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Labor PainNCT06819579

Exploring the Optimal Concentration of Lidocaine Test Dose for Labor Analgesia

A study testing 1.5% Lidocaine, 1.0% Lidocaine and 0.5% Lidocaine in people with Labor Pain, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 40 years, women only
Conditions the study is for
Labor Pain
What is being tested?
1.5% Lidocaine, 1.0% Lidocaine and 0.5% Lidocaine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
99 participants
Where
1 siteChina
Study dates
10 Mar 2025to 30 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400000

Other trials in China

About this study

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.

Read the 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
Being tested
1.5% Lidocaine, 1.0% Lidocaine, 0.5% Lidocaine
Medical subject headings
Labor Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 1.5% LidocaineDrug

    Also called Lidocaine

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

  • 1.0% LidocaineDrug

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

  • 0.5% LidocaineDrug

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

Study groups in NCT06819579
Study groupRoleWhat they receive
1.5% LidocaineActive comparatorAfter successful epidural puncture, 3ml of 1.5% lidocaine was injected as a test dose
Receives: Drug: 1.5% Lidocaine
1.0% LidocaineExperimentalAfter successful epidural puncture, 5ml of 1% lidocaine was injected as a test dose
Receives: Drug: 1.0% Lidocaine
0.5% LidocaineExperimentalAfter successful epidural puncture, 10ml of 0.5% lidocaine was injected as a test dose
Receives: Drug: 0.5% Lidocaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (13)

  1. Pain scores

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

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

  2. Time of analgesia onset

    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.

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

  3. Sensory block level

    Midabdominal line acupuncture was used to assess the sensory block level

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

  4. Incidence of complications related to labor analgesia

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

    Measured: 30 minutes after lidocaine administration

  5. frequency and intensity of uterine contractions

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

    Measured: 30 minutes after lidocaine administration

  6. Maternal blood pressure

    Automated monitoring with an ECG monitor

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

  7. Maternal heart rate

    Automated monitoring with an ECG monitor

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

  8. Pulse oximetry （SPO2）

    Automated monitoring with an ECG monitor

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

  9. fetal heart rate

    Automatically monitored using a fetal heart rate monitor

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

  10. Patient satisfaction score

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

    Measured: 30 minutes after lidocaine administration

  11. First stage of labor

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

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

  12. Second stage of labor

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

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

  13. neonatal Apgar score

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2025
  2. Study start10 Mar 2025
  3. Primary completion30 Oct 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
99 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06819579
Sponsor's protocol ID
2024.276
Status last verified
Feb 2025
First submitted
24 Jan 2025
Last updated
2 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data (IPD) will be available with the responding author when required.

Questions about this trial

What is this clinical trial studying?

A study testing 1.5% Lidocaine, 1.0% Lidocaine and 0.5% Lidocaine in people with Labor Pain, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of motor block (time frame: 3,5,7,9,11,13,15,20,25,30 minutes after lidocaine administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06819579.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2025.

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