Comparative Study of the Loading Dose Administrated Via Epidural Needle or Epidural Catheter for Labor Analgesia

Study Overview
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Brief Summary
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Epidural anesthesia (EP) is widely used for labor analgesia. Time to onset of adequate pain relief of EP technique for labor analgesia may be 15 to 20 minutes.More rapid injection is often passible through the needle compared to catheter and could enhance the spread of medication within the epidural space.There is lack of research assessing the onset of labor analgesia with a large priming dose of local anesthetic through the epidural needle compared with the epidural catheter.

Detailed Description
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The epidural analgesia was performed in the left lateral decubitus position at the L3-L4 or L2-L3 interspace using a 18 G Tuohy needle. The epidural space was accessed by the loss of resistance to air or saline (2ml or less) technique. In the epidural needle group, after identification of epidural space, a dose of 3 ml of 0.1%ropivacaine with 0.3ug/ml sufentanil was given via the epidural needle ,3 minutes later labor analgesia was initiated with 15ml of 0.1 ropivacaine with 0.3ug/ml sufentanil over 30 seconds via the epidural needle, and then the catheter was inserted 3-5cm into the epidural space. In the epidural catheter group, the catheter was inserted 3-5cm into the epidural space after identification of epidural space, a dose of 3 ml of 0.1% ropivacaine with 0.3ug/ml sufentanil was given via the epidural catheter, 3minutes later labor analgesia was initiated with 15ml of 0.1%ropivacaine with 0.3ug/ml sufentanil as the same of group N.

Official Title
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Comparative Study of the Loading Dose Administrated Via Epidural Needle or Epidural Catheter for Labor Analgesia

Conditions
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Labor Pain

Intervention / Treatment
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* Procedure: epidural needle
* Procedure: epidural catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy, term (37-42 weeks' gestation), nulliparous women with singleton patients in active labor with a cervical dilation <5cm who planned labor analgesia Exclusion Criteria: any contraindication to neuraxial anesthesia, body mass index>50kg/m2, VAS <50mm on a 100-mm visual analog pain scales during an active contraction, 4. pregnancy-related diseases (ie, gestational hypertension, gestational diabetes, and preeclampsia), 5. the participants were in the event of an inadvertent dural puncture using the epidural needle, 6.fetal heart abnormity before labor analgesia.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: epidural needle<br>the loading dose for labor analgesia administrated via epidural needle before the catheter insertion. | Procedure: epidural needle<br>* the loading dose for labor analgesia administrated via epidural needle before the catheter insertion<br>|
| Active Comparator: epidural catheter<br>the loading dose for labor analgesia administrated via the epidural catheter. | Procedure: epidural catheter<br>* the loading dose for labor analgesia administrated via epidural catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time to onset of labor analgesia | Compare time of onset of labor analgesia and adequate analgesia was defined as VAS score<10mm in the presence of contraction. | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VSA scores | the Visual Analog Scale (VAS) on a 100-mm scale is measured during the labor . | 8 months | 
| number of PCEA bolus requests | the numbers of the patient -controlled epidural anangesia(PCEA) bolus of 5 ml with 15 minute lockout. | 8 months | 
| analgesia drug ( ropivacaine) requests | The total ropivacaine dose is recorded and is divided by the hours. | 8 months |