- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04799587
Accupressure of P6 to Reduce Nausea During Cesarean Section
February 28, 2024 updated by: Feyce M. Peralta, MD, MS, Northwestern University
The Use of P6 Acupressure for the Reduction of Intraoperative and Postoperative Nausea and Vomiting in Women Undergoing Cesarean Delivery: a Randomized Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Feyce Peralta, MD
- Phone Number: 312-472-3585
- Email: feyce.peralta@northwestern.edu
Study Contact Backup
- Name: Paul Fitzgerald, RN, BSN,MS
- Phone Number: 312-695-1064
- Email: p-fitzgerald2@northwestern.edu
Study Locations
-
-
Illinois
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Chicago, Illinois, United States, 60611
- Northwestern Memorial Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: P6 Accupressure Group
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.
|
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.
|
Sham Comparator: Sham Pressure Point
The sham pressure point (distal to the P6 acupressure point).
|
Magnet applied to arm not at P6 pressure point and affixed with adhesive tape.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Presence of emesis during scheduled cesarean delivery
Time Frame: Delivery of baby
|
Presence of emesis during the scheduled cesarean delivery
|
Delivery of baby
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Presence of nausea during scheduled cesarean delivery
Time Frame: Delivery of baby
|
The presence of nausea during the scheduled cesarean delivery.
|
Delivery of baby
|
presence of nausea after scheduled cesarean delivery
Time Frame: 48 hours after delivery of baby
|
The presence of nausea after scheduled cesarean delivery
|
48 hours after delivery of baby
|
Maternal satisfaction of the IONV/PONV management using a VAS
Time Frame: 48 hours after delivery of baby
|
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
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Number of antiemetic rescue medications given during the intraoperative period
Time Frame: End of surgery
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Total number of additional antiemetic rescue medications given during the intraoperative period.
|
End of surgery
|
Number of additional antiemetic rescue medications given postoperatively
Time Frame: 48 hours after surgery
|
Total number of number of additional antiemetic rescue medications given during the post operative period.
|
48 hours after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Feyce Peralta, MD, Northwestern University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 26, 2021
Primary Completion (Actual)
August 31, 2023
Study Completion (Actual)
September 30, 2023
Study Registration Dates
First Submitted
February 26, 2021
First Submitted That Met QC Criteria
March 11, 2021
First Posted (Actual)
March 16, 2021
Study Record Updates
Last Update Posted (Estimated)
February 29, 2024
Last Update Submitted That Met QC Criteria
February 28, 2024
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU#: 00213854
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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