Comparison of Epidural Labor Pain Relief Techniques on Maternal and Fetal Outcomes

Study Overview
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Brief Summary
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The primary objective of this study is to compare the onset and duration of the initial dose of medications given through three different epidural (conventional epidural, combined spinal epidural and dural puncture epidural) techniques for labor pain relief. The secondary objective of this study is to compare the fetal effects of these three epidural labor analgesia techniques.

Official Title
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Comparison of Epidural Labor Pain Relief Techniques on Maternal and Fetal Outcomes

Conditions
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Laboring Women Requesting Neuraxial Labor Analgesia

Intervention / Treatment
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* Procedure: Epidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural Technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Nulliparous (first baby) parturient 2. Singleton, vertex gestation at term (37-42 weeks) 3. Less than 5 cm dilation 4. Desires an epidural technique for labor analgesia Exclusion Criteria: - 1. Current or historical evidence of clinically significant disease or condition, including diseases of pregnancy (i.e preeclampsia, gestational diabetes) 2. Any contraindication to the administration of an epidural technique 3. History of hypersensitivity or idiosyncratic reaction to local anesthetic or opioid medications 4. Current or historical evidence of a disease which may result in the risk of a cesarean delivery. 5. Evidence of anticipated fetal anomalies

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: Randomized controlled trial with computer generated (Microsoft Excel 2015) assignment placed in sealed envelopes.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Epidural Technique<br>Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 15 mL load over 5 min | Procedure: Epidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural Technique<br>* Three different techniques, using the same medications (bupivacaine and fentanyl)<br>|
| Active Comparator: Combined Spinal Epidural Technique<br>Bupivacaine 2.5 mg with Fentanyl 25 mcg | Procedure: Epidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural Technique<br>* Three different techniques, using the same medications (bupivacaine and fentanyl)<br>|
| Active Comparator: Dural Puncture Epidural Technique<br>Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 15 mL load over 5 min | Procedure: Epidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural Technique<br>* Three different techniques, using the same medications (bupivacaine and fentanyl)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal Outcomes | Onset, quality, and duration of analgesia, occurrences of hypotension, bradycardia, pruritus, nausea, emesis. | Participants will be followed for the duration of labor analgesia from initiation to delivery, an expected average of 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fetal Outcomes | Occurrence of fetal bradycardia or other heart rate changes, changes in fetal heart tracing patterns | Participants will be followed for the duration of labor analgesia from initiation to delivery, an expected average of 12 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuraxial Technique, Epidural Technique, Dural Puncture Epidural Technique, Combined Spinal Epidural Technique, Labor Analgesia, Obstetric