Full Term Pregnancy, Labor Pain
Conditions
Brief summary
Patient controlled remifentanil analgesia might offer comparative overall patient satisfaction and improved quality of analgesia after normal labour with continuous epidural analgesia.
Detailed description
We are aiming to study the effects of patient controlled remifentanil analgesia and epidural analgesia for normal labour in full term parturients on: * Peripartum analgesia * Overall patient's satisfaction * Maternal adverse effects * Neonatal outcomes
Interventions
DRUGPatient-controlled remifentanil analgesia
Patient controlled remifentanil analgesia with a regimen to provide a bolus of 40 μg remifentanil with a lockout interval of 2 min
DRUGEpidural analgesia
Patients will receive continuous epidural analgesia using bupivacaine 0.125% in conjunction with fentanyl 2 ug/ml at a rate of 8-15 ml/hr
Sponsors
Cairo University
Alexandria University
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Gestational age \> 36 weeks * American Society of Anesthesiologists physical class I to III
Exclusion criteria
* Allergy to study solution * Contraindications to epidural analgesia * Non consented parturients * Communications barriers. * Intrauterine foetal growth retardation * Foetal distress
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall patient's satisfaction | For 24 hours after labour | As being assesses using 100-mm visual analog score (0: unsatisfied, 100: very satisfied) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal blood pH | For 5 min after birth | pH value |
| Neonatal Apgar score at 1 min | For 5 min after birth | Assessed using 5-points Apgar score |
| Neonatal Apgar score at 5 min | For 5 min after birth | Assessed using 5-points Apgar score |
| Neonatal blood PaO2 | For 5 min after birth | PaO2 value |
| Neonatal blood PaCO2 | For 5 min after birth | PaCO2 value |
| Pain Visual Analog Score on movement | For 24 hours after the start of labour pain | As being assesses using 10-cm visual analog score (0: no pain, 10: very agonising pain) |
| Maternal nausea and vomiting | For 24 hours after the start of labour pain | (0: no nausea or vomiting, 1: severe nausea, 3: vomiting) |
| Maternal respiratory depression | For 24 hours after the start of labour pain | If respiratory rate decreases less than 10/min |
| Pain Visual Analog Score at rest | For 24 hours after the start of labour pain | As being assesses using 10-cm visual analog score (0: no pain, 10: very agonising pain) |
Countries
Egypt
Outcome results
None listed