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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1.5% Lidocaine | Active Comparator | After successful epidural puncture, 3ml of 1.5% lidocaine was injected as a test dose |
|
| 1.0% Lidocaine | Experimental | After successful epidural puncture, 5ml of 1% lidocaine was injected as a test dose |
|
| 0.5% Lidocaine | Experimental | After successful epidural puncture, 10ml of 0.5% lidocaine was injected as a test dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1.5% Lidocaine | Drug | After successful epidural puncture, 3ml of 1.5% lidocaine was injected as a test dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain scores | Pain scores is assessed by the Numerical Pain Rating Scale (NPRS, where 0 means no pain and 10 means no pain tolerance) | 3,5,7,9,11,13,15,20,25,30 minutes after lidocaine administration |
| Time of analgesia onset |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bing Chen | The Second Affiliated Hospital of Chongqing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | 400000 | China |
Individual participant data (IPD) will be available with the responding author when required.
The data will become available when publish and keep it for 5 years.
Researchers who provide a methodologically sound proposal.
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| ID | Term |
|---|---|
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| 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 |
|
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.
| 3,5,7,9,11,13,15,20,25,30 minutes after lidocaine administration |
| Sensory block level | Midabdominal line acupuncture was used to assess the sensory block level | 3,5,7,9,11,13,15,20,25,30 minutes after lidocaine administration |
| 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. | 30 minutes after lidocaine administration |
| frequency and intensity of uterine contractions | A contraction monitor is used to monitor the intensity and frequency of contractions | 30 minutes after lidocaine administration |
| Maternal blood pressure | Automated monitoring with an ECG monitor | 5,10,15,20,25,30 minutes after lidocaine administration |
| Maternal heart rate | Automated monitoring with an ECG monitor | 5,10,15,20,25,30 minutes after lidocaine administration |
| Pulse oximetry (SPO2) | Automated monitoring with an ECG monitor | 5,10,15,20,25,30 minutes after lidocaine administration |
| fetal heart rate | Automatically monitored using a fetal heart rate monitor | 5,10,15,20,25,30 minutes after lidocaine administration |
| Patient satisfaction score | Numerical rating scale was used to score (0, completely dissatisfied; 1. Neutral; 2, satisfaction; 3, completely satisfied) | 30 minutes after lidocaine administration |
| First stage of labor | The first stage of labor begins when labor starts and ends with full cervical dilation to 10 centimeters. | From enrollment to 1 minute after the baby comes out. |
| Second stage of labor | The time from the cervix dilated to 10 centimeters to the baby comes out. | From enrollment to 1 minute after the baby comes out. |
| 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. | 1, 5, and 10 minutes after baby comes out. |
| Aniline Compounds |
| D000588 | Amines |