Spinal Fentanyl or Epidural Analgesia in the Early First Phase of Induced Labor
- Conditions
- Induced; BirthLabor Pain
- Interventions
- Registration Number
- NCT04645823
- Lead Sponsor
- Women's Hospital HUS
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Spinal fentanyl Fentanyl Citrate 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 Lidocaine 1% Injectable Solution 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. Epidural lidocaine and fentanyl Fentanyl Citrate 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Pruritus 0-30 minutes The incidence of pruritus within 30 minutes after the intervention, graded: none, mild, moderate, severe, unbearable
Changes in the cardiotocography (fetal heart rate) within 30 minutes after the intervention 0-30 minutes Graded as normal, susceptible, pathological
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
Ambulation during the analgesia provided by the intervention 30-180 minutes HAs the parturient been walking during the analgesia provided by the intervention
Use of oxytocin during the analgesia study period 30 min Oxytocin administered i.v. during 0-30 minutes after the analgesia (yes or no)
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)
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.
Trial Locations
- Locations (1)
HUS/Women's hospital dept of anaesthesia
🇫🇮Helsinki, Finland