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

• Sponsor: Rutgers, The State University of New Jersey (Other)
• Overall Status: Completed
• CT.gov ID: NCT02959840
• Collaborator: (none)
• Enrollment: 180
• Location: 1
• Arms: 3
• Actual Duration (Months): 25.8
• Patients Per Site Per Month: 7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nausea; Vomiting; Satisfaction	Device: Acupressure Point P6 stimulator; Drug: Metoclopramide; Drug: Ondansetron	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 180 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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?
• Actual Study Start Date: Jul 1, 2015
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Aug 23, 2017

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia
Active Comparator: Metoclopramide, Ondansetron 10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia	Drug: Metoclopramide; 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia.; Other Names: Reglan ; Drug: Ondansetron; 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia.; Other Names: Zofran
Experimental: Acupressure Point P6 stimulator 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.	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.

Outcome Measures

Primary Outcome Measures

1. Nausea [During the surgical procedure]

   The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea at any point during the surgical procedure in each group.

2. Vomiting [During the surgical procedure]

   The investigators will perform objective assessments of whether or not the patients have vomited during the procedure. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group.

Secondary Outcome Measures

1. Nausea During Stage I (After the Administration of CSE and Until Eversion of the Uterus) [During the surgical procedure]

   Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) during stage I. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea.

2. Nausea During Stage II (After Eversion of the Uterus and Until Replacement of the Uterus) [During the surgical procedure]

   Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) during stage II. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea.

3. Nausea During Stage III (After Replacement of the Uterus and to the Next 15 Minutes) [During the surgical procedure]

   Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) during stage III. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea.

4. Nausea During Stage IV (the Rest of the Time Until Arrival at PACU) [During the surgical procedure]

   Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) during stage IV. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea.

5. Vomiting During Stage I (After the Administration of CSE and Until Eversion of the Uterus) [During the surgical procedure]

   The investigators will perform objective assessments of whether or not the patients have vomited during stage I. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group.

6. Vomiting During Stage II (After Eversion of the Uterus and Until Replacement of the Uterus) [During the surgical procedure]

   The investigators will perform objective assessments of whether or not the patients have vomited during stage II. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group.

7. Vomiting During Stage III (After Replacement of the Uterus and to the Next 15 Minutes) [During the surgical procedure]

   The investigators will perform objective assessments of whether or not the patients have vomited during stage III. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group.

8. Vomiting During Stage IV (the Rest of the Time Until Arrival at PACU) [During the surgical procedure]

   The investigators will perform objective assessments of whether or not the patients have vomited during stage IV. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group.

9. Satisfaction of Anti-emetic Treatment [During the surgical procedure]

   Patients are asked their anti-emetic treatment satisfaction (0 = Not Satisfied, 10 = Extremely Satisfied). Data are expressed as number of parturients who gave a score of 8 or higher.

10. Overall Anesthetic Care Satisfaction [During the surgical procedure]

    Patients are asked their overall anesthetic care satisfaction (0 = Not Satisfied, 10 = Extremely Satisfied). Data are expressed as number of parturients who gave a score of 8 or higher.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Robert Wood Johnson University Hospital	New Brunswick	New Jersey	United States	08901

