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

Rutgers The State University of New Jersey

Status and phase: Completed; Phase 4

Conditions: Vomiting; Nausea; Satisfaction

Treatments: Drug: scopolamine patch; Device: acupressure point P6

Study type: Interventional

Funder types: Other

Identifiers

NCT02960113

Pro20160000234

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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240 participants in 3 patient groups

scopolamine patch

Experimental group

Description:

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.

Treatment:

Drug: scopolamine patch

acupressure point P6

Experimental group

Description:

Acupressure point P6 stimulation will be placed on the distal right forearm just above the crest of the wrist.

Treatment:

Device: acupressure point P6

scopolamine patch + acupressure point P6

Experimental group

Description:

Will receive both scopolamine patch and acupressure point P6 stimulation, as described above.

Treatment:

Drug: scopolamine patch

Device: acupressure point P6