Trial | NCT04645823  Report issue

Official Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    60
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 Started
Mar 26
2021
Primary Completion
May 19
2023
Study Completion
May 19
2023
Last Update
Aug 30
2023

Drug Fentanyl Citrate

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

Drug Lidocaine 1% Injectable Solution

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

Drug Fentanyl Citrate

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

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.

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.

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

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
No Results Posted