Sponsors and Collaborators

• Rutgers, The State University of New Jersey

Investigators

• Principal Investigator: Shaul Cohen, MD, Robert Wood Johnson University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• Afolabi BB, Lesi FE. Regional versus general anaesthesia for caesarean section. Cochrane Database Syst Rev. 2012 Oct 17;10:CD004350. doi: 10.1002/14651858.CD004350.pub3. Review.
• Arnberger M, Stadelmann K, Alischer P, Ponert R, Melber A, Greif R. Monitoring of neuromuscular blockade at the P6 acupuncture point reduces the incidence of postoperative nausea and vomiting. Anesthesiology. 2007 Dec;107(6):903-8.
• Chen HM, Chang FY, Hsu CT. Effect of acupressure on nausea, vomiting, anxiety and pain among post-cesarean section women in Taiwan. Kaohsiung J Med Sci. 2005 Aug;21(8):341-50.
• Duggal KN, Douglas MJ, Peteru EA, Merrick PM. Acupressure for intrathecal narcotic-induced nausea and vomiting after caesarean section. Int J Obstet Anesth. 1998 Oct;7(4):231-6.
• Fan CF, Tanhui E, Joshi S, Trivedi S, Hong Y, Shevde K. Acupressure treatment for prevention of postoperative nausea and vomiting. Anesth Analg. 1997 Apr;84(4):821-5.
• Gan TJ, Jiao KR, Zenn M, Georgiade G. A randomized controlled comparison of electro-acupoint stimulation or ondansetron versus placebo for the prevention of postoperative nausea and vomiting. Anesth Analg. 2004 Oct;99(4):1070-1075. doi: 10.1213/01.ANE.0000130355.91214.9E.
• Golembiewski J, Chernin E, Chopra T. Prevention and treatment of postoperative nausea and vomiting. Am J Health Syst Pharm. 2005 Jun 15;62(12):1247-60; quiz 1261-2. Review.
• Habib AS, Itchon-Ramos N, Phillips-Bute BG, Gan TJ; Duke Women's Anesthesia (DWA) Research Group. Transcutaneous acupoint electrical stimulation with the ReliefBand for the prevention of nausea and vomiting during and after cesarean delivery under spinal anesthesia. Anesth Analg. 2006 Feb;102(2):581-4.
• Harmon D, Ryan M, Kelly A, Bowen M. Acupressure and prevention of nausea and vomiting during and after spinal anaesthesia for caesarean section. Br J Anaesth. 2000 Apr;84(4):463-7.
• Ho CM, Hseu SS, Tsai SK, Lee TY. Effect of P-6 acupressure on prevention of nausea and vomiting after epidural morphine for post-cesarean section pain relief. Acta Anaesthesiol Scand. 1996 Mar;40(3):372-5.
• Ho CM, Tsai HJ, Chan KH, Tsai SK. P6 acupressure does not prevent emesis during spinal anesthesia for cesarean delivery. Anesth Analg. 2006 Mar;102(3):900-3.
• Lewis IH, Pryn SJ, Reynolds PI, Pandit UA, Wilton NC. Effect of P6 acupressure on postoperative vomiting in children undergoing outpatient strabismus correction. Br J Anaesth. 1991 Jul;67(1):73-8.
• Stein DJ, Birnbach DJ, Danzer BI, Kuroda MM, Grunebaum A, Thys DM. Acupressure versus intravenous metoclopramide to prevent nausea and vomiting during spinal anesthesia for cesarean section. Anesth Analg. 1997 Feb;84(2):342-5.
• White PF, Issioui T, Hu J, Jones SB, Coleman JE, Waddle JP, Markowitz SD, Coloma M, Macaluso AR, Ing CH. Comparative efficacy of acustimulation (ReliefBand) versus ondansetron (Zofran) in combination with droperidol for preventing nausea and vomiting. Anesthesiology. 2002 Nov;97(5):1075-81.
• Zárate E, Mingus M, White PF, Chiu JW, Scuderi P, Loskota W, Daneshgari V. The use of transcutaneous acupoint electrical stimulation for preventing nausea and vomiting after laparoscopic surgery. Anesth Analg. 2001 Mar;92(3):629-35.

• Responsible Party: Shaul Cohen, M.D., Director of Obstetric Anesthesia, Rutgers, The State University of New Jersey
• ClinicalTrials.gov Identifier: NCT02959840
• Other Study ID Numbers: Pro20140000517
• First Posted: Nov 9, 2016
• Last Update Posted: Sep 25, 2017
• Last Verified: Aug 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Nausea; Vomiting; Ondansetron; Metoclopramide

Study Results

Participant Flow

Arm/Group Title	Control	Metoclopramide, Ondansetron	Acupressure Point P6 Stimulator
Arm/Group Description	No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia	10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia. Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia.	Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
Period Title: Overall Study
STARTED	60	60	60
COMPLETED	60	60	60
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Control	Metoclopramide, Ondansetron	Acupressure Point P6 Stimulator	Total
Arm/Group Description	No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia	10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia. Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia.	Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.	Total of all reporting groups
Overall Participants	60	60	60	180
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	60 100%	60 100%	60 100%	180 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	60 100%	60 100%	60 100%	180 100%
Male	0 0%	0 0%	0 0%	0 0%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	60 100%	60 100%	60 100%	180 100%

Outcome Measures

1. Primary Outcome

Title	Nausea
Description	The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea at any point during the surgical procedure in each group.
Time Frame	During the surgical procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Metoclopramide, Ondansetron	Acupressure Point P6 Stimulator
Arm/Group Description	No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia	10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia. Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia.	Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
Measure Participants	60	60	60
Count of Participants [Participants]	44 73.3%	14 23.3%	22 36.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, Metoclopramide, Ondansetron
	Comments
	Type of Statistical Test	Equivalence
	Comments	Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.
Statistical Test of Hypothesis	p-Value	< 0.00001
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Control, Acupressure Point P6 Stimulator
	Comments
	Type of Statistical Test	Equivalence
	Comments	Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.
Statistical Test of Hypothesis	p-Value	0.00005
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Metoclopramide, Ondansetron, Acupressure Point P6 Stimulator
	Comments
	Type of Statistical Test	Equivalence
	Comments	Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.
Statistical Test of Hypothesis	p-Value	0.1
	Comments
	Method	Chi-squared
	Comments

