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

Phase 4

Completed

Conditions: Vomiting
Nausea
Satisfaction

Interventions: Drug: scopolamine patch
Device: acupressure point P6

Registration Number: NCT02960113

Lead Sponsor: Rutgers, The State University of New Jersey

Brief 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.

Detailed Description: Nausea and vomiting are very common and unpleasant events experienced during cesarean section under regional anesthesia and in the postoperative period following cesarean section. These side effects are distressing for both the parturient and her family. In addition, intraoperative vomiting causes significant challenges for the surgeon, such as increased procedure length, increased risk of bleeding, increased risk of gastric content aspiration, and potential surgical trauma.

To combat the nausea and vomiting seen in all above anesthetic modalities, but to a greater degree in regional anesthesia, a number of pharmacological interventions are currently used with varying degrees of effectiveness in the perioperative period. These medications come from a wide range of drug classes including serotonin and dopamine receptor antagonists, corticosteroids, antihistamines, sedatives and anticholinergics.

In our study, we would like to compare the effectiveness of antiemetic agents or technique which cause less severe adverse reactions to the mother and her fetus. Out of the available pharmacological agents for reduction of intra-cesarean section nausea and vomiting, transdermal scopolamine patch is one of the safest medications. We would like to compare the effectiveness of the transdermal scopolamine patch with acupressure point P6 stimulation versus just transdermal scopolamine patch versus just acupressure point P6 stimulation.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 240

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
scopolamine patch	scopolamine patch	Scopolamine patch will be placed on the skin behind the right ear 1 hour before initiation of the regional anesthesia for the duration of surgery.
acupressure point P6	acupressure point P6	Acupressure point P6 stimulation will be placed on the distal right forearm just above the crest of the wrist.
scopolamine patch + acupressure point P6	scopolamine patch	Will receive both scopolamine patch and acupressure point P6 stimulation, as described above.
scopolamine patch + acupressure point P6	acupressure point P6	Will receive both scopolamine patch and acupressure point P6 stimulation, as described above.

Primary Outcome Measures

Name	Time	Method
Number of Patients With Vomiting	Throughout the surgical procedure	The investigators will perform objective assessments of whether or not the patients have vomited during the procedure. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group.
Number of Patients With Nausea	Throughout the entire surgical procedure	The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea at any point during the surgical procedure in each group.

Secondary Outcome Measures

Name	Time	Method
Satisfaction With Intraoperative Antiemetic Treatment	Throughout the surgical procedure	Patients are asked their nausea and vomiting treatment satisfaction (0 = Not Satisfied, 10 = Extremely Satisfied). Patients are also asked their overall satisfaction with the procedure (0 = Not Satisfied, 10 = Extremely Satisfied).
Level of Nausea After the Administration of the Regional Anesthesia Medications	From administration of anaesthesia until eversion of uterus	Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) after the administration of the regional anesthesia medications. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea.
Level of Nausea After Eversion of the Uterus	After eversion of the uterus until replacement of the uterus	Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) after eversion of the uterus. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea.
Level of Nausea After Replacement of the Uterus	After replacement of the uterus and to the next 15 minutes	Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) after replacement of the uterus. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea.
Level of Nausea Upon Arrival to the Post-operative Recovery Room	15 minutes after replacement of the uterus to arrival at post-anaesthesia care unit	Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) upon arrival to the post-operative recovery room. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea.
Number of Patients With Vomiting After Eversion of the Uterus	After eversion of to replacement of the uterus	Objective assessments of whether or not the patients have vomited at this point in the surgical procedure will be done. The investigators will analyze if there is a statistically significant difference between the number of patients that vomit in each group.
Number of Patients With Vomiting After Replacement of the Uterus	After replacement of the uterus and for next 15 minutes	Objective assessments of whether or not the patients have vomited at this point in the surgical procedure will be done. The investigators will analyze if there is a statistically significant difference between the number of patients that vomit in each group.
Number of Patients With Vomiting After the Administration of the Regional Anesthesia Medications	After the administration of the regional anesthesia medications until eversion of the uterus	Objective assessments of whether or not the patients have vomited at this point in the surgical procedure will be done. The investigators will analyze if there is a statistically significant difference between the number of patients that vomit in each group.
Number of Patients With Vomiting Upon Arrival to the Post-operative Recovery Room	From 15 minutes after replacement of the uterus until arrival at the post-anaesthesia care unit	Objective assessments of whether or not the patients have vomited at this point in the surgical procedure will be done. The investigators will analyze if there is a statistically significant difference between the number of patients that vomit in each group.