Phase 4
N=80
Spinal or Epidural Fentanyl or Sufentanil for Labour Pain in Early Phase of the Labour
Labor Pain
Bottom Line
View on ClinicalTrials.gov: NCT02885350 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
May 2021
Primary outcome: Primary: Change of Maximum Pain During Contraction at 20 Minutes After the Study Drug Delivery — 60; 36; 67; 42 mm
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Spinal analgesia for labour pain (Drug); Epidural analgesia for labour pain (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Helsinki University Central Hospital
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Maximum Pain During Contraction at 20 Minutes After the Study Drug Delivery |
60; 36; 67; 42 | — |
| SECONDARY The Duration of Labour Analgesia After the Single Dose of Epidural or Intrathecal Opioid |
177; 112; 151; 130 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02885350). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.