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

Women's Hospital HUS60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Labor Pain Induced; Birth

Interventions

Fentanyl CitrateDRUG

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

Lidocaine 1% Injectable SolutionDRUG

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

Fentanyl CitrateDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

HUS/Women's hospital dept of anaesthesia

Helsinki, Finland

Outcomes

Primary Outcomes

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.

Time frame: 20 minutes

Secondary Outcomes

Time until pain returns to 60 mm VAS

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

Time frame: 30-180 minutes

Ambulation during the analgesia provided by the intervention

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

Time frame: 30-180 minutes

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

Graded as normal, susceptible, pathological

Time frame: 0-30 minutes

Pruritus

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

Time frame: 0-30 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.

Time frame: at 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)

Time frame: 0-180 min

Data from ClinicalTrials.gov

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