Evaluating Efficacy of Intravenous Carbetocin Versus Intramyometrial Injection of Adrenaline in Reducing Blood Loss
Condition: Uterine Fibroid
MeSH terms: Leiomyoma
Study type: Interventional
Phase: Phase 1

Summary: 
      Uterine fibroids, affecting 20-50% of all women ,and are benign tumors that arise from
      myometrial cells of the uterine smooth muscle tissue. Although most are asymptomatic,
      fibroids can often cause abnormal uterine bleeding, iron deficiency anemia, pelvic pressure
      symptoms and pain
    

Detailed description: 
      Women with myomatous uteri have an increased number of blood supply which may cause excessive
      bleeding during myomectomy. The excessive bleeding may result in blood transfusions and
      prolonged hospital stays. A variety of methods are used to reduce bleeding during myomectomy
      including preoperative administration of gonadotropin-releasing hormone (GnRH) agonists,
      uterine artery tourniquet, vaginal misoprostol, intravenous tranexamic acid, intramyometrial
      injections of bupivacaine plus adrenaline and vasopressin, chemical dissection with Mesna
      (sodium-2-mercaptoethanesulfonate), perioperative injection of ascorbic acid, and, recently,
      carbetocin.

      Currently, there are several strategies for the treatment of fibroids. Still, myomectomy, the
      surgical removal of myomas, is an important treatment option for symptomatic leiomyomas,
      especially in women who wish to preserve their uteri.This can be accomplished via laparotomy,
      laparoscopy or hysteroscopy.

      Oxytocin is a hormone secreted from the posterior pituitary and exerts its effect on the
      uterus by producing uterine contractions during labor and delivery. Because of this
      contractile feature, synthetic oxytocin analogs are used in the treatment of postpartum
      uterine atony and hemorrhage. Based on its ability to attenuate blood loss, oxytocin has been
      evaluated in gynecologic procedures, including hysterectomies, myomectomies, and endometrial
      resections. Although the expression of oxytocin receptors is thought to be strictly related
      to pregnancy, their presence has been demonstrated in the leiomyomatous uterus.

      Carbetocin was first introduced to control postpartum hemorrhage, but its manageability and
      efficacy soon made it an interesting option for gynecologic surgeons. Given its longer
      half-life compared with oxytocin and its ample bioavailability, carbetocin could represent a
      very useful tool during myomectomy, administered either intravenously or intramuscularly
      Following promising reports on the effectiveness of carbetocin in reducing intraoperative
      blood loss, hemoglobin drop, and need for postoperative blood transfusions.

      Adrenaline is a potent vasoconstrictive agent that has a high risk of cardiovascular effects
      if an intravascular instillation is performed. The vasoconstrictive effect of adrenaline on
      tissue lasts longer than that of vasopressin.

      Bupivacaine is a local anesthetic that causes vasodilatation at clinical doses, but lower
      doses appear to cause vasoconstriction. Bupivacaine has shown to have a vasoconstrictive
      activity in concentrations of ≤ 0.25%, with duration of its action between 4 and 24 h when
      used for local infiltration. The use of a combination of bupivacaine and low dose of
      adrenaline in order to minimize the cardiovascular effects of the latest without interfering
      with the vasoconstrictive effects on haemostasis has been documented.

      The myometrial injection of adrenaline plus bupivacaine was one of the evaluated methods
      showing significantly reduced blood loss and shorter duration of surgery compared to placebo
    

Intervention name(s): Carbetocin
Intervention type(s): Drug
Intervention description(s): To compare efficacy of intravenous carbetocin to intramyometrial injection of adrenaline in decreasing intraoperative blood loss and need for blood transfusion during abdominal myomectomy.
Other intervention name(s): Adrenaline
Intervention MeSH terms: Carbetocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment