Comparison of Programmed Intermittent Epidural Bolus With Continuous Epidural Infusion for Labor Epidural Analgesia

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Programmed Intermittent Epidural Bolus With Continuous Epidural Infusion for Labor Epidural Analgesia

Conditions
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Labor Analgesia

Intervention / Treatment
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* Procedure: Epidural analgesia
* Procedure: Continuous epidural infusion
* Procedure: Intermittent epidural bolus
* Drug: ropivacaine
* Drug: sufentanil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who agree to join this study Age: 22y-40y American Society of Anesthesiologists (ASA) physical status 1 or 2 Gestation : 37-41 weeks Primipara Singleton fetus and head presentation In early labor: cervical dilation for 1-3cm Requesting labor epidural analgesia Exclusion Criteria: Contraindication for epidural analgesia Height less than 150 cm or more than 170 cm Morbid obesity (BMI more than 35) High-risk pregnancy:(gestational diabetes mellitus, gestational hypertension, placenta previa, placental abruption, preeclampsia) Received parenteral opioids Unable to perform motor block evaluation tests

Ages Eligible for Study
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Minimum Age: 22 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CEI<br>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<br> <br> Procedure: Continuous epidural infusion<br> <br> Drug: ropivacaine<br> <br> Drug: sufentanil<br> <br> |
| Active Comparator: PIEB 1<br>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<br> <br> Procedure: Intermittent epidural bolus<br> <br> Drug: ropivacaine<br> <br> Drug: sufentanil<br> <br> |
| Active Comparator: PIEB 2<br>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<br> <br> Procedure: Intermittent epidural bolus<br> <br> Drug: ropivacaine<br> <br> Drug: sufentanil<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Total ropivacaine and sufentanil consumption |  | At two hours postpartum | 
| Proportion of parturients requiring additional PCEA boluses |  | At two hours postpartum | 
| Rate of very satisfiedand/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) |