Spinal or Epidural Fentanyl or Sufentanil for Labour Pain in Early Phase of the Labour

Study Overview
=================
Brief Summary
-----------------
In this study the analgesic effect of two different opioids (fentanyl and sufentanil) will be compared when given either intrathecally or epidurally in primiparous parturients during early phase of the labour.

Official Title
-----------------
Spinal or Epidural Fentanyl or Sufentanil for Labour Pain in Early Phase of the Labour

Conditions
-----------------
Labor Pain

Intervention / Treatment
-----------------
* Drug: Spinal analgesia for labour pain
* Drug: Epidural analgesia for labour pain


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primiparous parturients In early phase of labour (cervical dilatation at or under 5 cm) No prior opioids by any route of administration within past 120 min Pain at or over 80 mm on 0-100 mm visual analog scale during contraction Exclusion Criteria: Allergy for any of the medications used Contraindications for epidural/spinal analgesia BMI at the time of delivery under 20 or over 35 kg/m2

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Spinal fentanyl<br>20 micrograms of intrathecally administered fentanyl in single dose. Total volume of intrathecal injection 2 ml. | Drug: Spinal analgesia for labour pain<br>* Intrathecal dose of either fentanyl or sufentanil delivered by combined spinal-epidural technique<br>|
| Experimental: Epidural fentanyl<br>100 micrograms of epidurally administered fentanyl in a single dose. Total volume of epidural injection 7 ml. | Drug: Epidural analgesia for labour pain<br>* Epidural dose of either fentanyl or sufentanil delivered through an epidural catheter.<br>* Other names: labour epidural;|
| Active Comparator: Spinal sufentanil<br>5 micrograms of intrathecally administered sufentanil in a single dose. Total volume of intrathecal injection 2 ml. | Drug: Spinal analgesia for labour pain<br>* Intrathecal dose of either fentanyl or sufentanil delivered by combined spinal-epidural technique<br>|
| Experimental: Epidural sufentanil<br>20 micrograms of epidurally administered sufentanil in a single dose. Total volume of epidural injection 7 ml. | Drug: Epidural analgesia for labour pain<br>* Epidural dose of either fentanyl or sufentanil delivered through an epidural catheter.<br>* Other names: labour epidural;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Maximum Pain During Contraction at 20 Minutes After the Study Drug Delivery | All parturients are to have a pain visual analog scale (VAS - on a 0-100 mm scale) at 80mm or higher before the initial study drug delivery. On this scale 0 mm presents a totally pain free condition while 100 mm presents the worst imaginable pain. The change of maximum pain in millimeters on the VAS scale during the 20 minutes following the study drug delivery will be recorded. | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Duration of Labour Analgesia After the Single Dose of Epidural or Intrathecal Opioid | The time from the study drug dose to the administration of next epidural bolus, up to five hours. After the study drug dose all parturients wil have epidural catheters in place for subsequent analgesia. | The data below report an average duration of time that is typically less than three hours |