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NCT Number: NCT06711679

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

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

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Key information

Age range

1 day–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Wuhan, Hubei, 430030, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Low-dose ropivacaine

Drug

0.5 ml/Kg ropivacaine

Other names: MRI scan

Medium-dose of ropivacaine

Drug

1ml/Kg ropivacaine

Other names: MRI scan

High-dose ropivacaine

Drug

1.5 ml/Kg ropivacaine

Other names: MRI scan

Primary outcomes

  1. Distribution and block plane in the spinal canal after caudal injection of different doses of ropivacaine.

    Time frame: 30 minutes

    MRI scan will be performed before and after 0.5 ml/Kg, 1,ml/Kg, or 1.5ml/Kg ropivacaine injection,

  2. The blockade level after caudal anesthesia with varying doses

    Time frame: 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.

  3. The minimum effective concentration of ropivacaine among pediatric patients of different age groups

    Time frame: 2 days

    The fixed capacity requires the minimum effective concentration by changing the concentration

Secondary outcomes

  1. Effects ofMedium-dose and high-dose of ropivacaine injection on Optic Nerve Sheath Diameter (ONSD) and blood brain barrier

    Time frame: 60 minutes

    Optic Nerve Sheath Diameter (ONSD) and blood brain barrier will be meseared before and after injection, and after sugery operation

  2. Effects of different volumes and concentrations of ropivacaine on heart rate

    Time frame: 2 days

    Effects on heart rate after different volumes and concentrations of ropivacaine injection

  3. Effects of different volumes and concentrations of ropivacaine on blood pressure

    Time frame: 2 days

    Effects on blood pressure after different volumes and concentrations of ropivacaine injection

  4. Effects of different volumes and concentrations of ropivacaine on oxygenation

    Time frame: 2 days

    Effects on oxygenation after different volumes and concentrations of ropivacaine injection

  5. To evaluate the relaxation degree of anal sphincter after sacral anesthesia

    Time frame: 30 minutes

    Measure the pressure changes of the anal sphincter after caudal anesthesia using a pressure sensor

Sponsors and collaborators

Lead sponsor

YiLin Zhao

Other

Collaborators

  • Henan Provincial People's Hospital
  • Wuhan Children's Hospital

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2026
First posted
Dec 2, 2024
Registry last updated
Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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