Clinical trial NCT02959840: Acupuncture Point P6 Stimulation for Reduction of Nausea and Vomiting During Cesarean
Official title: Is Intra-operative Acupuncture Point P6 Stimulation as Effective as Traditional Pharmacotherapy in Reducing Nausea and Vomiting During Cesarean Section With Regional Anesthesia?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nausea
Vomiting
Satisfaction
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2016-11-09
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Female subjects ages 18 to 45
2. Subjects with American Society of Anesthesiologists (ASA) Class I or II
3. Subjects with elective primary or repeat cesarean delivery
4. Subjects who receive combined spinal epidural anesthesia
5. English and non-English speaking subjects will be included in the study

Exclusion Criteria:

1. Female subjects \<18 years of age
2. Subjects requiring emergent cesarean delivery
3. History of placenta accrete
4. Multiple gestation pregnancy
5. ASA status III or higher
6. Current history of pregnancy induced hypertension, pre-eclampsia, or eclampsia
7. History of any chronic medication use (other than prenatal vitamins), including inhaler medications
8. Current urinary tract infection, pneumonia, or otitis media

Primary outcomes:
measure: Nausea
timeFrame: During the surgical procedure
measure: Vomiting
timeFrame: During the surgical procedure
Secondary outcomes:
measure: Nausea During Stage I (After the Administration of CSE and Until Eversion of the Uterus)
timeFrame: During the surgical procedure
measure: Nausea During Stage II (After Eversion of the Uterus and Until Replacement of the Uterus)
timeFrame: During the surgical procedure
measure: Nausea During Stage III (After Replacement of the Uterus and to the Next 15 Minutes)
timeFrame: During the surgical procedure
measure: Nausea During Stage IV (the Rest of the Time Until Arrival at PACU)
timeFrame: During the surgical procedure
measure: Vomiting During Stage I (After the Administration of CSE and Until Eversion of the Uterus)
timeFrame: During the surgical procedure
measure: Vomiting During Stage II (After Eversion of the Uterus and Until Replacement of the Uterus)
timeFrame: During the surgical procedure
measure: Vomiting During Stage III (After Replacement of the Uterus and to the Next 15 Minutes)
timeFrame: During the surgical procedure
measure: Vomiting During Stage IV (the Rest of the Time Until Arrival at PACU)
timeFrame: During the surgical procedure
measure: Satisfaction of Anti-emetic Treatment
timeFrame: During the surgical procedure
measure: Overall Anesthetic Care Satisfaction
timeFrame: During the surgical procedure
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Robert Wood Johnson University Hospital
state: New Jersey
Study officials:
affiliation: Robert Wood Johnson University Hospital
name: Shaul Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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