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

• ClinicalTrials.gov Identifier: NCT02959840
• Recruitment Status: Completed
• First Posted: November 9, 2016
• Results First Posted: July 25, 2017
• Last Update Posted: September 25, 2017
• Sponsor: Rutgers, The State University of New Jersey
• Information provided by (Responsible Party): Shaul Cohen, M.D., Rutgers, The State University of New Jersey

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 (Clinical Trial)
• 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: July 2015
• Actual Primary Completion Date: March 2016
• Actual Study Completion Date: August 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 Name: Reglan; Drug: Ondansetron; 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia.; Other Name: 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 [ 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.
2. 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.

Secondary Outcome Measures :

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

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

United States, New Jersey

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

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.

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.

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.

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.

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.

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. doi: 10.1093/ajhp/62.12.1247.

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.

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.

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.

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.

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.

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• 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: November 9, 2016
• Results First Posted: July 25, 2017
• Last Update Posted: September 25, 2017
• Last Verified: August 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Nausea; Vomiting; Signs and Symptoms, Digestive; Ondansetron; Metoclopramide; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Antipruritics; Dermatologic Agents; Serotonin 5-HT3 Receptor Antagonists; Serotonin Antagonists; Serotonin Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Dopamine Agents