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

NCT04645823 | Completed Phase 4

• 2 other identifiers: Versio4_221120202020-005506-26
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Labor Pain; Induced; Birth

Keywords

epidural analgesia; spinal analgesia; labor pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Time until pain returns to 60 mm VAS

  30-180 minutes

• Ambulation during the analgesia provided by the intervention

  30-180 minutes

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

  0-30 minutes

• Pruritus

  0-30 minutes

• SAtisfaction of the parturient with the analgesia provided by the intervention

  at 30 minutes

Study Arms (2)

Spinal fentanyl

ACTIVE COMPARATOR

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

Epidural lidocaine and fentanyl

EXPERIMENTAL

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: Lidocaine 1% Injectable Solution; Drug: Fentanyl Citrate

Interventions

Fentanyl Citrate DRUG

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

Spinal fentanyl

Lidocaine 1% Injectable Solution DRUG

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

Epidural lidocaine and fentanyl

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: All recruited patients are parturients undergoing induction of labor
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Women's Hospital HUS: lead

Study Sites (1)

HUS/Women's hospital dept of anaesthesia

Helsinki, 00029, Finland

Location

Related Publications (1)

• 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.

  PMID: 38366324 BACKGROUND

MeSH Terms

Conditions

Labor Pain

Interventions

Fentanyl; Lidocaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Antti J Vaananen, MD PhD

  HUCH, Women's hospital/dept of anesthesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The parturient and the midwife as well as the researcher doing the interview for analgesia will be masked. The anesthesiologist performing either spinal fentanyl administration or epidural analgesia will not be masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Model Details: 60 parturients randomized to two different treatment arms (30 in each group)

Study Record Dates

• First Submitted: November 22, 2020
• First Posted: November 27, 2020
• Study Start: March 26, 2021
• Primary Completion: May 19, 2023
• Study Completion: May 19, 2023
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)