Acupuncture Point P6 Stimulation for Reduction of Nausea and Vomiting During Cesarean
Condition: Nausea; Vomiting; Satisfaction
MeSH terms: Nausea; Vomiting
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the effectiveness of acupressure point P6 stimulation
      versus intravenous ondansetron plus metoclopramide versus no antiemetic prophylaxis during
      elective cesarean section under regional anesthesia.
    

Detailed description: 
      The design of the study consists of the randomization of subjects undergoing cesarean section
      with regional anesthesia in one of three groups. The study is not blinded; as the
      participants will know which method they are being treated with because of the difference in
      site and nature of the acupuncture point P6 stimulation. The randomization of patients will
      be done by a computer to avoid bias before the informed consent form (ICF) is signed by the
      patients. The computer will generate three sets of random numbers for the three groups. Once
      the consent form is signed, the investigator will allocate the patients serially to the
      groups having those numbers . The randomization will be created before the study begins and
      will assign 180 subjects into one of the three groups to receive the treatment as follows:

      Group I (n=60): Will be the control group patients and will not be given traditional medical
      therapy nor will receive acupuncture point P6 stimulation prior to administration of the
      standardized epidural anesthesia, as outlined below.

      Group II (n=60): Will receive traditional medical management, consisting of 10 mg
      metoclopramide IV and 8 mg of ondansetron IV immediately prior to administration of the
      standardized regional anesthesia, as outlined below.

      Group III (n=60): Will receive acupuncture point P6 stimulation. This is a stimulation of the
      chi channel at the master of the heart (MH8 position) at the small depression of the volar
      surface of the distal right forearm just above the crest of the wrist. The device will be put
      on the patients in the operating room prior to administration of the regional anesthesia and
      will be removed after the cesarean section is complete. The device will be removed from the
      patient in the operating room, before the patient is transported to the recovery room.
      Patients will receive continuous stimulation at a level that is comfortable for the patient
      prior to administration of the standardized regional anesthesia, as outlined below.

      After the subjects have been randomly assigned to one of the three groups, subjects will
      receive the standardized regional anesthesia consisting of 2 milliliters (10 milligrams) of
      0.5% bupivicaine and 20 micrograms of fentanyl and 100 micrograms of epinephrine. Patients
      will offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no
      nausea, 10 = worst nausea every experienced).

      An Apfel score, which is used to predict the risk of experiencing post-operative nausea and
      vomiting (PONV), will also be determined with each subject.
    

Intervention name(s): Acupressure Point P6 stimulator; Metoclopramide; Ondansetron
Intervention type(s): Device; Drug; Drug
Intervention description(s): This device stimulates the chi channel at the master of the heart (MH8 position) at the small depression of the volar surface of the distal right forearm just above the crest of the wrist. The device is placed on patients in the operating room prior to administration of the regional anesthesia and will be removed after the cesarean section is complete. The device is removed from the patient in the operating room, before the patient is transported to the recovery room. Patients receive continuous stimulation at a level that is comfortable for the patient prior to administration of the standardized regional anesthesia.; 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia.; 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia.
Other intervention name(s): Reglan; Zofran
Intervention MeSH terms: Ondansetron; Metoclopramide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention