NauseaPhase 4NCT02959840
Acupuncture Point P6 Stimulation for Reduction of Nausea and Vomiting During Cesarean
A Phase 4 study testing Acupressure Point P6 stimulator, Metoclopramide and Ondansetron in people with Nausea and Vomiting, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nausea, Vomiting, Satisfaction
- What is being tested?
- Acupressure Point P6 stimulator, Metoclopramide and Ondansetron
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 23 Aug 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female subjects ages 18 to 45
- Subjects with American Society of Anesthesiologists (ASA) Class I or II
- Subjects with elective primary or repeat cesarean delivery
- Subjects who receive combined spinal epidural anesthesia
- English and non-English speaking subjects will be included in the study
Who cannot join
- Female subjects <18 years of age
- Subjects requiring emergent cesarean delivery
- History of placenta accrete
- Multiple gestation pregnancy
- ASA status III or higher
- Current history of pregnancy induced hypertension, pre-eclampsia, or eclampsia
- History of any chronic medication use (other than prenatal vitamins), including inhaler medications
- Current urinary tract infection, pneumonia, or otitis media
Trial locations and contacts
1 site in 1 country.
United States1 site
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901
About this study
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?
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.
- Conditions
- Nausea, Vomiting, Satisfaction
- Being tested
- Acupressure Point P6 stimulator, Metoclopramide, Ondansetron
- Medical subject headings
- Nausea, Vomiting, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupressure Point P6 stimulatorDevice
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.
MetoclopramideDrug
Also called Reglan
10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia.
OndansetronDrug
Also called Zofran
8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia |
| Metoclopramide, Ondansetron | Active comparator | 10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia Receives: Drug: Metoclopramide; Drug: Ondansetron |
| Acupressure Point P6 stimulator | Experimental | 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. Receives: Device: Acupressure Point P6 stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the surgical procedure
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.
Measured: During the surgical procedure
Secondary outcomes (10)
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.
Measured: During the surgical procedure
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.
Measured: During the surgical procedure
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.
Measured: During the surgical procedure
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.
Measured: During the surgical procedure
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.
Measured: During the surgical procedure
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.
Measured: During the surgical procedure
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.
Measured: During the surgical procedure
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.
Measured: During the surgical procedure
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.
Measured: During the surgical procedure
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.
Measured: During the surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study startJul 2015
- Primary completionMar 2016
- Study completion23 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for NauseaStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaul Cohen, M.D., Rutgers, The State University of New Jersey
- Investigators
- Shaul Cohen, MD, Principal investigator, Robert Wood Johnson University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02959840
- Sponsor's protocol ID
- Pro20140000517
- Status last verified
- Aug 2017
- First submitted
- 10 Oct 2016
- Last updated
- 25 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Afolabi BB, Lesi FE. Regional versus general anaesthesia for caesarean section. Cochrane Database Syst Rev. 2012 Oct 17;10(10):CD004350. doi: 10.1002/14651858.CD004350.pub3.
PubMed 23076903Arnberger 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 18043058Chen 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 16158876Duggal 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 15321185Fan 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 9085965Gan 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 15385352Golembiewski 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 15947124Habib 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 16428565Harmon 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 10823097Ho 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 8721471Ho 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 16492848Lewis 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 1859764Stein 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 9024025White 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 12411789Zarate 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT02959840
- Acronym / sponsor ID
- Pro20140000517
- Conditions
- Nausea, Vomiting, Satisfaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- 23 Aug 2017 (actual)
- First posted
- 9 Nov 2016 (estimated)
- Results
- Posted 25 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia |
| Metoclopramide, Ondansetron | Active comparator | Drug: Metoclopramide, Drug: Ondansetron10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia |
| Acupressure Point P6 stimulator | Experimental | Device: Acupressure Point P6 stimulatorAcupuncture 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female subjects ages 18 to 45
- Subjects with American Society of Anesthesiologists (ASA) Class I or II
- Subjects with elective primary or repeat cesarean delivery
- Subjects who receive combined spinal epidural anesthesia
- English and non-English speaking subjects will be included in the study
Key exclusion criteria (8 listed)
- Female subjects <18 years of age
- Subjects requiring emergent cesarean delivery
- History of placenta accrete
- Multiple gestation pregnancy
- ASA status III or higher
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupressure Point P6 stimulatorThis 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. | Device | Acupressure Point P6 stimulator |
| MetoclopramideAlso: Reglan10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia. | Drug | Metoclopramide, Ondansetron |
| OndansetronAlso: Zofran8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia. | Drug | Metoclopramide, Ondansetron |
Primary outcome
Nausea
Time frame: 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.
Vomiting
Time frame: 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.
10 secondary outcomes
Nausea During Stage I (After the Administration of CSE and Until Eversion of the Uterus)
Time frame: During the surgical procedure
Nausea During Stage II (After Eversion of the Uterus and Until Replacement of the Uterus)
Time frame: During the surgical procedure
Nausea During Stage III (After Replacement of the Uterus and to the Next 15 Minutes)
Time frame: During the surgical procedure
Nausea During Stage IV (the Rest of the Time Until Arrival at PACU)
Time frame: During the surgical procedure
Vomiting During Stage I (After the Administration of CSE and Until Eversion of the Uterus)
Time frame: During the surgical procedure
Vomiting During Stage II (After Eversion of the Uterus and Until Replacement of the Uterus)
Time frame: During the surgical procedure
Vomiting During Stage III (After Replacement of the Uterus and to the Next 15 Minutes)
Time frame: During the surgical procedure
Vomiting During Stage IV (the Rest of the Time Until Arrival at PACU)
Time frame: During the surgical procedure
Satisfaction of Anti-emetic Treatment
Time frame: During the surgical procedure
Overall Anesthetic Care Satisfaction
Time frame: During the surgical procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23076903Afolabi BB, Lesi FE. Regional versus general anaesthesia for caesarean section. Cochrane Database Syst Rev. 2012 Oct 17;10(10):CD004350. doi: 10.1002/14651858.CD004350.pub3.
- Background: PubMed 18043058Arnberger 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.
- Background: PubMed 16158876Chen 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.
- Background: PubMed 15321185Duggal 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.
- Background: PubMed 9085965Fan 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.
- Background: PubMed 15385352Gan 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.
- Background: PubMed 15947124Golembiewski 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.
- Background: PubMed 16428565Habib 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.
- Background: PubMed 10823097Harmon 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.
- Background: PubMed 8721471Ho 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.
- Background: PubMed 16492848Ho 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.
- Background: PubMed 1859764Lewis 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaul Cohen, MD principal investigator
Robert Wood Johnson University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acupressure Point P6 stimulator, Metoclopramide and Ondansetron in people with Nausea and Vomiting, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nausea (time frame: During the surgical procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02959840, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2017.