Exploring the Optimal Concentration of Lidocaine Test Dose for Labor Analgesia

NCT ID: NCT06819579

Last Updated: 2025-06-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-10
• Study Completion Date: 2026-12-30

Brief 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.

Detailed Description

Epidural analgesia is the most effective and widely used analgesic method for relieving labor pain in clinical practice. However, inadvertent insertion of an epidural catheter into a blood vessel or subarachnoid space may result in local anesthesia or total spinal anesthesia, which can be life-threatening. Therefore, a low-concentration, low-volume dose of local anesthetic is usually injected as a test dose before injecting a large dose of local anesthetic through the epidural catheter to ensure that the catheter is within the epidural space. At present, the guidelines recommend 3 ml of 1.5% lidocaine as the test dose, but in clinical practice and the study of Chen et al., it was found that the test dose of 1.5% lidocaine 3ml still has a high incidence of lower limb motor block of 57.1%, which affects maternal activity and labor progression. In addition, Liu Henry et al. found that the incidence of 0.5% lidocaine 10 ml test dose-induced motor block was 0%, and the analgesic effect could be quickly achieved. Therefore, it is uncertain which concentration of lidocaine has the fastest onset of analgesia and the fewest side effects in labor analgesia. Therefore, this study aims to compare the effects of different concentrations of 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 clinical practice of labor analgesia.

Conditions

Labor Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1.5% Lidocaine

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

Group Type: ACTIVE_COMPARATOR

1.5% Lidocaine

Intervention Type: DRUG

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

Group Type: EXPERIMENTAL

1.0% Lidocaine

Intervention Type: DRUG

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

Group Type: EXPERIMENTAL

0.5% Lidocaine

Intervention Type: DRUG

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

Interventions

1.5% Lidocaine

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

Intervention Type: DRUG

1.0% Lidocaine

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

Intervention Type: DRUG

0.5% Lidocaine

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

Intervention Type: DRUG

Other Intervention Names

Lidocaine

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Second Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Bing Chen, Ph.D

Professor Bing Chen

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bing Chen

Role: PRINCIPAL_INVESTIGATOR

The Second Affiliated Hospital of Chongqing Medical University

Locations

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Countries

China

Other Identifiers

2024.276

Identifier Type: -

Identifier Source: org_study_id