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

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.

Participants will:

• Undergo magnetic resonance imaging (MRI) examinations before and after caudal anesthesia
• Will be detected the blockade level after caudal anesthesia

Study Overview

• Status: Enrolling by invitation
• Conditions: Pediatric ALL
• Intervention / Treatment: Drug: Low-dose ropivacaine; Drug: Medium-dose of ropivacaine; Drug: High-dose ropivacaine

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 Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neonatal group; From birth to 28 days	Drug: Low-dose ropivacaine; 0.5 ml/Kg ropivacaine; Other Names: MRI scan; Drug: Medium-dose of ropivacaine; 1ml/Kg ropivacaine; Other Names: MRI scan; Drug: High-dose ropivacaine; 1.5 ml/Kg ropivacaine; Other Names: MRI scan
Experimental: Infant group; 1 month to 1 year	Drug: Low-dose ropivacaine; 0.5 ml/Kg ropivacaine; Other Names: MRI scan; Drug: Medium-dose of ropivacaine; 1ml/Kg ropivacaine; Other Names: MRI scan; Drug: High-dose ropivacaine; 1.5 ml/Kg ropivacaine; Other Names: MRI scan
Experimental: Toddler Group; 1-3 years	Drug: Low-dose ropivacaine; 0.5 ml/Kg ropivacaine; Other Names: MRI scan; Drug: Medium-dose of ropivacaine; 1ml/Kg ropivacaine; Other Names: MRI scan; Drug: High-dose ropivacaine; 1.5 ml/Kg ropivacaine; Other Names: MRI scan
Experimental: Child Group; 3-7 years	Drug: Low-dose ropivacaine; 0.5 ml/Kg ropivacaine; Other Names: MRI scan; Drug: Medium-dose of ropivacaine; 1ml/Kg ropivacaine; Other Names: MRI scan; Drug: High-dose ropivacaine; 1.5 ml/Kg ropivacaine; Other Names: MRI scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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,	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.	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	2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	2 days
Effects of different volumes and concentrations of ropivacaine on oxygenation	Effects on oxygenation after different volumes and concentrations of ropivacaine injection	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	30 minutes

Collaborators and Investigators

• Sponsor: YiLin Zhao
• Collaborators: Henan Provincial People's Hospital; Wuhan Children's Hospital
• Investigators: Principal Investigator: Yilin Zhao, M.D, Ph.D, Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2024
• Primary Completion (Estimated): December 20, 2024
• Study Completion (Estimated): March 20, 2026

Study Registration Dates

• First Submitted: November 19, 2024
• First Submitted That Met QC Criteria: November 26, 2024
• First Posted (Estimated): December 2, 2024

Study Record Updates

• Last Update Posted (Estimated): December 2, 2024
• Last Update Submitted That Met QC Criteria: November 26, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Children; Intraoperative MRI; Caudal anesthesia; Thermal imaging
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Ropivacaine
• Other Study ID Numbers: 2024S006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No