Accupressure of P6 to Reduce Nausea During Cesarean Section

Pregnancy Related Clinical Trial

Official title:

The Use of P6 Acupressure for the Reduction of Intraoperative and Postoperative Nausea and Vomiting in Women Undergoing Cesarean Delivery: a Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04799587
• Other study ID #: STU#: 00213854
• Status: Completed
• Phase: N/A
• Start date: May 26, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: October 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 30, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• =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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Cesarean Delivery
• Nausea
• Pregnancy Related
• Vomiting

Intervention

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

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (14)

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. Erratum In: J Clin Diagn Res. 2015 Jul;9(7):ZZ03. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of emesis during scheduled cesarean delivery	Presence of emesis during the scheduled cesarean delivery	Delivery of baby
Secondary	Presence of nausea during scheduled cesarean delivery	The presence of nausea during the scheduled cesarean delivery.	Delivery of baby
Secondary	presence of nausea after scheduled cesarean delivery	The presence of nausea after scheduled cesarean delivery	48 hours after delivery of baby
Secondary	Maternal satisfaction of the IONV/PONV management using a VAS	Maternal satisfaction with IONV/PONV medical management using a sliding VAS (visual analog scale) of 0 representing poor satisfaction and 10 representing greatest level of satisfaction.; The maternal satisfaction with intraoperative and postoperative nausea and vomiting management.	48 hours after delivery of baby
Secondary	Number of antiemetic rescue medications given during the intraoperative period	Total number of additional antiemetic rescue medications given during the intraoperative period.	End of surgery
Secondary	Number of additional antiemetic rescue medications given postoperatively	Total number of number of additional antiemetic rescue medications given during the post operative period.	48 hours after surgery