2. Primary Outcome

Title	Vomiting
Description	The investigators will perform objective assessments of whether or not the patients have vomited during the procedure. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group.
Time Frame	During the surgical procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Metoclopramide, Ondansetron	Acupressure Point P6 Stimulator
Arm/Group Description	No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia	10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia. Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia.	Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
Measure Participants	60	60	60
Count of Participants [Participants]	27 45%	10 16.7%	8 13.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, Metoclopramide, Ondansetron
	Comments
	Type of Statistical Test	Equivalence
	Comments	Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Control, Acupressure Point P6 Stimulator
	Comments
	Type of Statistical Test	Equivalence
	Comments	Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.
Statistical Test of Hypothesis	p-Value	0.0002
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Metoclopramide, Ondansetron, Acupressure Point P6 Stimulator
	Comments
	Type of Statistical Test	Equivalence
	Comments	Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.
Statistical Test of Hypothesis	p-Value	0.8
	Comments
	Method	Chi-squared
	Comments

3. Secondary Outcome

Title	Nausea During Stage I (After the Administration of CSE and Until Eversion of the Uterus)
Description	Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) during stage I. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea.
Time Frame	During the surgical procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Metoclopramide, Ondansetron	Acupressure Point P6 Stimulator
Arm/Group Description	No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia	10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia. Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia.	Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
Measure Participants	60	60	60
Count of Participants [Participants]	33 55%	7 11.7%	14 23.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, Metoclopramide, Ondansetron
	Comments
	Type of Statistical Test	Equivalence
	Comments	Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.
Statistical Test of Hypothesis	p-Value	0.00004
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Control, Acupressure Point P6 Stimulator
	Comments
	Type of Statistical Test	Equivalence
	Comments	Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.
Statistical Test of Hypothesis	p-Value	0.0004
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Metoclopramide, Ondansetron, Acupressure Point P6 Stimulator
	Comments
	Type of Statistical Test	Equivalence
	Comments	Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.
Statistical Test of Hypothesis	p-Value	0.09
	Comments
	Method	Chi-squared
	Comments

4. Secondary Outcome

Title	Nausea During Stage II (After Eversion of the Uterus and Until Replacement of the Uterus)
Description	Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) during stage II. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea.
Time Frame	During the surgical procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Metoclopramide, Ondansetron	Acupressure Point P6 Stimulator
Arm/Group Description	No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia	10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia. Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia.	Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
Measure Participants	60	60	60
Count of Participants [Participants]	12 20%	6 10%	5 8.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, Metoclopramide, Ondansetron
	Comments
	Type of Statistical Test	Equivalence
	Comments	Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.
Statistical Test of Hypothesis	p-Value	0.1
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Control, Acupressure Point P6 Stimulator
	Comments
	Type of Statistical Test	Equivalence
	Comments	Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.
Statistical Test of Hypothesis	p-Value	0.07
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Metoclopramide, Ondansetron, Acupressure Point P6 Stimulator
	Comments
	Type of Statistical Test	Equivalence
	Comments	Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.
Statistical Test of Hypothesis	p-Value	0.7
	Comments
	Method	Chi-squared
	Comments

5. Secondary Outcome

Title	Nausea During Stage III (After Replacement of the Uterus and to the Next 15 Minutes)
Description	Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) during stage III. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea.
Time Frame	During the surgical procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Metoclopramide, Ondansetron	Acupressure Point P6 Stimulator
Arm/Group Description	No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia	10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia. Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia.	Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
Measure Participants	60	60	60
Count of Participants [Participants]	16 26.7%	8 13.3%	14 23.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, Metoclopramide, Ondansetron
	Comments
	Type of Statistical Test	Equivalence
	Comments	Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.
Statistical Test of Hypothesis	p-Value	0.7
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Control, Acupressure Point P6 Stimulator
	Comments
	Type of Statistical Test	Equivalence
	Comments	Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.
Statistical Test of Hypothesis	p-Value	0.7
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Metoclopramide, Ondansetron, Acupressure Point P6 Stimulator
	Comments
	Type of Statistical Test	Equivalence
	Comments	Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.
Statistical Test of Hypothesis	p-Value	0.2
	Comments
	Method	Chi-squared
	Comments

