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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Is the Application of Scopolamine Patch With or Without Intra-operative Acupressure Point P6 Stimulation More Effective Than Intra-operative Acupressure Point P6 Stimulation Alone?

Conditions
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Nausea, Vomiting, Satisfaction

Intervention / Treatment
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* Drug: scopolamine patch
* Device: acupressure point P6


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: scopolamine patch<br>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. | Drug: scopolamine patch<br>* Group I (n=80): Will receive scopolamine patch placement on the skin behind the right ear 1 hour before initiation of the regional anesthesia for the duration of surgery. The time of the application of the patch will be recorded, and the time of the start of the surgery will be recorded. The last time point for evaluation of patient's nausea/vomiting will be when the patient arrives to the post anesthesia care unit. A member of the research team will remove the patch from the patient and properly dispose the patch upon arrival to the post anesthesia care unit.<br>* Other names: Maldemar;|
| Experimental: acupressure point P6<br>Acupressure point P6 stimulation will be placed on the distal right forearm just above the crest of the wrist. | Device: acupressure point P6<br>* Group II (n=80): Will receive acupressure point P6 stimulation. This is a stimulation of the chi channel at the master of the heart (MH8 position) at the small depression of the volar surface of the distal right forearm just above the crest of the wrist. The device will be put on the patients in the operating room prior to administration of the regional anesthesia and will be removed after the cesarean section is complete. The device will be removed from the patient in the operating room, before the patient is transported to the recovery room. Patients will receive continuous stimulation at a level that is comfortable for her prior to administration of the standardized regional anesthesia.<br>|
| Experimental: scopolamine patch + acupressure point P6<br>Will receive both scopolamine patch and acupressure point P6 stimulation, as described above. | Drug: scopolamine patch<br>* Group I (n=80): Will receive scopolamine patch placement on the skin behind the right ear 1 hour before initiation of the regional anesthesia for the duration of surgery. The time of the application of the patch will be recorded, and the time of the start of the surgery will be recorded. The last time point for evaluation of patient's nausea/vomiting will be when the patient arrives to the post anesthesia care unit. A member of the research team will remove the patch from the patient and properly dispose the patch upon arrival to the post anesthesia care unit.<br>* Other names: Maldemar;Device: acupressure point P6<br>* Group II (n=80): Will receive acupressure point P6 stimulation. This is a stimulation of the chi channel at the master of the heart (MH8 position) at the small depression of the volar surface of the distal right forearm just above the crest of the wrist. The device will be put on the patients in the operating room prior to administration of the regional anesthesia and will be removed after the cesarean section is complete. The device will be removed from the patient in the operating room, before the patient is transported to the recovery room. Patients will receive continuous stimulation at a level that is comfortable for her prior to administration of the standardized regional anesthesia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Nausea | 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. | Throughout the entire surgical procedure | 
| Number of Patients With Vomiting | 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. | Throughout the surgical procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction With Intraoperative Antiemetic Treatment | 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). | Throughout the surgical procedure | 
| Level of Nausea After the Administration of the Regional Anesthesia Medications | 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. | From administration of anaesthesia until eversion of uterus | 
| Level of Nausea After Eversion 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. | After eversion of the uterus until replacement of the uterus | 
| Level of Nausea After 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 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. | After replacement of the uterus and to the next 15 minutes | 
| Level of Nausea Upon Arrival to the Post-operative Recovery Room | 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. | 15 minutes after replacement of the uterus to arrival at post-anaesthesia care unit | 
| Number of Patients With Vomiting After the Administration of the Regional Anesthesia Medications | 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. | After the administration of the regional anesthesia medications until eversion of the uterus | 
| Number of Patients With Vomiting After 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. | After eversion of to replacement of the uterus | 
| Number of Patients With Vomiting After 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. | After replacement of the uterus and for next 15 minutes | 
| Number of Patients With Vomiting Upon Arrival to the Post-operative Recovery Room | 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. | From 15 minutes after replacement of the uterus until arrival at the post-anaesthesia care unit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cesarean section, acupressure point p6, scopolamine patch