Labor Analgesia
Conditions
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.
Interventions
PROCEDUREEpidural analgesia
PROCEDUREContinuous epidural infusion
PROCEDUREIntermittent epidural bolus
DRUGropivacaine
DRUGsufentanil
Sponsors
Nanjing Maternity and Child Health Care Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
22 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | 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) |
| Maternal respiratory rate | At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (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 blood pressure | At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours) |
| Durations of labor stages | From the beginning of regular contraction of uterus to the end of the labor (approximately 12 hours) |
Countries
China
Contacts
Primary ContactCaijuan Li, M.A.
Outcome results
None listed