Phase 4 N=240 Randomized Single-blind Prevention

Scopolamine Patch and Acupressure Point P6 Stimulation for Reduction of Nausea and Vomiting During Cesarean Section

Nausea · Vomiting · Satisfaction

Bottom Line

View on ClinicalTrials.gov: NCT02960113 ↗

Enrolled (actual)

240

Serious AEs

0.0%

Results posted

Dec 2022

Primary outcome: Primary: Number of Patients With Nausea — 40; 39; 46 Participants — p=0.98

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: scopolamine patch (Drug); acupressure point P6 (Device)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Rutgers, The State University of New Jersey
Primary completion: Sep 2021

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

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02960113). 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.