NCT02959840

Acupuncture Point P6 Stimulation for Reduction of Nausea and Vomiting During Cesarean

Is Intra-operative Acupuncture Point P6 Stimulation as Effective as Traditional Pharmacotherapy in Reducing Nausea and Vomiting During Cesarean Section With Regional Anesthesia?

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Nausea
• Vomiting
• Satisfaction

Interventions

Type	Name	Description
DEVICE	Acupressure Point P6 stimulator	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.
DRUG	Metoclopramide	10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia.
DRUG	Ondansetron	8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia.

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-03-01
• Completion: 2017-08-23
• First posted: 2016-11-09
• Last updated: 2017-09-25
• Results posted: 2017-07-25

Locations

1 site across 1 country: United States