CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 216 enrolled
Drug / intervention
Bupivacaine +3 moredrug
Likely dose
Bupivacaine 12.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00921102
NCT00921102Phase 4Completed

Intrathecal Atropine to Prevent Nausea and Vomiting After Spinal Anesthesia With Morphine for Elective Caesarean Section: a Randomized Controlled Trial

University of Parma·interventional·Posted Jun 16, 2009·Updated Jun 16, 2009

In Brief

A Phase 4 clinical trial evaluating Bupivacaine, Morphine, and 2 other interventions for Cesarean Section and 2 related conditions. Completed, enrolled 216 participants across 2 sites.

Detailed Summary

The aim of this study is to assess the efficacy of atropine in preventing nausea and vomiting after spinal anesthesia with local anesthetic and morphine for elective Caesarean section. Patients enrolling in the study will be assigned to one of three groups. One will receive a small dose of intrathecal atropine; another will receive small-dose intravenous atropine; the third group will receive placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 16, 2009
Enrollment StartMay 1, 2007
Primary CompletionFeb 1, 2008
Study CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 17.0 years ago

Interventions

Bupivacainedrug

12.5 mg of a 5 mg/ml hyperbaric solution, intrathecally

Morphinedrug

200 µg of a 200 µg/ml solution, intrathecally

Isotonic saline solutiondrug

0.9% NaCl solution 0.1 ml, intrathecally in group Control and IV Atropine 0.1 ml, intravenously in group Control and Intrathecal Atropine

Atropinedrug

100 µg of a 1 mg/ml preservative-free solution * intrathecally in group Intrathecal Atropine * intravenously in group IV Atropine