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NCT Number: NCT06819579

Exploring the Optimal Concentration of Lidocaine Test Dose for Labor Analgesia

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

1.5% Lidocaine

Drug

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

Other names: Lidocaine

1.0% Lidocaine

Drug

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

0.5% Lidocaine

Drug

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

Primary outcomes

  1. The incidence of motor block

    Time frame: 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.

Secondary outcomes

  1. Pain scores

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

    Pain scores is assessed by the Numerical Pain Rating Scale (NPRS, where 0 means no pain and 10 means no pain tolerance)

  2. Time of analgesia onset

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

    Pain scores is assessed by the Numerical Pain Rating Scale (NPRS, where 0 means no pain and 10 means no pain tolerance). Analgesia is considered effective when NPRS is ≤3 or NPRS is reduced by ≥ 50% of the baseline value.

  3. Sensory block level

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

    Midabdominal line acupuncture was used to assess the sensory block level

  4. Incidence of complications related to labor analgesia

    Time frame: 30 minutes after lidocaine administration

    Ask the patient if they have discomfort such as leg warmth, leg numbness, trembling, itching, headache, tinnitus, etc.

  5. frequency and intensity of uterine contractions

    Time frame: 30 minutes after lidocaine administration

    A contraction monitor is used to monitor the intensity and frequency of contractions

  6. Maternal blood pressure

    Time frame: 5,10,15,20,25,30 minutes after lidocaine administration

    Automated monitoring with an ECG monitor

  7. Maternal heart rate

    Time frame: 5,10,15,20,25,30 minutes after lidocaine administration

    Automated monitoring with an ECG monitor

  8. Pulse oximetry (SPO2)

    Time frame: 5,10,15,20,25,30 minutes after lidocaine administration

    Automated monitoring with an ECG monitor

  9. fetal heart rate

    Time frame: 5,10,15,20,25,30 minutes after lidocaine administration

    Automatically monitored using a fetal heart rate monitor

  10. Patient satisfaction score

    Time frame: 30 minutes after lidocaine administration

    Numerical rating scale was used to score (0, completely dissatisfied; 1. Neutral; 2, satisfaction; 3, completely satisfied)

  11. First stage of labor

    Time frame: From enrollment to 1 minute after the baby comes out.

    The first stage of labor begins when labor starts and ends with full cervical dilation to 10 centimeters.

  12. Second stage of labor

    Time frame: From enrollment to 1 minute after the baby comes out.

    The time from the cervix dilated to 10 centimeters to the baby comes out.

  13. neonatal Apgar score

    Time frame: 1, 5, and 10 minutes after baby comes out.

    The Apgar score is to evaluate the presence or absence of neonatal asphyxia and the severity of asphyxia from five aspects: Appearance, Pulse, Grimace, Activity and Respiration after birth, with each item being 0~2 points and a full score of 10 points.

Sponsors and collaborators

Lead sponsor

The Second Affiliated Hospital of Chongqing Medical University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 11, 2025
Registry last updated
Jun 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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