Epidural Versus Low-dose Spinal for Analgesia of Late First Stage of Labor

Study Overview
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Brief Summary
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The aim of this study is to compare the effect of epidural analgesia versus low-dose spinal analgesia in parturient in the late first stage of labor regarding time needed to perform the block, duration of the intra- and postoperative analgesia and incidence of procedure related adverse events.

Official Title
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Epidural Versus Low-dose Spinal for Analgesia of Late First Stage of Labor: A Randomized Clinical Trial

Conditions
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Pregnancy Related

Intervention / Treatment
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* Procedure: Epidural Anesthesia
* Procedure: Spinal Analgesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parturient with normal vaginal delivery in late first stage of labor (cervical dilatation ≥ 6 cm by examination) Aged 18-40 years old Single, term pregnant with normal fetal heart rate Request neuroaxial analgesia Exclusion Criteria: Parturient who refuses to participate, American Society of Anesthesiologists (ASA) physical status >II, Body mass index more than 35 kg/m2 Severe pre-eclampsia or eclampsia Uncontrolled thyrotoxicosis Cardiovascular troubles (e.g. stenotic valvular heart disease or cardiomyopathy) Increased intracranial tension due to a space-occupying lesion Any contraindication to regional anesthesia such as local skin or soft tissue infection, coagulopathy or receiving anticoagulant therapy, thrombocytopenic, uncorrected hypovolemia, preexisting neurologic deficits, spinal deformity or previous spine surgery. Hypersensitivity to the study drugs Parturient who scheduled for emergency cesarean section due to fetal distress, antepartum hemorrhage, multiple gestation or fetal malpresentation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Epidural Anesthesia<br>Patients will receive epidural analgesia with 15 ml isobaric bupivacaine 0.125% plus fentanyl 2 μg/mL | Procedure: Epidural Anesthesia<br>* Patients will receive epidural analgesia with 15 ml isobaric bupivacaine 0.125% plus fentanyl 2 μg/mL.<br>|
| Active Comparator: Spinal Anesthesia<br>Patients will receive Spinal analgesia with 5 mg bupivacaine and 25 μg of fentanyl in a 2 ml volume. | Procedure: Spinal Analgesia<br>* Patients will receive Spinal analgesia with 5 mg bupivacaine and 25 μg of fentanyl in a 2 ml volume.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time to perform the block | The time from the preparation of the block until the full injection of anesthetic drugs, | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean arterial blood pressure (MAP) | MAP will be recorded at baseline; 5 minutes prior to the neuroaxial block, and at 5 minutes, 10 minutes, 15 minutes, and 20 minutes after the injection of the local anesthetic and then every 15 minutes till the end of third stage of labor | Intraoperative | 
| Heart rate (HR) | HR will be recorded at baseline; 5 minutes prior to the neuroaxial block, and at 5 minutes, 10 minutes, 15 minutes, and 20 minutes after the injection of the local anesthetic and then every 15 minutes till the end of third stage of labor | Intraoperative | 
| Number of participnts with Postoperative nausea and vomiting (PONV) | PONV will be recorded and categorized as 'no PONV, mild PONV, moderate PONV, and severe PONV' | First 24 hours postoperatively |