6. Secondary Outcome

Title	Nausea During Stage IV (the Rest of the Time Until Arrival at PACU)
Description	Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) during stage IV. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea.
Time Frame	During the surgical procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Metoclopramide, Ondansetron	Acupressure Point P6 Stimulator
Arm/Group Description	No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia	10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia. Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia.	Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
Measure Participants	60	60	60
Count of Participants [Participants]	3 5%	4 6.7%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, Metoclopramide, Ondansetron
	Comments
	Type of Statistical Test	Equivalence
	Comments	Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.
Statistical Test of Hypothesis	p-Value	1
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Control, Acupressure Point P6 Stimulator
	Comments
	Type of Statistical Test	Equivalence
	Comments	Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.
Statistical Test of Hypothesis	p-Value	0.2
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Metoclopramide, Ondansetron, Acupressure Point P6 Stimulator
	Comments
	Type of Statistical Test	Equivalence
	Comments	Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.
Statistical Test of Hypothesis	p-Value	0.1
	Comments
	Method	Chi-squared
	Comments

7. Secondary Outcome

Title	Vomiting During Stage I (After the Administration of CSE and Until Eversion of the Uterus)
Description	The investigators will perform objective assessments of whether or not the patients have vomited during stage I. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group.
Time Frame	During the surgical procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Metoclopramide, Ondansetron	Acupressure Point P6 Stimulator
Arm/Group Description	No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia	10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia. Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia.	Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
Measure Participants	60	60	60
Count of Participants [Participants]	20 33.3%	5 8.3%	4 6.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, Metoclopramide, Ondansetron
	Comments
	Type of Statistical Test	Equivalence
	Comments	Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Control, Acupressure Point P6 Stimulator
	Comments
	Type of Statistical Test	Equivalence
	Comments	Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.
Statistical Test of Hypothesis	p-Value	0.0004
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Metoclopramide, Ondansetron, Acupressure Point P6 Stimulator
	Comments
	Type of Statistical Test	Equivalence
	Comments	Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.
Statistical Test of Hypothesis	p-Value	1
	Comments
	Method	Chi-squared
	Comments

8. Secondary Outcome

Title	Vomiting During Stage II (After Eversion of the Uterus and Until Replacement of the Uterus)
Description	The investigators will perform objective assessments of whether or not the patients have vomited during stage II. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group.
Time Frame	During the surgical procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Metoclopramide, Ondansetron	Acupressure Point P6 Stimulator
Arm/Group Description	No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia	10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia. Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia.	Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
Measure Participants	60	60	60
Count of Participants [Participants]	10 16.7%	1 1.7%	3 5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, Metoclopramide, Ondansetron
	Comments
	Type of Statistical Test	Equivalence
	Comments	Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.
Statistical Test of Hypothesis	p-Value	0.008
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Control, Acupressure Point P6 Stimulator
	Comments
	Type of Statistical Test	Equivalence
	Comments	Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.
Statistical Test of Hypothesis	p-Value	0.07
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Metoclopramide, Ondansetron, Acupressure Point P6 Stimulator
	Comments
	Type of Statistical Test	Equivalence
	Comments	Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.
Statistical Test of Hypothesis	p-Value	0.6
	Comments
	Method	Chi-squared
	Comments

9. Secondary Outcome

Title	Vomiting During Stage III (After Replacement of the Uterus and to the Next 15 Minutes)
Description	The investigators will perform objective assessments of whether or not the patients have vomited during stage III. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group.
Time Frame	During the surgical procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Metoclopramide, Ondansetron	Acupressure Point P6 Stimulator
Arm/Group Description	No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia	10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia. Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia.	Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
Measure Participants	60	60	60
Count of Participants [Participants]	9 15%	4 6.7%	6 10%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, Metoclopramide, Ondansetron
	Comments
	Type of Statistical Test	Equivalence
	Comments	Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.
Statistical Test of Hypothesis	p-Value	0.2
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Control, Acupressure Point P6 Stimulator
	Comments
	Type of Statistical Test	Equivalence
	Comments	Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.
Statistical Test of Hypothesis	p-Value	0.5
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Metoclopramide, Ondansetron, Acupressure Point P6 Stimulator
	Comments
	Type of Statistical Test	Equivalence
	Comments	Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.
Statistical Test of Hypothesis	p-Value	0.7
	Comments
	Method	Chi-squared
	Comments

