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

Ain Shams University1 site in 1 country100 target enrollmentSeptember 14, 2021

ConditionsPregnancy Related

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pregnancy Related
Sponsor: Ain Shams University
Enrollment: 100
Locations: 1
Primary Endpoint: The time to perform the block
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

September 14, 2021

End Date

October 1, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Ain Shams University

Responsible Party

Principal Investigator

Amin Mohammed Alansary Amin Ahmed Helwa

Associate Professor

Ain Shams University

Eligibility Criteria

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

Outcomes

Primary Outcomes

The time to perform the block

Time Frame: Intraoperative

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

Secondary Outcomes

Number of participnts with Postoperative nausea and vomiting (PONV)(First 24 hours postoperatively)
Mean arterial blood pressure (MAP)(Intraoperative)
Heart rate (HR)(Intraoperative)