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

NCT06711679 | Enrolling By Invitation Phase 4 DMC

• 1 other identifier: 2024S006
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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

Conditions

Pediatric ALL

Keywords

Caudal anesthesia; Children; Thermal imaging; Intraoperative MRI

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

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

  60 minutes

• Effects of different volumes and concentrations of ropivacaine on heart rate

  2 days

• Effects of different volumes and concentrations of ropivacaine on blood pressure

  2 days

• Effects of different volumes and concentrations of ropivacaine on oxygenation

  2 days

• To evaluate the relaxation degree of anal sphincter after sacral anesthesia

  30 minutes

Study Arms (4)

Neonatal group

EXPERIMENTAL

From birth to 28 days

Drug: Low-dose ropivacaine; Drug: Medium-dose of ropivacaine; Drug: High-dose ropivacaine

Infant group

EXPERIMENTAL

1 month to 1 year

Drug: Low-dose ropivacaine; Drug: Medium-dose of ropivacaine; Drug: High-dose ropivacaine

Toddler Group

EXPERIMENTAL

1-3 years

Drug: Low-dose ropivacaine; Drug: Medium-dose of ropivacaine; Drug: High-dose ropivacaine

Child Group

EXPERIMENTAL

3-7 years

Drug: Low-dose ropivacaine; Drug: Medium-dose of ropivacaine; Drug: High-dose ropivacaine

Interventions

Low-dose ropivacaine DRUG

0.5 ml/Kg ropivacaine

Also known as: MRI scan

Child Group; Infant group; Neonatal group; Toddler Group

Medium-dose of ropivacaine DRUG

1ml/Kg ropivacaine

Also known as: MRI scan

Child Group; Infant group; Neonatal group; Toddler Group

High-dose ropivacaine DRUG

1.5 ml/Kg ropivacaine

Also known as: MRI scan

Child Group; Infant group; Neonatal group; Toddler Group

Eligibility Criteria

• Age: 1 Day - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Abnormal coagulation function; Allergy to local anesthetics; Abnormal sacral anatomy; Puncture site infection;

Sponsors & Collaborators

• Yilin Zhao: lead
• Henan Provincial People's Hospital: collaborator
• Wuhan Children's Hospital: collaborator

Study Sites (1)

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

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Ropivacaine; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Yilin Zhao, M.D, Ph.D

  Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: December 2, 2024
• Study Start: May 10, 2024
• Primary Completion: December 20, 2024
• Study Completion: March 20, 2026
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)