The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400000, China
NCT Number: NCT06819579
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.
This study is active but is not currently recruiting participants.
Notify Me20 year–40 year
Female
Interventional
Not applicable
Chongqing, Chongqing Municipality, 400000, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
After successful epidural puncture, 3ml of 1.5% lidocaine was injected as a test dose
Other names: Lidocaine
After successful epidural puncture, 5ml of 1% lidocaine was injected as a test dose
After successful epidural puncture, 10ml of 0.5% lidocaine was injected as a test dose
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.
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)
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.
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
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.
Time frame: 30 minutes after lidocaine administration
A contraction monitor is used to monitor the intensity and frequency of contractions
Time frame: 5,10,15,20,25,30 minutes after lidocaine administration
Automated monitoring with an ECG monitor
Time frame: 5,10,15,20,25,30 minutes after lidocaine administration
Automated monitoring with an ECG monitor
Time frame: 5,10,15,20,25,30 minutes after lidocaine administration
Automated monitoring with an ECG monitor
Time frame: 5,10,15,20,25,30 minutes after lidocaine administration
Automatically monitored using a fetal heart rate monitor
Time frame: 30 minutes after lidocaine administration
Numerical rating scale was used to score (0, completely dissatisfied; 1. Neutral; 2, satisfaction; 3, completely satisfied)
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.
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.
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.
The Second Affiliated Hospital of Chongqing Medical University
Other
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