Accupressure of P6 to Reduce Nausea During Cesarean Section

NCT04799587 | Completed Results DMC

• 1 other identifier: STU#: 00213854
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate if the addition of P6 pressure point stimulation as opposed to sham-point stimulation will decrease intraoperative and postoperative nausea and vomiting (IONV and PONV) for patients undergoing non-emergent cesarean delivery. We hypothesize that the addition of stimulation of the P6 pressure point to our institutional current standard of care (phenylephrine infusion, intravenous fluid bolus, and as needed intraoperative ondansetron) will decrease the occurrence of intraoperative emesis.

Conditions

Pregnancy Related; Cesarean Delivery; Nausea; Vomiting

Keywords

Accupressure; Cesarean Delivery; Nausea; Vomiting

Outcome Measures

Primary Outcomes (2)

• Presence of Intraoperative Vomiting

  Presence of intraoperative vomiting during scheduled cesarean delivery (intraoperative period).

  Intraoperative Period

• Presence of Intraoperative Nausea

  Presence of intraoperative nausea during scheduled cesarean delivery (intraoperative period).

  Intraoperative period

Secondary Outcomes (2)

• Number of Emesis Episodes in the Intraoperative Period Period

  Intraoperative period

• Number of Rescue Antiemetic Doses Administered for the Treatment of Intraoperative Nausea and Vomiting

  Intraoperative period

Other Outcomes (18)

• The Number of Emesis From Post Anesthesia Care Unit to Discharge.

  96 hours

• Antiemetic Medication Administered From the PACU Through Discharge

  96 hours

• Patient Questionnaire: Have You Experienced Dry Retching or Vomiting

  96 Hours

Study Arms (2)

P6 Accupressure Group

ACTIVE COMPARATOR

The pressure point will be stimulated by the presence of the magnet when positioned properly on the P6 acupressure point. Additional pressure may be applied as desired by the study subject but is not necessary for P6 stimulation.

Other: Magnet at P6

Sham Pressure Point

SHAM COMPARATOR

The sham pressure point (distal to the P6 acupressure point).

Other: Magnet applied to arm not at P6 pressure point.

Interventions

Magnet at P6 OTHER

Magnet applied at P6 and attached with adhesive tape. The P6 pressure point is 2 inches proximal to the flexor retinaculum, between the flexor carpi radialis and palmaras longus.

P6 Accupressure Group

Magnet applied to arm not at P6 pressure point. OTHER

Magnet applied to arm not at P6 pressure point and affixed with adhesive tape.

Sham Pressure Point

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnancy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age
• English-speaking
• Pregnant patients presenting for scheduled cesarean delivery of a full-term fetus (\>37 weeks' gestation)
• Patients scheduled as ERAC
• Parturients undergoing spinal anesthesia

You may not qualify if:

• Patients requiring emergent delivery,
• Fetal demise
• Patients with adhesive allergy/sensitivity
• Patients with allergy/sensitivity to nickel,
• Patients with inability to consent,
• Patients with known abnormal placentation
• Patients with pacemakers/defibrillators
• Patients with positive COVID-19 tests

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (14)

• Balki M, Carvalho JC. Intraoperative nausea and vomiting during cesarean section under regional anesthesia. Int J Obstet Anesth. 2005 Jul;14(3):230-41. doi: 10.1016/j.ijoa.2004.12.004.

  PMID: 15935649 BACKGROUND

• Chooi C, Cox JJ, Lumb RS, Middleton P, Chemali M, Emmett RS, Simmons SW, Cyna AM. Techniques for preventing hypotension during spinal anaesthesia for caesarean section. Cochrane Database Syst Rev. 2017 Aug 4;8(8):CD002251. doi: 10.1002/14651858.CD002251.pub3.

  PMID: 28976555 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

• Albooghobeish M, Mohtadi A, Saidkhani V, Fallah H, Behaein K, Nesionpour S, Nikbakht R. Comparison Between Effects of Acupuncture and Metoclopramide on Postoperative Nausea and Vomiting after Gynaecological Laparoscopy: A Randomized Controlled Trial. Anesth Pain Med. 2017 Aug 22;7(5):e12876. doi: 10.5812/aapm.12876. eCollection 2017 Oct.

