Comparison of Programmed Intermittent Epidural Bolus With Continuous Epidural Infusion for Labor Epidural Analgesia
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: CEI 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 |
Procedure: Epidural analgesia
Procedure: Continuous epidural infusion
Drug: ropivacaine
Drug: sufentanil
|
| Active Comparator: PIEB 1 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 |
Procedure: Epidural analgesia
Procedure: Intermittent epidural bolus
Drug: ropivacaine
Drug: sufentanil
|
| Active Comparator: PIEB 2 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 |
Procedure: Epidural analgesia
Procedure: Intermittent epidural bolus
Drug: ropivacaine
Drug: sufentanil
|
Outcome Measures
Primary Outcome Measures
- Maternal visual analogue scale (VAS) [At time of initiation of analgesia and hourly thereafter until 1 hours postpartum (approximately 10 hours)]
a visual analog scale (VAS) with a 10 cm vertical score ranged from "no pain" to "worst possible pain"
Secondary Outcome Measures
- 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]
- 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)]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subjects who agree to join this study
-
Age: 22y-40y
-
American Society of Anesthesiologists (ASA) physical status 1 or 2
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Gestation : 37-41 weeks
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Primipara
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Singleton fetus and head presentation
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In early labor: cervical dilation for 1-3cm
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Requesting labor epidural analgesia
Exclusion Criteria:
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Contraindication for epidural analgesia
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Height less than 150 cm or more than 170 cm
-
Morbid obesity (BMI more than 35)
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High-risk pregnancy:(gestational diabetes mellitus, gestational hypertension, placenta previa, placental abruption, preeclampsia)
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Received parenteral opioids
-
Unable to perform motor block evaluation tests
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Obstetrics and Gynecology Hospital Affiliated to Nanjing Medical University | Nanjing | Jiangsu | China | 210004 |
Sponsors and Collaborators
- Nanjing Maternity and Child Health Care Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NJFY2016002