Clinical trial NCT02873091: Comparison of Programmed Intermittent Epidural Bolus With Continuous Epidural Infusion for Labor Epidural Analgesia
Official title: Comparison of Programmed Intermittent Epidural Bolus With Continuous Epidural Infusion for Labor Epidural Analgesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Labor Analgesia
Lead sponsor: Nanjing Maternity and Child Health Care Hospital
Sponsor class: OTHER
First posted: 2016-08-19
Enrollment: 186
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Maternal visual analogue scale (VAS)
timeFrame: At time of initiation of analgesia and hourly thereafter until 1 hours postpartum (approximately 10 hours)
Secondary outcomes:
measure: Maternal modified Bromage scale
timeFrame: At time of initiation of analgesia and hourly thereafter until 2 hours postpartum (approximately 10 hours)
measure: Subject's Satisfaction with labor epidural analgesia
timeFrame: At the time after childbirth
measure: Total ropivacaine and sufentanil consumption
timeFrame: At two hours postpartum
measure: Proportion of parturients requiring additional PCEA boluses
timeFrame: At two hours postpartum
measure: Rate of "very satisfied"and/or "satisfied",Proportion of subjects who has experienced Visual analog scale (VAS) score for pain more than 3 scale
timeFrame: At two hours postpartum
measure: Maternal heart rate
timeFrame: At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)
measure: Rates of cesarean delivery and instrument-assisted delivery
timeFrame: At time of placental delivery
measure: Duration of analgesia
timeFrame: Initiation of analgesia to 2 h postpartum (approximately 10 hours)
measure: Durations of labor stages
timeFrame: From the beginning of regular contraction of uterus to the end of the labor (approximately 12 hours)
measure: Use of oxytocin after analgesia
timeFrame: At twenty-four hours postpartum
measure: Incidence of maternal side effects
timeFrame: Initiation of analgesia to 2 hour postpartum (approximately 10 hours)
measure: Neonatal Apgar scale
timeFrame: At the first and fifth minutes after baby was born
measure: Fetal heart rate
timeFrame: From initiation of analgesia to delivery (approximately 8 hours)
measure: Neonatal weight
timeFrame: At delivery
measure: Mean number of PCEA
timeFrame: At two hours postpartum
measure: Maternal respiratory rate
timeFrame: At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)
measure: Maternal blood pressure
timeFrame: At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Obstetrics and Gynecology Hospital Affiliated to Nanjing Medical University
state: Jiangsu
Study officials:
References: