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CompletedNCT02959840Updated Sep 25, 2017Results posted

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

A Phase 4 interventional study of Acupressure Point P6 stimulator and Metoclopramide in Nausea, Vomiting and Satisfaction, sponsored by Rutgers, The State University of New Jersey. Completed at 1 site in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-25.

Sponsored by Rutgers, The State University of New Jersey · Phase 4, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Jul 2015, registered Oct 2016).
Phase
Phase 4
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Nausea
  • Vomiting
  • Satisfaction

Browse trials for

03

In context

Nausea

822 studies on the registry are indexed under Nausea; 104 are open to participants now.

This study's enrollment of 180 is above the median of 115 across 703 interventional studies indexed under Nausea.

Browse Nausea studies →

Lead sponsor

Rutgers, The State University of New Jersey is the lead sponsor of 496 studies on the registry; 130 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 30 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
180 participants (actual)

Study arms

  • 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 · Drug: Ondansetron

  • 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

Interventions

  • DeviceAcupressure 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.

  • DrugMetoclopramide

    10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia.

    Also known as: Reglan

  • DrugOndansetron

    8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia.

    Also known as: Zofran

06

What researchers measure

Primary outcomes

  1. Nausea

    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

  2. Vomiting

    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

Secondary outcomes

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

    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

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

    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

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

    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

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

    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

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

    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

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

    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

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

    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

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

    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

  9. Satisfaction of Anti-emetic Treatment

    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

  10. Overall Anesthetic Care Satisfaction

    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

07

Results

Posted Jul 25, 2017

Participant flow

Participant flow — Overall Study
MilestoneControlMetoclopramide, OndansetronAcupressure Point P6 Stimulator
Started606060
Completed606060
Not completed000

Outcome measures

PrimaryNausea

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
Reported as:
Count of participants · Participants
Nausea
ParticipantsControlMetoclopramide, OndansetronAcupressure Point P6 Stimulator
Nausea441422
Statistical analysis
  • Control vs Metoclopramide, Ondansetron · Chi-squared · p = < 0.00001
  • Control vs Acupressure Point P6 Stimulator · Chi-squared · p = 0.00005
  • Metoclopramide, Ondansetron vs Acupressure Point P6 Stimulator · Chi-squared · p = 0.1
PrimaryVomiting

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
Reported as:
Count of participants · Participants
Vomiting
ParticipantsControlMetoclopramide, OndansetronAcupressure Point P6 Stimulator
Vomiting27108
Statistical analysis
  • Control vs Metoclopramide, Ondansetron · Chi-squared · p = 0.001
  • Control vs Acupressure Point P6 Stimulator · Chi-squared · p = 0.0002
  • Metoclopramide, Ondansetron vs Acupressure Point P6 Stimulator · Chi-squared · p = 0.8
SecondaryNausea During Stage I (After the Administration of CSE and Until Eversion of the Uterus)

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
Reported as:
Count of participants · Participants
Nausea During Stage I (After the Administration of CSE and Until Eversion of the Uterus)
ParticipantsControlMetoclopramide, OndansetronAcupressure Point P6 Stimulator
Nausea During Stage I (After the Administration of CSE and Until Eversion of the Uterus)33714
Statistical analysis
  • Control vs Metoclopramide, Ondansetron · Chi-squared · p = 0.00004
  • Control vs Acupressure Point P6 Stimulator · Chi-squared · p = 0.0004
  • Metoclopramide, Ondansetron vs Acupressure Point P6 Stimulator · Chi-squared · p = 0.09
SecondaryNausea During Stage II (After Eversion of the Uterus and Until Replacement of the Uterus)

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
Reported as:
Count of participants · Participants
Nausea During Stage II (After Eversion of the Uterus and Until Replacement of the Uterus)
ParticipantsControlMetoclopramide, OndansetronAcupressure Point P6 Stimulator
Nausea During Stage II (After Eversion of the Uterus and Until Replacement of the Uterus)1265
Statistical analysis
  • Control vs Metoclopramide, Ondansetron · Chi-squared · p = 0.1
  • Control vs Acupressure Point P6 Stimulator · Chi-squared · p = 0.07
  • Metoclopramide, Ondansetron vs Acupressure Point P6 Stimulator · Chi-squared · p = 0.7
SecondaryNausea During Stage III (After Replacement of the Uterus and to the Next 15 Minutes)

