Accupressure of P6 to Reduce Nausea During Cesarean Section

Study Overview
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Brief Summary
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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.

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

Conditions
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Pregnancy Related, Cesarean Delivery, Nausea, Vomiting

Intervention / Treatment
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* Other: Magnet at P6
* Other: Magnet applied to arm not at P6 pressure point.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two group, sham vs actual location of pressure point.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: P6 Accupressure Group<br>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<br>* 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.<br>|
| Sham Comparator: Sham Pressure Point<br>The sham pressure point (distal to the P6 acupressure point). | Other: Magnet applied to arm not at P6 pressure point.<br>* Magnet applied to arm not at P6 pressure point and affixed with adhesive tape.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of emesis during scheduled cesarean delivery | 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 | The presence of nausea during the scheduled cesarean delivery. | Delivery of baby | 
| presence of nausea after scheduled cesarean delivery | The presence of nausea after scheduled cesarean delivery | 48 hours after delivery of baby | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Accupressure, Cesarean Delivery, Nausea, Vomiting