Phase 4
Completed N=180
Acupuncture Point P6 Stimulation for Reduction of Nausea and Vomiting During Cesarean
Source: ClinicalTrials.gov NCT02959840 ↗Enrolled (actual)
180
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcomePrimary: Nausea — 44; 14; 22 Participants — p=< 0.00001
◆ Published Evidence
Established
37citations · ~7 / year
Interventions for preventing nausea and vomiting in women undergoing regional anaesthesia for caesarean section.
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.
Linked Publications
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Interventions for preventing nausea and vomiting in women undergoing regional anaesthesia for caesarean section.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Nausea |
44; 14; 22 | < 0.00001 sig |
| PRIMARY Vomiting |
27; 10; 8 | 0.001 sig |
| SECONDARY Nausea During Stage I (After the Administration of CSE and Until Eversion of the Uterus) |
33; 7; 14 | 0.00004 sig |
| SECONDARY Nausea During Stage II (After Eversion of the Uterus and Until Replacement of the Uterus) |
12; 6; 5 | 0.1 |
| SECONDARY Nausea During Stage III (After Replacement of the Uterus and to the Next 15 Minutes) |
16; 8; 14 | 0.7 |
| SECONDARY Nausea During Stage IV (the Rest of the Time Until Arrival at PACU) |
3; 4; 0 | 1 |
| SECONDARY Vomiting During Stage I (After the Administration of CSE and Until Eversion of the Uterus) |
20; 5; 4 | 0.001 sig |
| SECONDARY Vomiting During Stage II (After Eversion of the Uterus and Until Replacement of the Uterus) |
10; 1; 3 | 0.008 sig |
| SECONDARY Vomiting During Stage III (After Replacement of the Uterus and to the Next 15 Minutes) |
9; 4; 6 | 0.2 |
| SECONDARY Vomiting During Stage IV (the Rest of the Time Until Arrival at PACU) |
0; 2; 0 | 0.5 |
| SECONDARY Satisfaction of Anti-emetic Treatment |
49; 58; 55 | 0.02 sig |
| SECONDARY Overall Anesthetic Care Satisfaction |
53; 58; 56 | 0.2 |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02959840) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.