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

Ain Shams University100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

100

Conditions

Pregnancy Related

Interventions

Epidural AnesthesiaPROCEDURE

Patients will receive epidural analgesia with 15 ml isobaric bupivacaine 0.125% plus fentanyl 2 μg/mL.

Spinal AnalgesiaPROCEDURE

Patients will receive Spinal analgesia with 5 mg bupivacaine and 25 μg of fentanyl in a 2 ml volume.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

Ain Shams University Hospitals

Cairo, Egypt

Outcomes

Primary Outcomes

The time to perform the block

The time from the preparation of the block until the full injection of anesthetic drugs,

Time frame: Intraoperative

Secondary Outcomes

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

Time frame: 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

Time frame: 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'

Time frame: First 24 hours postoperatively

Data from ClinicalTrials.gov

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