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Trial record 2 of 3 for:    21118734 [PUBMED-IDS]

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

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ClinicalTrials.gov Identifier: NCT02960113
Recruitment Status : Recruiting
First Posted : November 9, 2016
Last Update Posted : August 30, 2017
Sponsor:
Information provided by (Responsible Party):
Shaul Cohen, M.D., Rutgers, The State University of New Jersey

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.

Condition or disease Intervention/treatment Phase
Nausea Vomiting Satisfaction Drug: scopolamine patch Device: acupressure point P6 Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : May 2016
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: scopolamine patch
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
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

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

Experimental: scopolamine patch + acupressure point P6
Will receive both scopolamine patch and acupressure point P6 stimulation, as described above.
Drug: scopolamine patch
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

Device: acupressure point P6
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 Outcome Measures :
  1. Nausea [ Time Frame: During the 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. Vomiting [ Time Frame: During 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 Outcome Measures :
  1. Satisfaction [ Time Frame: During 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. Nausea after the administration of the regional anesthesia medications [ Time Frame: During the surgical procedure ]
    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. Nausea after eversion of the uterus [ Time Frame: During the surgical procedure ]
    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. Nausea after replacement of the uterus [ Time Frame: During the surgical procedure ]
    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. Nausea upon arrival to the post-operative recovery room [ Time Frame: During the surgical procedure ]
    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. Vomiting after the administration of the regional anesthesia medications [ Time Frame: During the surgical procedure ]
    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. Vomiting after eversion of the uterus [ Time Frame: During the surgical procedure ]
    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. Vomiting after replacement of the uterus [ Time Frame: During the surgical procedure ]
    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. Vomiting upon arrival to the post-operative recovery room [ Time Frame: During the surgical procedure ]
    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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02960113


Contacts
Contact: Shaul Cohen, MD 732-937-8841 cohensh@rwjms.rutgers.edu

Locations
United States, New Jersey
Robert Wood Johnson University Hospital Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Shaul Cohen, MD    732-937-8841    cohensh@rwjms.rutgers.edu   
Sub-Investigator: Danielle Levin, BA         
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
Principal Investigator: Shaul Cohen, MD Robert Wood Johnson University Hospital

Publications:

Responsible Party: Shaul Cohen, M.D., Director of Obstetric Anesthesia, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT02960113     History of Changes
Other Study ID Numbers: Pro20160000234
First Posted: November 9, 2016    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Shaul Cohen, M.D., Rutgers, The State University of New Jersey:
cesarean section
acupressure point p6
scopolamine patch

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Scopolamine Hydrobromide
Butylscopolammonium Bromide
Adjuvants, Anesthesia
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Parasympatholytics