Comparison of the Effects of Cervical Vasopressin Versus no Premedication on Blood Loss During Vaginal Hysterectomy: A Randomized, Placebo Controlled Trial
Condition: Blood Loss During Vaginal Hysterectomy
MeSH terms: Hemorrhage
Intervention: Vasopressin
Intervention description: 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
Intervention MeSH terms: Vasopressins; Arginine Vasopressin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 58.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  women greater that 18 undergoing vaginal hysterectomy for any indication, with or
             without concomitant procedures

        Exclusion Criteria:

          -  women with a significant medical condition, including severe liver disease, congestive
             heart failure, documented coronary artery disease, impaired renal function determined
             by an elevated serum creatinine, asthma with steroid use in the past year, and
             migraines