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Postoperative Nausea and VomitingNCT03178058

Risk Factors for Postoperative Nausea, Vomiting and Pruritus

An observational study of Postoperative Nausea and Vomiting, run by Rabin Medical Center at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Postoperative Nausea and Vomiting
What is being tested?
Questionaire
How many people
100 participants
Where
1 siteIsrael
Study dates
Oct 2016to Dec 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The study cohort consists of parturients presenting for cesarean section under spinal anesthesia with intrathecal morphine above the age 18.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Israel1 site, 1 recruiting
  • Beilinson hospital

    Petach Tikvah

    Sharon Orbach, MD, 972-54-538-3093, sharonorbach@yahoo.com

    Sharon Orbach-zinger

    Recruiting

Other trials in Israel

About this study

Official title: Risk Factors for Nausea, Vomiting and Pruritus After Neuraxial Morphine for Cesarean Section

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.

Read the detailed description

Introduction Neuraxial morphine provides effective and long-lasting analgesia after cesarean section. It is currently considered the gold standard for postoperative pain. However, it is associated with problematic side effects including nausea and vomiting, pruritus, and rarely respiratory depression.

Postoperative nausea and vomiting (PONV) occurs in up to 60-80% of parturients receiving neuraxial opioid administration , and reported incidence of pruritus varies from 30% to 100%.

A wide range of pharmaceutical and non pharmaceutical agents are commonly used in clinical practice for the treatment and prophylaxis of neuraxial morphine induced postoperative nausea, vomiting and pruritus. Antiemetic medications such as droperidol, dexamethasone, metoclopramide and ondansetron, have been studied for their efficacy in preventing PONV . Despite the wide variety of these available drugs, many of them are ineffective and have side effects. Dexamethasone ,for example, although it has been proven as an effective antiemetic in patients receiving epidural morphine, it is ineffective monotherapy in patients receiving intrathecal morphine . In addition it is associated severe perineal pruritus . Common side effects of ondansetron are headache, flushing, dizziness and constipation. Droperidol is associated with undesirable side effects: sedation, hypotension, and extrapy-ramidal reactions . Both droperidol and ondansetron are known to prolong the QTc interval.

To date although pruritus after neuraxial administration of morphine is a common side effect, there is little available effective treatment . Studies have found opioid-induced pruritus to be dose dependent and minimal analgesic doses of opioids are recommended. Several agents from numerous drug families have been employed, although none has proved to be totally effective . Treatment medications include: naloxone, nalbuphine, diphenhydramine and droperidol .

To date there are no studies which have identified risk factors for PONV and pruritus after administration of nauraxial morphine. Attempts have been made to identify which patients are at risk for PONV after general anesthesia .

There are anesthetic, surgical, and individual risk factors are linked to PONV Studies in this field have identified several predicting risk factors for PONV .

Apfel et al established a validated simplified scoring systems to assess risk factors for nausea and vomiting after general anesthesia. His simplified sum score system included four risk factors: female gender, prior history of motion sickness or PONV, nonsmoking, and the use of postoperative opioids .

If none or only one risk factor is present the predicted incidence of PONV may vary between about 10% and 21%, whereas if at least two risk factors are present it increases to between 39% and 78%.

To date research has yet to yield a predictive model for neuraxial morphine induced nausea and vomiting (NMINV). Likewise risk factor for neuraxial itching have yet to be established.

Methods This is a prospective, single center study, which will be conducted at the Rabin Medical Center (Beilinson Campus), Petach Tikva, Israel, a tertiary university hospital. The Institutional Review Board has approved this study.

All women undergoing cesarean section delivery under spinal anesthesia with neuraxial morphine will be enrolled after filling out an informed consent prior to surgery. Women undergo spinal anesthesia with 10-12 mg heavy bupivicaine, 20 ucg fentanyl and 100 ucg morphine. Phenylepherine drip is used at anesthesiologist's discretion. If not treatment dose of ephedrine or phenylepherine are given as required by blood pressure.

All women receive prophylaxis intravenous dexamenthasone 4 mg and prophylactic intravenous ondansetron 4mg, as standard departmental protocol.

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).

Nausea includes any feeling of sickness with an inclination to vomit. Retching includes any reverse movement of the stomach and esophagus without vomiting, including attempting vomiting.

Vomiting is defined as the involuntary, forceful expulsion of one's gastric contents through the mouth and sometimes the nose.

A VNRS (vas numerical rating score) (from 0-10 0= no itching at all , 10= worst itching possible) will be used to measure overall presence and severity of pruritus.

Any severe incidence of VNRS defined above 7 will be noted. All parturients need for postoperative antiemetic and antipruritic medications will be reported.

Being tested
Questionaire
Medical subject headings
Postoperative Nausea and Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QuestionaireOther

    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).

Study groups in NCT03178058
Study groupRoleWhat they receive
Parturients for CSParturients 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).
Receives: Other: Questionaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Demographic causative factors for postoperative nausea after administration of neuraxial morphine

    Demographic factors that contribute to postoperative nausea after administration of neuraxial morphine as measured by the PONV questionnaire

    Measured: 24 Hours

Secondary outcomes (2)
  1. Demographic causative factors for postoperative vomiting after administration of neuraxial morphine

    emographic factors that contribute to postoperative vomiting after administration of neuraxial morphine as measured by the PONV questionnaire

    Measured: 24 hours

  2. Demographic causative factors for postoperative pruritus after administration of neuraxial morphine

    Demographic factors that contribute to postoperative pruritus after administration of neuraxial morphine as measured by the PONV questionnaire

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2017
  2. Study startOct 2016
  3. Primary completionOct 2017 (estimated)
  4. Study completionDec 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03178058
Sponsor's protocol ID
0387-15
Status last verified
Jun 2017
First submitted
9 May 2017
Last updated
6 Jun 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Postoperative Nausea and Vomiting, run by Rabin Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Demographic causative factors for postoperative nausea after administration of neuraxial morphine (time frame: 24 Hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2017.

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