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

Phase 4

• Conditions: Pediatric ALL
• Interventions: Drug: Low-dose ropivacaine; Drug: Medium-dose of ropivacaine; Drug: High-dose ropivacaine

• Registration Number: NCT06711679
• Lead Sponsor: Yilin Zhao

Brief 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

* 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 Timeline

• Study Start: 2024-05-10
• Status Verified: 2024-11
• Study First Submitted: 2024-11-19
• Study First Submitted QC: 2024-11-26
• Last Update Submitted: 2024-11-26
• Study First Posted: 2024-12-02
• Last Update Posted: 2024-12-02
• Primary Completion: 2024-12-20
• Study Completion: 2026-03-20

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 180

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Child Group	High-dose ropivacaine	3-7 years
Infant group	Low-dose ropivacaine	1 month to 1 year
Infant group	Medium-dose of ropivacaine	1 month to 1 year
Infant group	High-dose ropivacaine	1 month to 1 year
Toddler Group	Low-dose ropivacaine	1-3 years
Toddler Group	Medium-dose of ropivacaine	1-3 years
Toddler Group	High-dose ropivacaine	1-3 years
Child Group	Low-dose ropivacaine	3-7 years
Child Group	Medium-dose of ropivacaine	3-7 years
Neonatal group	Low-dose ropivacaine	From birth to 28 days
Neonatal group	Medium-dose of ropivacaine	From birth to 28 days
Neonatal group	High-dose ropivacaine	From birth to 28 days

Primary Outcome Measures

Name	Time	Method
Distribution and block plane in the spinal canal after caudal injection of different doses of ropivacaine.	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	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	2 days	The fixed capacity requires the minimum effective concentration by changing the concentration

Secondary Outcome Measures

Name	Time	Method
Effects ofMedium-dose and high-dose of ropivacaine injection on Optic Nerve Sheath Diameter (ONSD) and blood brain barrier	60 minutes	Optic Nerve Sheath Diameter (ONSD) and blood brain barrier will be meseared before and after injection, and after sugery operation
Effects of different volumes and concentrations of ropivacaine on heart rate	2 days	Effects on heart rate after different volumes and concentrations of ropivacaine injection
Effects of different volumes and concentrations of ropivacaine on blood pressure	2 days	Effects on blood pressure after different volumes and concentrations of ropivacaine injection
Effects of different volumes and concentrations of ropivacaine on oxygenation	2 days	Effects on oxygenation after different volumes and concentrations of ropivacaine injection
To evaluate the relaxation degree of anal sphincter after sacral anesthesia	30 minutes	Measure the pressure changes of the anal sphincter after caudal anesthesia using a pressure sensor

Trial Locations

Locations (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China