Efficacy of Ginger on Intraoperative and Postoperative Nausea and Vomiting in Elective Cesarean Section Patients
Condition: Nausea; Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      SPECIFIC AIMS

        -  Assess risk factors for nausea and vomiting in c-section patients undergoing regional
           anesthesia

        -  Quantify the incidence of nausea and vomiting intraoperatively and postoperatively in
           the ginger and placebo groups.

        -  Quantify post-operative analgesia and pruritus in the ginger and placebo groups

        -  Quantify patient satisfaction of the ginger and placebo groups

        -  Assess patient expectation of ginger on post-op day three
    

Detailed description: 
      Two hundred and thirty nine ASA class I and II patients, scheduled for elective c-section
      will be assigned randomly to receive either 1g ginger tablet PO (Group 1) or 1 g placebo PO
      (Group 2) preoperatively, immediately before surgery. The usual preoperative anti-emetic and
      antacid regimen will be continued for both groups. Initial blood pressure, pulse and
      hemoglobin and hematocrit will be documented by the researcher prior to the arrival of the
      patient into the operating room. A baseline questionnaire will be given to the patients to
      assess risk factors for nausea and vomiting. Questions will include: age, BMI, parity, weeks
      gestation, h/o seasickness, h/o of hyperemesis gravidrum in this or prior pregnancies, h/o
      PONV, medical problems, any medication used within past 24 hrs, education and occupation.

      Intraoperatively, both groups will receive combined spinal-epidural anesthesia in the usual
      manner. All standard monitoring will be applied and vital signs recorded for the entirety of
      the procedure. The number and dose of ephedrine or phenylephrine boluses and the number and
      severity of nausea episodes (using a Visual Analog Scale (VANS)) and number of vomiting
      episodes will be noted. In addition the following will be recorded: if uterus was
      exteriorized, any medications used by the anesthesiologist (other than ephedrine and
      phenylephrine), and estimated blood loss.

      Postoperatively, patients will receive either a one time dose of the 1g ginger PO (Group 1)
      or 1 g placebo PO (Group 2) 2 hours after entering the postanesthesia care unit (PACU).
      Thirty minutes after the medication is given, patients will be asked to rate their nausea,
      level of analgesia, and level of pruritus on a VANS, and vomiting episodes will be recorded.
      Medications given for nausea will be continued in the post-operative period for both groups.
      The doses of Zofran will be counted in the 24 hr postoperative period. Twenty-four hours
      after surgery, blood will be drawn to assess hemoglobin and hematocrit as well as to assess
      platelet function.
    

Intervention name(s): Ginger; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Ginger is an herb. The rhizome (underground stem) is used as a spice and also as a medicine. It can be used fresh, dried and powdered, or as a juice or oil. Two capsules (1g each) of dry powdered ginger are given, one capsule a half-hour before induction of anesthesia and the second 2h after surgery.; Two capsules (1g each) of placebo, one capsule a half-hour before induction of anesthesia and the second 2h after surgery.
Other intervention name(s): Zingiber Officinale
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Nausea; Vomiting; Cesaraen; Ginger; cesarean section