Trial intelligence / Profile preview

Unilateral Block in Repeated Epidural Anesthesia

NCT03806673Phase 4

Key facts

Status: Completed
Start: Feb 2018
Primary completion: Sep 2018
Countries: 1
Sponsor: Ain Shams University
Modality: Small Molecules

Drugs: bupivacaine
Conditions: labor pain

Overview

Phase 4, randomised, open-label trial of bupivacaine in labor pain (2 arms), sponsored by Ain Shams University. Primary endpoint: Cold sensation test at 30 minutes. Started Feb 2018; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

Primipara
Women receiving their first epidural block
Multipara
Women receiving repeated epidural block

Who it enrols

Healthy ASA II women aged 20-40 scheduled for normal vaginal delivery, excluding those with physical reasons for difficult epidural, severe hypertension, heart failure, coagulopathy, or significant hepatic/renal disease.

Endpoints

Primary

Cold sensation test30 minutes

Secondary

Incidence of unilateral epidural block30 minutes
Visual Analogue Scale30 minutes
Ease of catheter insertionduring procedure
Occurrence of blood in needle or catheterduring procedure

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