Labor Pain
Conditions
Keywords
Neurobehavior, Epidural analgesia, Local anesthetic, Opioid
Brief summary
Infant neurobehavior alteration is predictor of later intelligence development. Many factors would influence or are associated with infant neurobehavior, of which exist or appear during perinatal period. Neuraxial, especially epidural, analgesia to date is the most effective method in relieving labor pain. Although previous studies showed that opioid used in epidural analgesia for labor pain can affect newborn neurobehavior negatively in a dose-escalation associated manner, whether epidural analgesia itself would produce unpredictable effect on newborn neurobehavior is still unknown. Hereby the investigators designed this trial to investigate the hypothesis that epidural analgesia for labor pain control itself would not produce negative effect on infant neurobehavior.
Interventions
Ropivacaine 0.125% plus sufentanil 0.3 microgram
Sponsors
Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* \>18years and \<45years * Spontaneous labor * Analgesia request
Exclusion criteria
* Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records * Participants younger than 18 years or older than 45 years * Those who were not willing to or could not finish the whole study at any time * Using or used in the past 14 days of the monoamine oxidase inhibitors * Alcohol addictive or narcotic dependent patients were excluded for their influence on the analgesic efficacy of the epidural analgesics * Subjects with a nonvertex presentation or scheduled induction of labor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) | Immediate after birth (0 min) |
Secondary
| Measure | Time frame |
|---|---|
| Umbilical-cord gases analysis | At the time baby was born (0min) |
| Neonatal sepsis evaluation | One hour after the baby was born |
| Apgar scoring | One min and 5min after birth. |
| Incidence of maternal side effects | Analgesia initiation (0min) to successful vaginal delivery (this time encountered alteration with different women) |
| Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) | 10min after birth |
| Neonatal antibiotic treatment | One hour after the baby was born |
Countries
China
Outcome results
None listed