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

Women's Hospital HUS

Status and phase: Completed; Phase 4

Conditions: Induced; Birth; Labor Pain

Treatments: Drug: Lidocaine 1% Injectable Solution; Drug: Fentanyl Citrate

Study type: Interventional

Funder types: Other

Identifiers

NCT04645823

Versio4_22112020

2020-005506-26 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Spinal fentanyl

Active Comparator group

Description:

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.

Treatment:

Drug: Fentanyl Citrate

Drug: Fentanyl Citrate

Epidural lidocaine and fentanyl

Experimental group

Description:

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.

Treatment:

Drug: Fentanyl Citrate

Drug: Fentanyl Citrate

Drug: Lidocaine 1% Injectable Solution