropivacaine

Drug: Medium-dose of ropivacaine

Drug: Low-dose ropivacaine