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.

Study Overview

• Status: Completed
• Conditions: Labor Pain; Induced; Birth
• Intervention / Treatment: Drug: Fentanyl Citrate; Drug: Fentanyl Citrate; Drug: Lidocaine 1% Injectable Solution

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland, 00029
    • HUS/Women's hospital dept of anaesthesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Spinal fentanyl; Using a combined spinal epidural technique a single dose of 20 µg of fentanyl diluted into 2 ml with NaCl 0.9 % will be injected into the CSF at lower lumbar interspace. An epidural catheter is left in place for subsequent analgesic doses.	Drug: Fentanyl Citrate; Fentanyl citrate 20 µg in 2 ml of saline injected into csf; Drug: Fentanyl Citrate; Fentanyl citrate 100µg and lidocaine hydrochloride 80 mg in 10 ml volume
Experimental: Epidural lidocaine and fentanyl; Using a catheter in the epidural space in the lower lumbar interspace a single dose of lidocaine (80 mg) and fentanyl (100 µg) is given. The epidural catheter is left in place for subsequent analgesic doses.	Drug: Fentanyl Citrate; Fentanyl citrate 20 µg in 2 ml of saline injected into csf; Drug: Fentanyl Citrate; Fentanyl citrate 100µg and lidocaine hydrochloride 80 mg in 10 ml volume; Drug: Lidocaine 1% Injectable Solution; Fentanyl citrate 100µg and lidocaine hydrochloride 80 mg in 10 ml volume

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analgesia at 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.	20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time until pain returns to 60 mm VAS	Time from intervention until the maximum pain during contraction return to 60 mm on VAS scale	30-180 minutes
Ambulation during the analgesia provided by the intervention	HAs the parturient been walking during the analgesia provided by the intervention	30-180 minutes
SAtisfaction of the parturient with the analgesia provided by the intervention	On 0-100 mm visual analog scale (VAS). Where 0 means no satisfaction at all and 100 mm means maximum satisfaction.	at 30 minutes
Changes in the cardiotocography (fetal heart rate) within 30 minutes after the intervention	Graded as normal, susceptible, pathological	0-30 minutes
Pruritus	The incidence of pruritus within 30 minutes after the intervention, graded: none, mild, moderate, severe, unbearable	0-30 minutes
Cervical dilatation rate cm/h during the analgesia intervention	(The cervical dilatation (1-10 cm) 1-3 hours post analgesia - The cervical dilatation (1-5 cm) before analgesia) / time between measurements (hours)	0-180 min
Use of oxytocin during the analgesia study period	Oxytocin administered i.v. during 0-30 minutes after the analgesia (yes or no)	30 min

Collaborators and Investigators

• Sponsor: Women's Hospital HUS
• Investigators: Principal Investigator: Antti J Vaananen, MD PhD, HUCH, Women's hospital/dept of anesthesia

Publications and helpful links

General Publications

• Salmi L, Jernman R, Vaananen A. Is epidural analgesia non-inferior to intrathecal fentanyl as initiation for neuraxial analgesia in early non-spontaneous labour? Acta Anaesthesiol Scand. 2024 May;68(5):664-674. doi: 10.1111/aas.14389. Epub 2024 Feb 16.

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2021
• Primary Completion (Actual): May 19, 2023
• Study Completion (Actual): May 19, 2023

Study Registration Dates

• First Submitted: November 22, 2020
• First Submitted That Met QC Criteria: November 22, 2020
• First Posted (Actual): November 27, 2020

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: epidural analgesia; labor pain; spinal analgesia
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Membrane Transport Modulators; Adjuvants, Anesthesia; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Anticoagulants; Chelating Agents; Sequestering Agents; Calcium Chelating Agents; Fentanyl; Lidocaine; Citric Acid; Sodium Citrate
• Other Study ID Numbers: Versio4_22112020; 2020-005506-26 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No