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Sixteen million babies were born in 2010, approximately half were by cesarean. Labor analgesia should be the first choice for these parturients based on the consideration of security and humanization. However this labor analgesia rate is quite low in China (<5%) while in western country, this rate is up to 60%. Programmed intermittent epidural bolus (PIEB) is the latest technique for labor analgesia which has less neurotoxicity theoretically compared with Continuous Epidural Infusion(CEI) with Patient controlled epidural analgesia (PCEA) which is used most commonly. In that study, they reported less total local anesthetic consumption, fewer manual bolus doses and greater patient satisfaction with the PIEB technique. In China, multiple factors contribute to the reasons of low labor analgesia rate. From the patient's point of view, worrying about unsatisfied analgesia, and not adapted to the symptoms of motor block, such as inability to move their legs distressing, both are important reasons of refusing labor analgesia and preferring to cesarean delivery. Therefore, in this clinical trial, we plan to find a safer and more effective regimen for labor analgesia in Chineseparturients. This clinical trial is designed to prove PIEB used Ropivacaine is safer and more effective than CEI for labor analgesia in Chinese parturients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CEI | Active Comparator | Initial loading dose:10 ml (0.125% ropivacaine with 0.4 μg/ml sufentanil) Epidural infusion with maintain dose: 0.08% ropivacaine with 0.4 μg/ml sufentanil. The basal infusion of CEI: 10 ml/h, beginning immediately after the initial dose |
|
| PIEB 1 | Active Comparator | Initial loading dose:10 ml (0.125% ropivacaine with 0.4 μg/ml sufentanil) Epidural infusion with maintain dose: 0.08% ropivacaine with 0.4 μg/ml sufentanil.The basal infusion of PIEB1: 5 ml per 30 min, beginning 30 min after the initial dose |
|
| PIEB 2 | Active Comparator | Initial loading dose:10 ml (0.125% ropivacaine with 0.4 μg/ml sufentanil) Epidural infusion with maintain dose: 0.08% ropivacaine with 0.4 μg/ml sufentanil. The basal infusion of PIEB2: 10 ml per 60 min, beginning 60 min after the initial dose |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epidural analgesia | Procedure |
| ||
| Continuous epidural infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal visual analogue scale (VAS) | a visual analog scale (VAS) with a 10 cm vertical score ranged from "no pain" to "worst possible pain" | At time of initiation of analgesia and hourly thereafter until 1 hours postpartum (approximately 10 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal modified Bromage scale | At time of initiation of analgesia and hourly thereafter until 2 hours postpartum (approximately 10 hours) | |
| Subject's Satisfaction with labor epidural analgesia | At the time after childbirth |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caijuan Li, M.A. | Contact | 025-52226112 | licaijuanyumi1228@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Obstetrics and Gynecology Hospital Affiliated to Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210004 | China |
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| Procedure |
|
| Intermittent epidural bolus | Procedure |
|
| ropivacaine | Drug |
|
| sufentanil | Drug |
|
| Total ropivacaine and sufentanil consumption | At two hours postpartum |
| Proportion of parturients requiring additional PCEA boluses | At two hours postpartum |
| Rate of "very satisfied"and/or "satisfied",Proportion of subjects who has experienced Visual analog scale (VAS) score for pain more than 3 scale | At two hours postpartum |
| Maternal heart rate | At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours) |
| Rates of cesarean delivery and instrument-assisted delivery | At time of placental delivery |
| Duration of analgesia | Initiation of analgesia to 2 h postpartum (approximately 10 hours) |
| Durations of labor stages | From the beginning of regular contraction of uterus to the end of the labor (approximately 12 hours) |
| Use of oxytocin after analgesia | At twenty-four hours postpartum |
| Incidence of maternal side effects | Initiation of analgesia to 2 hour postpartum (approximately 10 hours) |
| Neonatal Apgar scale | At the first and fifth minutes after baby was born |
| Fetal heart rate | From initiation of analgesia to delivery (approximately 8 hours) |
| Neonatal weight | At delivery |
| Mean number of PCEA | At two hours postpartum |
| Maternal respiratory rate | At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours) |
| Maternal blood pressure | At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours) |
| ID | Term |
|---|---|
| D015360 | Analgesia, Epidural |
| D000077212 | Ropivacaine |
| D017409 | Sufentanil |
| ID | Term |
|---|---|
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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