Skip to main content
OpenTrials
Completed

NCT Number: NCT04645823

Spinal Fentanyl or Epidural Analgesia in the Early First Phase of Induced Labor

A total of 60 parturients undergoing induction of labour will be consented to participate in the study where they will be randomized to receive either spinal fentanyl (20 µg) or epidural analgesia (fentanyl 100µg and lidocaine 80 mg).

They will be monitored for the development of analgesia for a duration of 30 minutes.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Labor Pain Induced; Birth Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

HUS/Women's hospital dept of anaesthesia

Helsinki, 00029, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signs a consent form to participate voluntarily into the trial
  • Induced labor
  • singleton pregnancy
  • primiparous
  • BMI 20-40 at the time of delivery
  • No history of allergy for lidocaine or fentanyl
  • sufficient command of Finnish language to understand the consent form and interview
  • Cervical dilatation at maximum 4 cm at the time of intervention

Exclusion criteria

  • Any contraindication for spinal or epidural analgesia
  • Allergy for lidocaine or fentanyl
  • The patient has received any opioid medication within 90 minutes prior to intervention

Treatment and study plan

Fentanyl Citrate

Drug

Fentanyl citrate 20 µg in 2 ml of saline injected into csf

Lidocaine 1% Injectable Solution

Drug

Fentanyl citrate 100µg and lidocaine hydrochloride 80 mg in 10 ml volume

Primary outcomes

  1. Analgesia at 20 minutes

    Time frame: 20 minutes

    Reduction of visual analog scale (VAS) pain during contraction from pre-intervention value. 0 mm means no pain while 100 mm means worst possible pain.

Secondary outcomes

  1. Time until pain returns to 60 mm VAS

    Time frame: 30-180 minutes

    Time from intervention until the maximum pain during contraction return to 60 mm on VAS scale

  2. Ambulation during the analgesia provided by the intervention

    Time frame: 30-180 minutes

    HAs the parturient been walking during the analgesia provided by the intervention

  3. Changes in the cardiotocography (fetal heart rate) within 30 minutes after the intervention

    Time frame: 0-30 minutes

    Graded as normal, susceptible, pathological

  4. Pruritus

    Time frame: 0-30 minutes

    The incidence of pruritus within 30 minutes after the intervention, graded: none, mild, moderate, severe, unbearable

  5. SAtisfaction of the parturient with the analgesia provided by the intervention

    Time frame: at 30 minutes

    On 0-100 mm visual analog scale (VAS). Where 0 means no satisfaction at all and 100 mm means maximum satisfaction.

  6. Cervical dilatation rate cm/h during the analgesia intervention

    Time frame: 0-180 min

    (The cervical dilatation (1-10 cm) 1-3 hours post analgesia - The cervical dilatation (1-5 cm) before analgesia) / time between measurements (hours)

  7. Use of oxytocin during the analgesia study period

    Time frame: 30 min

    Oxytocin administered i.v. during 0-30 minutes after the analgesia (yes or no)

Sponsors and collaborators

Lead sponsor

Women's Hospital HUS

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 27, 2020
Registry last updated
Apr 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.