Neuroaxial Labour Analgesia

Study Overview
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Brief Summary
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The primary outcome of this clinical trial is to compare the pain scores during labour and delivery of combined spinal epidural without intrathecal opioids and dural puncture epidural The secondary objective of this study is to compare the and fetomaternal outcomes

Official Title
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A Randomized Comparison of Epidural, Dural Puncture Epidural and Combined Spinal Epidural Without Intrathecal Opioids for Labor Analgesia.

Conditions
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Labor Analgesia

Intervention / Treatment
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* Procedure: Dural Puncture Epidural Technique
* Procedure: Combined Spinal Epidural without intrathecal opioids
* Procedure: epidural


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Nulliparous parturient Singleton, vertex gestation at term (37-42 weeks) Less than 5 cm dilation request an epidural technique for labor analgesia Exclusion Criteria: Hypersensitivity to local the study drugs Clinically significant disease , including diseases of pregnancy (i.e preeclampsia, gestational diabetes) Any contraindication to the administration of an epidural technique Risk factor for cesarean delivery. fetal anomalies

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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 assignment placed in sealed envelopes.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: combined spinal epidural group<br>Bupivacaine 2.5 mg | Procedure: Combined Spinal Epidural without intrathecal opioids<br>* three labor analgesia techniques<br>|
| Active Comparator: dura puncture epidural group<br>Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 20 mL load over 5 min | Procedure: Dural Puncture Epidural Technique<br>* three labor analgesia techniques<br>|
| Active Comparator: epidural<br>Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 20 mL load over 5 min | Procedure: epidural<br>* three labor analgesia techniques<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| epidural Local anesthetic consumption |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal hypotension | maternal mean arterial blood pressure less than 50 mmhg | 1 year | 
| incidence of fetal bradycardia | a fetal heart rate of less than 100 beats per minute | 1 year | 
| incidence of maternal pruritus | Participants will be assessed for pruritus every hour, by grading the severity on a scale ranging from 0-3; 0 = none, 1 = mild, 2= moderate and 3 = severe | 1 year | 
| labour pain scores | Visual analogue scale with its 0 to 10 score range: (0 (no pain) to 10 ( Severe pain) | 1 year |