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.
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
- Recruiting
Beilinson hospital
Petach Tikvah
Sharon Orbach, MD, 972-54-538-3093, sharonorbach@yahoo.com
Sharon Orbach-zinger
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.
- Conditions
- Postoperative Nausea and Vomiting
- 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 group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Questionaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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.
- First posted6 Jun 2017
- Study startOct 2016
- Primary completionOct 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sharon orbach, Rabin Medical Center
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Nausea, Vomiting and Pruritus After Neuraxial Morphine for Cesarean Section
- ClinicalTrials.gov ID
- NCT03178058
- Acronym / sponsor ID
- 0387-15
- Conditions
- Postoperative Nausea and Vomiting
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 6 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parturients for CS | – | Other: QuestionaireParturients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionairePrior 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 | Parturients for CS |
Primary outcome
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
2 secondary outcomes
Demographic causative factors for postoperative vomiting after administration of neuraxial morphine
Time frame: 24 hours
Demographic causative factors for postoperative pruritus after administration of neuraxial morphine
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.