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

Study Overview
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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.

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

Conditions
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Labor Pain, Induced; Birth

Intervention / Treatment
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* Drug: Fentanyl Citrate
* Drug: Lidocaine 1% Injectable Solution
* Drug: Fentanyl Citrate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 60 parturients randomized to two different treatment arms (30 in each group)
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Spinal fentanyl<br>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. | Drug: Fentanyl Citrate<br>* Fentanyl citrate 20 µg in 2 ml of saline injected into csf<br>|
| Experimental: Epidural lidocaine and fentanyl<br>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. | Drug: Lidocaine 1% Injectable Solution<br>* Fentanyl citrate 100µg and lidocaine hydrochloride 80 mg in 10 ml volume<br>Drug: Fentanyl Citrate<br>* Fentanyl citrate 100µg and lidocaine hydrochloride 80 mg in 10 ml volume<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesia at 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. | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time until pain returns to 60 mm VAS | Time from intervention until the maximum pain during contraction return to 60 mm on VAS scale | 30-180 minutes | 
| Ambulation during the analgesia provided by the intervention | HAs the parturient been walking during the analgesia provided by the intervention | 30-180 minutes | 
| Changes in the cardiotocography (fetal heart rate) within 30 minutes after the intervention | Graded as normal, susceptible, pathological | 0-30 minutes | 
| Pruritus | The incidence of pruritus within 30 minutes after the intervention, graded: none, mild, moderate, severe, unbearable | 0-30 minutes | 
| SAtisfaction of the parturient with the analgesia provided by the intervention | On 0-100 mm visual analog scale (VAS). Where 0 means no satisfaction at all and 100 mm means maximum satisfaction. | at 30 minutes | 
| Cervical dilatation rate cm/h during the analgesia intervention | (The cervical dilatation (1-10 cm) 1-3 h post analgesia - The cervical dilatation (1-5 cm) before analgesia) / time between measurements (h) | 0-180 min | 
| Use of oxytocin during the analgesia study period | Oxytocin administered i.v. during 0-30 min after the analgesia (yes or no) | 30 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epidural analgesia, spinal analgesia, labor pain