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Completed

NCT Number: NCT02960113

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

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.

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Key information

Conditions

Nausea Behavior Pathological Conditions, Signs and Symptoms Personal Satisfaction Satisfaction Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

scopolamine patch

Drug

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.

Other names: Transderm-Scop, Scopace, Maldemar

acupressure point P6

Device

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.

Primary outcomes

  1. Number of Patients With Nausea

    Time frame: 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.

  2. Number of Patients With Vomiting

    Time frame: 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.

Secondary outcomes

  1. Satisfaction With Intraoperative Antiemetic Treatment

    Time frame: 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).

  2. Level of Nausea After the Administration of the Regional Anesthesia Medications

    Time frame: 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.

  3. Level of Nausea After Eversion of the Uterus

    Time frame: 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.

  4. Level of Nausea After Replacement of the Uterus

    Time frame: 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.

  5. Level of Nausea Upon Arrival to the Post-operative Recovery Room

    Time frame: 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.

  6. Number of Patients With Vomiting After the Administration of the Regional Anesthesia Medications

    Time frame: 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.

  7. Number of Patients With Vomiting After Eversion of the Uterus

    Time frame: 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.

  8. Number of Patients With Vomiting After Replacement of the Uterus

    Time frame: 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.

  9. Number of Patients With Vomiting Upon Arrival to the Post-operative Recovery Room

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Registry information

Official study 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?

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Nov 9, 2016
Registry last updated
Dec 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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