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
Reported as:
Count of participants · Participants
Nausea During Stage III (After Replacement of the Uterus and to the Next 15 Minutes)
ParticipantsControlMetoclopramide, OndansetronAcupressure Point P6 Stimulator
Nausea During Stage III (After Replacement of the Uterus and to the Next 15 Minutes)16814
Statistical analysis
  • Control vs Metoclopramide, Ondansetron · Chi-squared · p = 0.7
  • Control vs Acupressure Point P6 Stimulator · Chi-squared · p = 0.7
  • Metoclopramide, Ondansetron vs Acupressure Point P6 Stimulator · Chi-squared · p = 0.2
SecondaryNausea During Stage IV (the Rest of the Time Until Arrival at PACU)

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
Reported as:
Count of participants · Participants
Nausea During Stage IV (the Rest of the Time Until Arrival at PACU)
ParticipantsControlMetoclopramide, OndansetronAcupressure Point P6 Stimulator
Nausea During Stage IV (the Rest of the Time Until Arrival at PACU)340
Statistical analysis
  • Control vs Metoclopramide, Ondansetron · Chi-squared · p = 1
  • Control vs Acupressure Point P6 Stimulator · Chi-squared · p = 0.2
  • Metoclopramide, Ondansetron vs Acupressure Point P6 Stimulator · Chi-squared · p = 0.1
SecondaryVomiting During Stage I (After the Administration of CSE and Until Eversion of the Uterus)

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
Reported as:
Count of participants · Participants
Vomiting During Stage I (After the Administration of CSE and Until Eversion of the Uterus)
ParticipantsControlMetoclopramide, OndansetronAcupressure Point P6 Stimulator
Vomiting During Stage I (After the Administration of CSE and Until Eversion of the Uterus)2054
Statistical analysis
  • Control vs Metoclopramide, Ondansetron · Chi-squared · p = 0.001
  • Control vs Acupressure Point P6 Stimulator · Chi-squared · p = 0.0004
  • Metoclopramide, Ondansetron vs Acupressure Point P6 Stimulator · Chi-squared · p = 1
SecondaryVomiting During Stage II (After Eversion of the Uterus and Until Replacement of the Uterus)

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
Reported as:
Count of participants · Participants
Vomiting During Stage II (After Eversion of the Uterus and Until Replacement of the Uterus)
ParticipantsControlMetoclopramide, OndansetronAcupressure Point P6 Stimulator
Vomiting During Stage II (After Eversion of the Uterus and Until Replacement of the Uterus)1013
Statistical analysis
  • Control vs Metoclopramide, Ondansetron · Chi-squared · p = 0.008
  • Control vs Acupressure Point P6 Stimulator · Chi-squared · p = 0.07
  • Metoclopramide, Ondansetron vs Acupressure Point P6 Stimulator · Chi-squared · p = 0.6
SecondaryVomiting During Stage III (After Replacement of the Uterus and to the Next 15 Minutes)

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
Reported as:
Count of participants · Participants
Vomiting During Stage III (After Replacement of the Uterus and to the Next 15 Minutes)
ParticipantsControlMetoclopramide, OndansetronAcupressure Point P6 Stimulator
Vomiting During Stage III (After Replacement of the Uterus and to the Next 15 Minutes)946
Statistical analysis
  • Control vs Metoclopramide, Ondansetron · Chi-squared · p = 0.2
  • Control vs Acupressure Point P6 Stimulator · Chi-squared · p = 0.5
  • Metoclopramide, Ondansetron vs Acupressure Point P6 Stimulator · Chi-squared · p = 0.7
SecondaryVomiting During Stage IV (the Rest of the Time Until Arrival at PACU)

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
Reported as:
Count of participants · Participants
Vomiting During Stage IV (the Rest of the Time Until Arrival at PACU)
ParticipantsControlMetoclopramide, OndansetronAcupressure Point P6 Stimulator
Vomiting During Stage IV (the Rest of the Time Until Arrival at PACU)020
Statistical analysis
  • Control vs Metoclopramide, Ondansetron · Chi-squared · p = 0.5
  • Control vs Acupressure Point P6 Stimulator · Chi-squared · p = 1
  • Metoclopramide, Ondansetron vs Acupressure Point P6 Stimulator · Chi-squared · p = 0.5
SecondarySatisfaction of Anti-emetic Treatment

