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Comparison of the Effects of Cervical Vasopressin Versus no Premedication on Blood Loss During Vaginal Hysterectomy: A Randomized, Placebo Controlled Trial

NCT00799292 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2018-07-24

Study results available
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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.

Conditions

  • Blood Loss During Vaginal Hysterectomy

Interventions

DRUG

Vasopressin

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

Sponsors & Collaborators

  • Ascher-Walsh, Charles, M.D.

    lead INDIV

Principal Investigators

  • Charles Ascher-Walsh, MD, MPH · Mt Sinai School of Medicine, Dept Obstetrics and Gynecology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2005-01-31
Completion
2005-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00799292 on ClinicalTrials.gov