Menu
Enrolling by invitation NCT06711679

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

Phase IV Interventional Pediatric ALL

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Low-dose ropivacaine, Medium-dose of ropivacaine, High-dose ropivacaine.
Who it may be relevant to
Registry conditions: Pediatric ALL. Basic parameters: 1 Day — 7 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Exploring the Minimum Effective Concentration and Volume of Ropivacaine for Sacral Plexus Anesthesia in Children of Different Ages

Overview

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

Interventions

  • Drug Low-dose ropivacaine
    0.5 ml/Kg ropivacaine
  • Drug Medium-dose of ropivacaine
    1ml/Kg ropivacaine
  • Drug High-dose ropivacaine
    1.5 ml/Kg ropivacaine

Primary outcome measures

  • Distribution and block plane in the spinal canal after caudal injection of different doses of ropivacaine. [Time frame: 30 minutes]
  • The blockade level after caudal anesthesia with varying doses [Time frame: 60 minutes]
  • The minimum effective concentration of ropivacaine among pediatric patients of different age groups [Time frame: 2 days]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan

Identifiers

NCT: NCT06711679 · 2024S006

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