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

NCT06711679 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2024-12-02

No results posted yet for this study

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

Conditions

  • Pediatric ALL

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

Sponsors & Collaborators

  • Henan Provincial People's Hospital

    collaborator OTHER
  • Wuhan Children's Hospital

    collaborator OTHER
  • Yilin Zhao

    lead OTHER

Principal Investigators

  • Yilin Zhao, M.D, Ph.D · Huazhong University of Science and Technology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-10
Primary Completion
2024-12-20
Completion
2026-03-20

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06711679 on ClinicalTrials.gov