  PMID: 29696109 BACKGROUND

• Lee A, Fan LT. Stimulation of the wrist acupuncture point P6 for preventing postoperative nausea and vomiting. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD003281. doi: 10.1002/14651858.CD003281.pub3.

  PMID: 19370583 BACKGROUND

• Matthews A, Haas DM, O'Mathuna DP, Dowswell T. Interventions for nausea and vomiting in early pregnancy. Cochrane Database Syst Rev. 2015 Sep 8;2015(9):CD007575. doi: 10.1002/14651858.CD007575.pub4.

  PMID: 26348534 BACKGROUND

• Allen TK, Habib AS. P6 stimulation for the prevention of nausea and vomiting associated with cesarean delivery under neuraxial anesthesia: a systematic review of randomized controlled trials. Anesth Analg. 2008 Oct;107(4):1308-12. doi: 10.1213/ane.0b013e31816d1864.

  PMID: 18806045 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

• El-Deeb AM, Ahmady MS. Effect of acupuncture on nausea and/or vomiting during and after cesarean section in comparison with ondansetron. J Anesth. 2011 Oct;25(5):698-703. doi: 10.1007/s00540-011-1198-0. Epub 2011 Jul 15.

  PMID: 21761206 BACKGROUND

• Tan JY, Suen LK, Wang T, Molassiotis A. Sham Acupressure Controls Used in Randomized Controlled Trials: A Systematic Review and Critique. PLoS One. 2015 Jul 15;10(7):e0132989. doi: 10.1371/journal.pone.0132989. eCollection 2015.

  PMID: 26177378 BACKGROUND

• Wengritzky R, Mettho T, Myles PS, Burke J, Kakos A. Development and validation of a postoperative nausea and vomiting intensity scale. Br J Anaesth. 2010 Feb;104(2):158-66. doi: 10.1093/bja/aep370. Epub 2009 Dec 26.

  PMID: 20037151 BACKGROUND

• Boogaerts JG, Vanacker E, Seidel L, Albert A, Bardiau FM. Assessment of postoperative nausea using a visual analogue scale. Acta Anaesthesiol Scand. 2000 Apr;44(4):470-4. doi: 10.1034/j.1399-6576.2000.440420.x.

  PMID: 10757584 BACKGROUND

• Sheldon RR, Loughren MJ, Marenco CW, Winters JR, Bingham JR, Martin MJ, Eckert MJ, Burney RO. Microdermal Implants Show No Effect on Surrounding Tissue During Surgery With Electrocautery. J Surg Res. 2019 Sep;241:72-77. doi: 10.1016/j.jss.2019.03.039. Epub 2019 Apr 19.

  PMID: 31009888 BACKGROUND

• A DM, A K. Effect of acupressure on post-operative nausea and vomiting in cesarean section: a randomised controlled trial. J Clin Diagn Res. 2013 Oct;7(10):2247-9. doi: 10.7860/JCDR/2013/5702.3485. Epub 2013 Oct 5.

  PMID: 24298488 BACKGROUND

MeSH Terms

Conditions

Nausea; Vomiting

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

* Our study was underpowered to observe a difference between the groups at the rates of IONV observed. * Could be an element of patient bias and skepticism among Western women as to the effectiveness of non-pharmacologic therapy for the treatment of nausea and vomiting. * The chosen dose of intrathecal dose of morphine 150 mcg used in this study is higher than that recommended in the PROSPECT guidelines. * Uterine exteriorization is routinely performed in our practice, could increase IONV.

Results Point of Contact

• Title: Paul Fitzgerald, RN, BSN,MS
• Organization: Northwestern University

p-fitzgerald2@northwestern.edu

312-695-1064

Study Officials

• Feyce Peralta, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant will not know whether the pressure point is correct or sham location.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two group, sham vs actual location of pressure point.

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 16, 2021
• Study Start: May 26, 2021
• Primary Completion: August 31, 2023
• Study Completion: September 30, 2023
• Last Updated: June 6, 2025
• Results First Posted: June 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)