Clinical trial NCT02960113: Scopolamine Patch and Acupressure Point P6 Stimulation for Reduction of Nausea and Vomiting During Cesarean Section
Official title: 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?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nausea
Vomiting
Satisfaction
Keywords: cesarean section
acupressure point p6
scopolamine patch
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2016-11-09
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients With Nausea
timeFrame: Throughout the entire surgical procedure
measure: Number of Patients With Vomiting
timeFrame: Throughout the surgical procedure
Secondary outcomes:
measure: Satisfaction With Intraoperative Antiemetic Treatment
timeFrame: Throughout the surgical procedure
measure: Level of Nausea After the Administration of the Regional Anesthesia Medications
timeFrame: From administration of anaesthesia until eversion of uterus
measure: Level of Nausea After Eversion of the Uterus
timeFrame: After eversion of the uterus until replacement of the uterus
measure: Level of Nausea After Replacement of the Uterus
timeFrame: After replacement of the uterus and to the next 15 minutes
measure: Level of Nausea Upon Arrival to the Post-operative Recovery Room
timeFrame: 15 minutes after replacement of the uterus to arrival at post-anaesthesia care unit
measure: Number of Patients With Vomiting After the Administration of the Regional Anesthesia Medications
timeFrame: After the administration of the regional anesthesia medications until eversion of the uterus
measure: Number of Patients With Vomiting After Eversion of the Uterus
timeFrame: After eversion of to replacement of the uterus
measure: Number of Patients With Vomiting After Replacement of the Uterus
timeFrame: After replacement of the uterus and for next 15 minutes
measure: Number of Patients With Vomiting Upon Arrival to the Post-operative Recovery Room
timeFrame: From 15 minutes after replacement of the uterus until arrival at the post-anaesthesia care unit
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Robert Wood Johnson University Hospital
state: New Jersey
Study officials:
affiliation: Robert Wood Johnson University Hospital
name: Shaul Cohen, MD
role: PRINCIPAL_INVESTIGATOR
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