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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-26

Study Completion Date

2023-05-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Labor Pain Induced; Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Fentanyl Citrate

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Lidocaine 1% Injectable Solution

Intervention Type DRUG

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

Fentanyl Citrate

Intervention Type DRUG

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

Interventions

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Fentanyl Citrate

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

Intervention Type DRUG

Lidocaine 1% Injectable Solution

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

Intervention Type DRUG

Fentanyl Citrate

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No