Spinal or Epidural Fentanyl or Sufentanil for Labour Pain in Early Phase of the Labour

Helsinki University Central Hospital (HUCH)

Status and phase: Completed; Phase 4

Conditions: Labor Pain

Treatments: Drug: Epidural analgesia for labour pain; Drug: Spinal analgesia for labour pain

Study type: Interventional

Funder types: Other

Identifiers

NCT02885350

§12/19.6.2016/HUS/400/2016

2016-000486-23 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 4 patient groups

Spinal fentanyl

Active Comparator group

Description:

20 micrograms of intrathecally administered fentanyl in single dose. Total volume of intrathecal injection 2 ml.

Treatment:

Drug: Spinal analgesia for labour pain

Epidural fentanyl

Experimental group

Description:

100 micrograms of epidurally administered fentanyl in a single dose. Total volume of epidural injection 7 ml.

Treatment:

Drug: Epidural analgesia for labour pain

Spinal sufentanil

Active Comparator group

Description:

5 micrograms of intrathecally administered sufentanil in a single dose. Total volume of intrathecal injection 2 ml.

Treatment:

Drug: Spinal analgesia for labour pain

Epidural sufentanil

Experimental group

Description:

20 micrograms of epidurally administered sufentanil in a single dose. Total volume of epidural injection 7 ml.

Treatment:

Drug: Epidural analgesia for labour pain