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Exploring the Optimal Concentration of Lidocaine Test Dose for Labor Analgesia

NCT06819579 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2025-03-10
Last updated
2025-06-02

Condition(s) studied

Labor Pain

Investigational drug(s) / intervention(s)

1.5% Lidocaine →1.0% Lidocaine →0.5% Lidocaine →

1.5% Lidocaine: After successful epidural puncture, 3ml of 1.5% lidocaine was injected as a test dose

1.0% Lidocaine: After successful epidural puncture, 5ml of 1% lidocaine was injected as a test dose

0.5% Lidocaine: After successful epidural puncture, 10ml of 0.5% lidocaine was injected as a test dose

Study summary

This study aims to compare the analgesia effects and side effects of different concentrations of test dose lidocaine (1.5% lidocaine 3 ml, 1.0% lidocaine 5 ml, 0.5% lidocaine 10 ml) in labor analgesia, so as to provide a scientific basis for the clinic al practice of labor analgesia.

Eligibility

Sex
FEMALE
Min age
20 Years
Max age
40 Years
Healthy volunteers
No
Inclusion Criteria: 1. Singleton primipara 2. Aged 20-40 years 3. Pre-assessed as eligible for vaginal delivery 4. Height between 155-170 cm, BMI between 18.5-35 kg/m² 5. Cervical dilation between 2-6 cm 6. No significant history of cardiopulmonary disease 7. No history of surgical trauma 8. American Society of Anesthesiologists (ASA) Grades I-III 9. Patients are willing to participate and be able to understand and sign an informed consent form Exclusion Criteria: 1. Contraindications for spinal anesthesia, such as coagulopathy or ongoing anticoagulant therapy, infection at the puncture site, bacteremia, epidural abscess, increased intracranial pressure, severe hypovolemia 2. Physical or mental disabilities, such as scoliosis and depression, alcohol or drug abuse 3. Major organ diseases, such as hyperthyroidism, cardiopulmonary diseases, diabetes treated with insulin, and neuromuscular diseases 4. Numerical Pain Rating Scale (NPRS) \< 5 5. Refusal to participate in the study

Primary outcome measure(s)

  • The incidence of motor block — 3,5,7,9,11,13,15,20,25,30 minutes after lidocaine administration
    Bromage Scores were used to grade movement block: I free movement of legs and feet, II free movement of feet with only bent knees, III free movement of feet without bending knees, IV no movement of legs and feet, with scores of II, III and IV considered as movement block.

Trial sites (1)

FacilityCityRegionStatus
The Second Affiliated Hospital of Chongqing Medical University Chongqing Chongqing Municipality

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06819579 on ClinicalTrials.gov ↗ ← All trials in China