Labor Pain, Induced; Birth
Conditions
Keywords
epidural analgesia, spinal analgesia, labor pain
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.
Interventions
DRUGFentanyl Citrate
Fentanyl citrate 20 µg in 2 ml of saline injected into csf
Fentanyl citrate 100µg and lidocaine hydrochloride 80 mg in 10 ml volume
Sponsors
Women's Hospital HUS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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
Intervention model description
60 parturients randomized to two different treatment arms (30 in each group)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analgesia at 20 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ambulation during the analgesia provided by the intervention | 30-180 minutes | HAs the parturient been walking during the analgesia provided by the intervention |
| Changes in the cardiotocography (fetal heart rate) within 30 minutes after the intervention | 0-30 minutes | Graded as normal, susceptible, pathological |
| Pruritus | 0-30 minutes | The incidence of pruritus within 30 minutes after the intervention, graded: none, mild, moderate, severe, unbearable |
| Time until pain returns to 60 mm VAS | 30-180 minutes | Time from intervention until the maximum pain during contraction return to 60 mm on VAS scale |
| Cervical dilatation rate cm/h during the analgesia intervention | 0-180 min | (The cervical dilatation (1-10 cm) 1-3 hours post analgesia - The cervical dilatation (1-5 cm) before analgesia) / time between measurements (hours) |
| Use of oxytocin during the analgesia study period | 30 min | Oxytocin administered i.v. during 0-30 minutes after the analgesia (yes or no) |
| SAtisfaction of the parturient with the analgesia provided by the intervention | at 30 minutes | On 0-100 mm visual analog scale (VAS). Where 0 means no satisfaction at all and 100 mm means maximum satisfaction. |
Countries
Finland
Outcome results
None listed