Exploring the Optimal Concentration of Lidocaine Test Dose for Labor Analgesia

NCT06819579 | Active Not Recruiting

• 1 other identifier: 2024.276
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Pain

Outcome Measures

Primary Outcomes (1)

• The incidence of motor block

  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.

  3,5,7,9,11,13,15,20,25,30 minutes after lidocaine administration

Secondary Outcomes (13)

• Pain scores

  3,5,7,9,11,13,15,20,25,30 minutes after lidocaine administration

• Time of analgesia onset

  3,5,7,9,11,13,15,20,25,30 minutes after lidocaine administration

• Sensory block level

  3,5,7,9,11,13,15,20,25,30 minutes after lidocaine administration

• Incidence of complications related to labor analgesia

  30 minutes after lidocaine administration

• frequency and intensity of uterine contractions

  30 minutes after lidocaine administration

Study Arms (3)

1.5% Lidocaine

ACTIVE COMPARATOR

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

Drug: 1.5% Lidocaine

1.0% Lidocaine

EXPERIMENTAL

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

Drug: 1.0% Lidocaine

0.5% Lidocaine

EXPERIMENTAL

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

Drug: 0.5% Lidocaine

Interventions

1.5% Lidocaine DRUG

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

Also known as: Lidocaine

1.5% Lidocaine

1.0% Lidocaine DRUG

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

1.0% Lidocaine

0.5% Lidocaine DRUG

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

0.5% Lidocaine

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Singleton primipara
• Aged 20-40 years
• Pre-assessed as eligible for vaginal delivery
• Height between 155-170 cm, BMI between 18.5-35 kg/m²
• Cervical dilation between 2-6 cm
• No significant history of cardiopulmonary disease
• No history of surgical trauma
• American Society of Anesthesiologists (ASA) Grades I-III
• Patients are willing to participate and be able to understand and sign an informed consent form

You may not qualify if:

• Contraindications for spinal anesthesia, such as coagulopathy or ongoing anticoagulant therapy, infection at the puncture site, bacteremia, epidural abscess, increased intracranial pressure, severe hypovolemia
• Physical or mental disabilities, such as scoliosis and depression, alcohol or drug abuse
• Major organ diseases, such as hyperthyroidism, cardiopulmonary diseases, diabetes treated with insulin, and neuromuscular diseases
• Numerical Pain Rating Scale (NPRS) \< 5
• Refusal to participate in the study

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China

Location

MeSH Terms

Conditions

Labor Pain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Bing Chen

  The Second Affiliated Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Bing Chen

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: February 11, 2025
• Study Start: March 10, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: June 2, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will become available when publish and keep it for 5 years.
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

CN (1)