Phase 4
Completed N=240
Scopolamine Patch and Acupressure Point P6 Stimulation for Reduction of Nausea and Vomiting During Cesarean Section
Source: ClinicalTrials.gov NCT02960113 ↗Enrolled (actual)
240
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcomePrimary: Number of Patients With Nausea — 40; 39; 46 Participants — p=0.98
◆ 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 reducing intra-cesarean section nausea and vomiting with regional anesthesia in subjects who will receive scopolamine patch with acupressure point P6 stimulation versus subjects that receive just scopolamine patch versus subjects that receive just acupressure point P6 stimulation.
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 Number of Patients With Nausea |
40; 39; 46 | 0.98 |
| PRIMARY Number of Patients With Vomiting |
24; 25; 31 | 0.90 |
| SECONDARY Satisfaction With Intraoperative Antiemetic Treatment |
9.29; 8.96; 9.59 | 0.026 sig |
| SECONDARY Level of Nausea After the Administration of the Regional Anesthesia Medications |
2.71; 2.57; 2.84 | 0.91 |
| SECONDARY Level of Nausea After Eversion of the Uterus |
1.28; 1.09; 1.40 | 0.80 |
| SECONDARY Level of Nausea After Replacement of the Uterus |
2.19; 2.19; 2.51 | 0.82 |
| SECONDARY Level of Nausea Upon Arrival to the Post-operative Recovery Room |
0.18; 0.25; 0.23 | 0.93 |
| SECONDARY Number of Patients With Vomiting After the Administration of the Regional Anesthesia Medications |
20; 15; 20 | 0.55 |
| SECONDARY Number of Patients With Vomiting After Eversion of the Uterus |
8; 6; 9 | 0.71 |
| SECONDARY Number of Patients With Vomiting After Replacement of the Uterus |
10; 15; 12 | 0.55 |
| SECONDARY Number of Patients With Vomiting Upon Arrival to the Post-operative Recovery Room |
1; 1; 4 | 0.20 |
Eligibility Criteria
Inclusion Criteria
- Female subjects ages 18 to 45
- Subjects with ASA Class I or II
- Subjects with elective primary or repeat cesarean delivery
- Subjects who receive spinal and/or 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
- Gestational age < 37 weeks
- History of placenta accreta
- 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
- Coagulopathies or skin infections overlying the spine
- History of open angle glaucoma, seizures or psychosis
Data sourced from ClinicalTrials.gov (NCT02960113) 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.