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Risk Factors for Postoperative Nausea, Vomiting and Pruritus

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ClinicalTrials.gov Identifier: NCT03178058
Recruitment Status : Recruiting
First Posted : June 6, 2017
Last Update Posted : June 6, 2017
Sponsor:
Information provided by (Responsible Party):
sharon orbach, Rabin Medical Center

Brief Summary:
In this study we would like to identify demographic and individual risk factors that place parturients at a higher risk for postoperative nausea and vomiting (PONV) and itching following administered neuraxial morphine for cesarean section. Our primary objective is to develop a reliable predictive neuraxial morphine induced nausea and vomiting (NMINV) and itching model.

Condition or disease Intervention/treatment
Postoperative Nausea and Vomiting Other: Questionaire

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk Factors for Nausea, Vomiting and Pruritus After Neuraxial Morphine for Cesarean Section
Study Start Date : October 2016
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Parturients for CS

Parturients presenting for Cesarean section will be enrolled preoperatively. Prior to surgery women will be given a questionnaire detailing previous motion sickness, previous history of PONV, emesis during pregnancy, smoking history , itching history, skin atopy and allergies. After surgery details about surgery will be added: intraoperative hypotension, use of phenylepherine, intraoperative nausea and vomiting, exteriorization of uterus, extent of adhesions, need for uterotonic medications, and estimated bleeding.

Parturients will be assessed 1 hour and 24 postoperatively by attending anesthesiologist, PONV incidence will be reported using a three point ordinal scale (0 = none, 1 = nausea, 2 = retching, 3 =vomiting).

Other: Questionaire

Prior to surgery women will be given a questionnaire detailing previous motion sickness, previous history of PONV, emesis during pregnancy, smoking history , itching history, skin atopy and allergies. After surgery details about surgery will be added: intraoperative hypotension, use of phenylepherine, intraoperative nausea and vomiting, exteriorization of uterus, extent of adhesions, need for uterotonic medications, and estimated bleeding.

Parturients will be assessed 1 hour and 24 postoperatively by attending anesthesiologist, PONV incidence will be reported using a three point ordinal scale (0 = none, 1 = nausea, 2 = retching, 3 =vomiting).





Primary Outcome Measures :
  1. Demographic causative factors for postoperative nausea after administration of neuraxial morphine [ Time Frame: 24 Hours ]
    Demographic factors that contribute to postoperative nausea after administration of neuraxial morphine as measured by the PONV questionnaire


Secondary Outcome Measures :
  1. Demographic causative factors for postoperative vomiting after administration of neuraxial morphine [ Time Frame: 24 hours ]
    emographic factors that contribute to postoperative vomiting after administration of neuraxial morphine as measured by the PONV questionnaire

  2. Demographic causative factors for postoperative pruritus after administration of neuraxial morphine [ Time Frame: 24 hours ]
    Demographic factors that contribute to postoperative pruritus after administration of neuraxial morphine as measured by the PONV questionnaire



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study cohort consists of parturients presenting for cesarean section under spinal anesthesia with intrathecal morphine above the age 18.
Criteria

Inclusion Criteria:

  • Women over 18 undergoing cesarean section under spinal anesthesia with intrathecal morphine in Beilinson Hospital following obtaining written informed consents forums with the ability to comply with the study requirements will be included in our study.

Exclusion Criteria:

  • Women under age 18, women undergoing cesarean section under general anesthesia or under spinal anesthesia without intrathecal morphine and women who don't understand the inform consent form will be excluded from participating.

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): NCT03178058


Locations
Israel
Beilinson hospital Recruiting
Petach tikvah, Israel
Contact: Sharon Orbach, MD    972-54-538-3093    sharonorbach@yahoo.com   
Principal Investigator: Sharon Orbach-zinger         
Sub-Investigator: Elyia Obibook         
Principal Investigator: Eitan Razinski         
Sponsors and Collaborators
Rabin Medical Center

Responsible Party: sharon orbach, Dr, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT03178058     History of Changes
Other Study ID Numbers: 0387-15
First Posted: June 6, 2017    Key Record Dates
Last Update Posted: June 6, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Nausea
Vomiting
Postoperative Nausea and Vomiting
Pruritus
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Skin Diseases
Skin Manifestations