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Active Not RecruitingNCT06819579

Exploring the Optimal Concentration of Lidocaine Test Dose for Labor Analgesia

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
99 (estimated)
Sponsor
The Second Affiliated Hospital of Chongqing Medical University · Academic / Other
Sex
Female
Age
20 Years – 40 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DRUG1.5% LidocaineAfter successful epidural puncture, 3ml of 1.5% lidocaine was injected as a test dose
DRUG1.0% LidocaineAfter successful epidural puncture, 5ml of 1% lidocaine was injected as a test dose
DRUG0.5% LidocaineAfter successful epidural puncture, 10ml of 0.5% lidocaine was injected as a test dose

Timeline

Start date
2025-03-10
Primary completion
2026-10-30
Completion
2026-12-30
First posted
2025-02-11
Last updated
2025-06-02

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT06819579. Inclusion in this directory is not an endorsement.