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



Status:Recruiting
Healthy:No
Age Range:18 - 45
Updated:11/11/2018
Start Date:May 2016
End Date:December 2019
Contact:Shaul Cohen, MD
Email:cohensh@rwjms.rutgers.edu
Phone:732-937-8841

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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?

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.

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.

Inclusion Criteria:

1. Female subjects ages 18 to 45

2. Subjects with ASA Class I or II

3. Subjects with elective primary or repeat cesarean delivery

4. Subjects who receive spinal and/or epidural anesthesia

5. English and non-English speaking subjects will be included in the study

Exclusion Criteria:

1. Female subjects <18 years of age

2. Subjects requiring emergent cesarean delivery

3. Gestational age < 37 weeks

4. History of placenta accreta

5. Multiple gestation pregnancy

6. ASA status III or higher

7. Current history of pregnancy induced hypertension, pre-eclampsia, or eclampsia

8. History of any chronic medication use (other than prenatal vitamins), including
inhaler medications

9. Current urinary tract infection, pneumonia, or otitis media

10. Coagulopathies or skin infections overlying the spine

11. History of open angle glaucoma, seizures or psychosis
We found this trial at
1
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New Brunswick, New Jersey 08903
Phone: 732-937-8841
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New Brunswick, NJ
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