Spinal or Epidural Fentanyl or Sufentanil for Labour Pain in Early Phase of the Labour
Overview
- Phase
- Phase 4
- Intervention
- Spinal analgesia for labour pain
- Conditions
- Labor Pain
- Sponsor
- Helsinki University Central Hospital
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Change of Maximum Pain During Contraction at 20 Minutes After the Study Drug Delivery
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
In this study the analgesic effect of two different opioids (fentanyl and sufentanil) will be compared when given either intrathecally or epidurally in primiparous parturients during early phase of the labour.
Investigators
Jouni Ahonen
MD, Ph.D.
Helsinki University Central Hospital
Eligibility Criteria
Inclusion Criteria
- •Primiparous parturients
- •In early phase of labour (cervical dilatation at or under 5 cm)
- •No prior opioids by any route of administration within past 120 min
- •Pain at or over 80 mm on 0-100 mm visual analog scale during contraction
Exclusion Criteria
- •Allergy for any of the medications used
- •Contraindications for epidural/spinal analgesia
- •BMI at the time of delivery under 20 or over 35 kg/m2
Arms & Interventions
Spinal fentanyl
20 micrograms of intrathecally administered fentanyl in single dose. Total volume of intrathecal injection 2 ml.
Intervention: Spinal analgesia for labour pain
Epidural fentanyl
100 micrograms of epidurally administered fentanyl in a single dose. Total volume of epidural injection 7 ml.
Intervention: Epidural analgesia for labour pain
Spinal sufentanil
5 micrograms of intrathecally administered sufentanil in a single dose. Total volume of intrathecal injection 2 ml.
Intervention: Spinal analgesia for labour pain
Epidural sufentanil
20 micrograms of epidurally administered sufentanil in a single dose. Total volume of epidural injection 7 ml.
Intervention: Epidural analgesia for labour pain
Outcomes
Primary Outcomes
Change of Maximum Pain During Contraction at 20 Minutes After the Study Drug Delivery
Time Frame: 20 minutes
All parturients are to have a pain visual analog scale (VAS - on a 0-100 mm scale) at 80mm or higher before the initial study drug delivery. On this scale 0 mm presents a totally pain free condition while 100 mm presents the worst imaginable pain. The change of maximum pain in millimeters on the VAS scale during the 20 minutes following the study drug delivery will be recorded.
Secondary Outcomes
- The Duration of Labour Analgesia After the Single Dose of Epidural or Intrathecal Opioid(The data below report an average duration of time that is typically less than three hours)