10. Secondary Outcome

Title	Vomiting During Stage IV (the Rest of the Time Until Arrival at PACU)
Description	The investigators will perform objective assessments of whether or not the patients have vomited during stage IV. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group.
Time Frame	During the surgical procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Metoclopramide, Ondansetron	Acupressure Point P6 Stimulator
Arm/Group Description	No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia	10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia. Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia.	Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
Measure Participants	60	60	60
Count of Participants [Participants]	0 0%	2 3.3%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, Metoclopramide, Ondansetron
	Comments
	Type of Statistical Test	Equivalence
	Comments	Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.
Statistical Test of Hypothesis	p-Value	0.5
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Control, Acupressure Point P6 Stimulator
	Comments
	Type of Statistical Test	Equivalence
	Comments	Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.
Statistical Test of Hypothesis	p-Value	1
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Metoclopramide, Ondansetron, Acupressure Point P6 Stimulator
	Comments
	Type of Statistical Test	Equivalence
	Comments	Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.
Statistical Test of Hypothesis	p-Value	0.5
	Comments
	Method	Chi-squared
	Comments

11. Secondary Outcome

Title	Satisfaction of Anti-emetic Treatment
Description	Patients are asked their anti-emetic treatment satisfaction (0 = Not Satisfied, 10 = Extremely Satisfied). Data are expressed as number of parturients who gave a score of 8 or higher.
Time Frame	During the surgical procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Metoclopramide, Ondansetron	Acupressure Point P6 Stimulator
Arm/Group Description	No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia	10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia. Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia.	Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
Measure Participants	60	60	60
Count of Participants [Participants]	49 81.7%	58 96.7%	55 91.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, Metoclopramide, Ondansetron
	Comments
	Type of Statistical Test	Superiority
	Comments	Our null hypothesis is that there is no statistically significant difference between the mean satisfaction level in the above 2 groups.
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	Fisher Exact
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Control, Acupressure Point P6 Stimulator
	Comments
	Type of Statistical Test	Equivalence
	Comments	Our null hypothesis is that there is no statistically significant difference between the mean satisfaction level in the above 2 groups.
Statistical Test of Hypothesis	p-Value	0.2
	Comments
	Method	Fisher Exact
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Metoclopramide, Ondansetron, Acupressure Point P6 Stimulator
	Comments
	Type of Statistical Test	Equivalence
	Comments	Our null hypothesis is that there is no statistically significant difference between the mean satisfaction level in the above 2 groups.
Statistical Test of Hypothesis	p-Value	0.3
	Comments
	Method	Fisher Exact
	Comments

12. Secondary Outcome

Title	Overall Anesthetic Care Satisfaction
Description	Patients are asked their overall anesthetic care satisfaction (0 = Not Satisfied, 10 = Extremely Satisfied). Data are expressed as number of parturients who gave a score of 8 or higher.
Time Frame	During the surgical procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Metoclopramide, Ondansetron	Acupressure Point P6 Stimulator
Arm/Group Description	No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia	10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia. Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia.	Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
Measure Participants	60	60	60
Count of Participants [Participants]	53 88.3%	58 96.7%	56 93.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, Metoclopramide, Ondansetron
	Comments
	Type of Statistical Test	Equivalence
	Comments	Our null hypothesis is that there is no statistically significant difference between the mean satisfaction level in the above 2 groups.
Statistical Test of Hypothesis	p-Value	0.2
	Comments
	Method	Fisher Exact
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Control, Acupressure Point P6 Stimulator
	Comments
	Type of Statistical Test	Equivalence
	Comments	Our null hypothesis is that there is no statistically significant difference between the mean satisfaction level in the above 2 groups.
Statistical Test of Hypothesis	p-Value	0.5
	Comments
	Method	Fisher Exact
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Metoclopramide, Ondansetron, Acupressure Point P6 Stimulator
	Comments
	Type of Statistical Test	Equivalence
	Comments	Our null hypothesis is that there is no statistically significant difference between the mean satisfaction level in the above 2 groups.
Statistical Test of Hypothesis	p-Value	0.7
	Comments
	Method	Fisher Exact
	Comments

Adverse Events

Arm/Group Title	Control		Metoclopramide, Ondansetron		Acupressure Point P6 Stimulator
Arm/Group Description	No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia		10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia. Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia.		Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete.
All Cause Mortality
	Control		Metoclopramide, Ondansetron		Acupressure Point P6 Stimulator
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/60 (0%)		0/60 (0%)
Serious Adverse Events
	Control		Metoclopramide, Ondansetron		Acupressure Point P6 Stimulator
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/60 (0%)		0/60 (0%)
Other (Not Including Serious) Adverse Events
	Control		Metoclopramide, Ondansetron		Acupressure Point P6 Stimulator
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/60 (0%)		0/60 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.