CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 58 enrolled
Drug / intervention
Vasopressindrug
Likely dose
Vasopressin 20unitsfrom record
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Search/NCT00799292
NCT00799292Phase 4Completed

Effects of Cervical Vasopressin Versus no Premedication on Blood Loss During Vaginal Hysterectomy

Ascher-Walsh, Charles, M.D.·interventional·Posted Nov 27, 2008·Updated Jul 24, 2018

In Brief

A Phase 4 clinical trial evaluating Vasopressin for Blood Loss During Vaginal Hysterectomy. Completed, enrolled 58 participants across 1 site.

Detailed Summary

Vasoconstrictive agents are increasingly being used in order to decrease blood loss during vaginal hysterectomy. The first reported study of the use of a vasoconstrictive agent for this purpose was on the use of epinephrine injected intracervically preoperatively by England, et. al. They demonstrated a significant decrease in the amount of blood lost during the surgery but also demonstrated a significant increase in the risk of post-operative infections, most frequently a vaginal cuff cellulitis requiring antibiotic treatment. Recent studies using vasopressin as the vasoconstrictive agent have also found the same significant decrease in blood loss while not demonstrating a difference in the rate of post-operative infections. The more recent studies by Speer and Unger , and Kammerer-Doak, et.al. were larger, better designed studies and are considered more credible. More surgeons are therefore injecting vasopressin intracervically preoperatively. Some surgeons believe that the injection of vasopressin intracervically prior to the initial incision of a vaginal hysterectomy effects surgical plains and therefore makes the surgical dissection more difficult. This is thought to possibly both add to operative time and increase the rate of complications. The aforementioned studies used the injection of saline as a control for the injection of vasopressin or epinephrine. To date, no study has compared the use of vasopressin versus no injection in a controlled, randomized manner. We do not know if the injection of saline intracervically may actually increase the amount of bleeding over the baseline and therefore the decreased blood loss caused by the injection of vasopressin my actually be overestimated. We propose to compare the effects of injecting vasopressin intracervically preoperatively versus no preoperative medication. We will not only evaluate the amount of operative blood loss, but also compare operative time and complication rates.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 27, 2008
Enrollment StartJan 1, 2004
Primary CompletionJan 1, 2005
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 17.6 years ago

Interventions

Vasopressindrug

20cc of dilute vasopressin (20units in 50cc normal saline). At beginning of the procedure 5cc injected were injected at 2,4,8 and 10 o'clock on the cervix