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
Reported as:
Count of participants · Participants
Satisfaction of Anti-emetic Treatment
ParticipantsControlMetoclopramide, OndansetronAcupressure Point P6 Stimulator
Satisfaction of Anti-emetic Treatment495855
Statistical analysis
  • Control vs Metoclopramide, Ondansetron · Fisher Exact · p = 0.02
  • Control vs Acupressure Point P6 Stimulator · Fisher Exact · p = 0.2
  • Metoclopramide, Ondansetron vs Acupressure Point P6 Stimulator · Fisher Exact · p = 0.3
SecondaryOverall Anesthetic Care Satisfaction

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
Reported as:
Count of participants · Participants
Overall Anesthetic Care Satisfaction
ParticipantsControlMetoclopramide, OndansetronAcupressure Point P6 Stimulator
Overall Anesthetic Care Satisfaction535856
Statistical analysis
  • Control vs Metoclopramide, Ondansetron · Fisher Exact · p = 0.2
  • Control vs Acupressure Point P6 Stimulator · Fisher Exact · p = 0.5
  • Metoclopramide, Ondansetron vs Acupressure Point P6 Stimulator · Fisher Exact · p = 0.7

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Control0/60 (0%)0/60 (0%)0/60 (0%)
Metoclopramide, Ondansetron0/60 (0%)0/60 (0%)0/60 (0%)
Acupressure Point P6 Stimulator0/60 (0%)0/60 (0%)0/60 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)ControlMetoclopramide, OndansetronAcupressure Point P6 StimulatorTotal
<=18 years0000
Between 18 and 65 years606060180
>=65 years0000
Sex: Female, Male
Sex: Female, Male(Participants)ControlMetoclopramide, OndansetronAcupressure Point P6 StimulatorTotal
Female606060180
Male0000
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)ControlMetoclopramide, OndansetronAcupressure Point P6 StimulatorTotal
Count of participants———0
Region of Enrollment
Region of Enrollment(participants)ControlMetoclopramide, OndansetronAcupressure Point P6 StimulatorTotal
United States606060180
08

Study locations

1 site
  • Robert Wood Johnson University Hospital
    New Brunswick, New Jersey 08901, United States
09

References and documents

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. PubMed 23076903 ↗
  • 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. doi: 10.1097/01.anes.0000290617.98058.d9. PubMed 18043058 ↗
  • 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. doi: 10.1016/S1607-551X(09)70132-9. PubMed 16158876 ↗
  • 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. doi: 10.1016/s0959-289x(98)80044-7. PubMed 15321185 ↗
  • 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. doi: 10.1097/00000539-199704000-00023. PubMed 9085965 ↗
  • 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. PubMed 15385352 ↗
  • 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. doi: 10.1093/ajhp/62.12.1247. PubMed 15947124 ↗
  • 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. doi: 10.1213/01.ane.0000189217.19600.5c. PubMed 16428565 ↗
  • 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. doi: 10.1093/oxfordjournals.bja.a013471. PubMed 10823097 ↗
  • 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. doi: 10.1111/j.1399-6576.1996.tb04448.x. PubMed 8721471 ↗
  • 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. doi: 10.1213/01.ane.0000195553.82409.00. PubMed 16492848 ↗
  • 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. doi: 10.1093/bja/67.1.73. PubMed 1859764 ↗
  • 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. doi: 10.1097/00000539-199702000-00018. PubMed 9024025 ↗
  • 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. doi: 10.1097/00000542-200211000-00008. PubMed 12411789 ↗
  • Zarate 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. doi: 10.1097/00000539-200103000-00014. PubMed 11226090 ↗
  • Griffiths JD, Gyte GM, Popham PA, Williams K, Paranjothy S, Broughton HK, Brown HC, Thomas J. Interventions for preventing nausea and vomiting in women undergoing regional anaesthesia for caesarean section. Cochrane Database Syst Rev. 2021 May 18;5(5):CD007579. doi: 10.1002/14651858.CD007579.pub3. PubMed 34002866 ↗

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02959840
Lead sponsor
Rutgers, The State University of New Jersey
Responsible party
Shaul Cohen, M.D. (Director of Obstetric Anesthesia, Rutgers, The State University of New Jersey) — Principal investigator
First posted
Nov 9, 2016
Start date
Jul 2015
Primary completion
Mar 2016
Completion
Aug 23, 2017
Results posted
Jul 25, 2017
Last update
Sep 25, 2017

Study contacts

Shaul Cohen, MD
principal investigator · Robert Wood Johnson University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

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Rutgers, The State University of New Jersey

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