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

NCT02959840 | Completed Phase 4 Results

• 1 other identifier: Pro20140000517
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Nausea; Vomiting; Satisfaction

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  During the surgical procedure

Secondary Outcomes (10)

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

  During the surgical procedure

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

  During the surgical procedure

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

  During the surgical procedure

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

  During the surgical procedure

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

  During the surgical procedure

Study Arms (3)

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

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.

Device: Acupressure Point P6 stimulator

Interventions

Acupressure Point P6 stimulator DEVICE

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.

Acupressure Point P6 stimulator

Metoclopramide DRUG

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

Also known as: Reglan

Metoclopramide, Ondansetron

Ondansetron DRUG

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

Also known as: Zofran

Metoclopramide, Ondansetron

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901, United States

Location

Related Publications (16)

• 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.

  PMID: 23076903 BACKGROUND

• 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.

  PMID: 18043058 BACKGROUND

• 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.

  PMID: 16158876 BACKGROUND

• 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.

  PMID: 15321185 BACKGROUND

• 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.

  PMID: 9085965 BACKGROUND

• 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.

  PMID: 15385352 BACKGROUND

• 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.

  PMID: 15947124 BACKGROUND

• 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.

  PMID: 16428565 BACKGROUND

• 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.

  PMID: 10823097 BACKGROUND

• 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.

  PMID: 8721471 BACKGROUND

• 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.

  PMID: 16492848 BACKGROUND

• 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.

  PMID: 1859764 BACKGROUND

• 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.

  PMID: 9024025 BACKGROUND

• 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.

  PMID: 12411789 BACKGROUND

• 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.

  PMID: 11226090 BACKGROUND

• 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.

  PMID: 34002866 DERIVED

MeSH Terms

Conditions

Nausea; Vomiting; Personal Satisfaction

Interventions

Metoclopramide; Ondansetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Results Point of Contact

• Title: Dr. Shaul Cohen, M.D., Professor of Clinical Anesthesiology, Director of Obstetric Anesthesia
• Organization: Rutgers-Robert Wood Johnson Medical School

cohensh@rwjms.rutgers.edu

732-937-8841

Study Officials

• Shaul Cohen, MD

  Robert Wood Johnson University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Obstetric Anesthesia

Study Record Dates

• First Submitted: October 10, 2016
• First Posted: November 9, 2016
• Study Start: July 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: August 23, 2017
• Last Updated: September 25, 2017
• Results First Posted: July 25, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)