PONVNCT03835234
Incidence and Factors Associated With PONV in Regional Anaesthesia
An observational study of PONV and Regional Anaesthesia, run by Makerere University at 1 site in Uganda.
Trial summary
Post-operative nausea and vomiting (PONV) is one of the complications associated with surgery and anaesthesia. The main aim of the study is to determine the incidence of post-operative nausea and vomiting among surgical patients undergoing regional anaesthesia and the factors associated with it. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- PONV, Regional Anaesthesia
- How many people
- 364 participants
- Where
- 1 siteUganda
- Study dates
- 1 Aug 2018to 31 Jan 2019
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The target populations are all patients 18 years of age and above scheduled for an elective or emergency surgical procedure under regional anaesthesia at Mulago hospital. The accessible population includes all patients attending Mulago hospital for elective and emergency surgery under regional anaesthesia during the study period.
Who may be able to join
- Patients undergoing regional anaesthesia for emergency or elective surgery.
- Patients aged 18 years and above.
- ASA class 1, 2, 3 and 4 patients
Who cannot join
- Patients who are switched to general anaesthesia after planned regional anaesthesia.
- Patients with pre-existing nausea and vomiting from co-morbidities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence of and Factors Associated With Post-operative Nausea and Vomiting Following Surgery Under Regional Anaesthesia
Post-operative nausea and vomiting (PONV) is one of the complications associated with surgery and anaesthesia. The main aim of the study is to determine the incidence of post-operative nausea and vomiting among surgical patients undergoing regional anaesthesia and the factors associated with it. Patients above the age of 18 who have consented and are undergoing surgery under regional anaesthesia will be enrolled into the study over 6months. They will then be observed for up to 24 hours post operatively to determine the incidence of PONV and factors associated with it.
Read the detailed description
Post-operative nausea and vomiting (PONV) is one of the complications associated with surgery and anaesthesia. Due to advanced techniques in the field of anaesthesia and surgery, patients are commonly operated on under regional anaesthesia (RA) rather than general anaesthesia (GA). Post-operative nausea and vomiting (PONV) still occurs with regional anaesthesia, but the incidence and associated factors in our setting remain unknown. An optimal management of PONV is important because they can lead to increased morbidity.
The main aim of the study is to determine the incidence of post-operative nausea and vomiting among surgical patients undergoing regional anaesthesia and the factors associated with it.
This will be a prospective cohort study. Patients aged 18 years and above in whom surgery under regional anaesthesia is planned at Mulago hospital will be consented and enrolled into the study over 6months. Data will be collected using semi structured and pre-tested questionnaires. Patients will be observed for up to 24 hours post operatively to determine the incidence of and factors associated with PONV in regional anaesthesia at Mulago hospital. After recruitment, patients will be followed up once at 24 hours post-operatively.
Results from this study will determine the incidence of post-operative nausea and vomiting in surgical patients undergoing regional anaesthesia and the associated factors, data which we do not have in our setting. This will help to guide practice on the prevention and management of post-operative nausea and vomiting.
- Conditions
- PONV, Regional Anaesthesia
- Keywords
- PONV, Regional anaesthesia, LMIC
- Medical subject headings
- Postoperative Nausea and Vomiting
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of post operative nausea and vomiting following surgery under regional anaesthesia at Mulago hospital
Any retching, nausea or vomiting within 24 hours following surgery under regional anaesthesia in Mulago hospital
Measured: 24 hours
factors associated with post operative nausea and vomiting following surgery under anaesthesia at Mulago hospital using the Apfel score.
to determine factors associated with post operative nausea and vomiting following surgery under regional anaesthesia at Mulago hospital using the Apfel score.
The Apfel score is a verified risk score for predicting post operative nausea and vomiting.It describes four risk factors that when present are scored 1 point each and 0 points when absent. These four risk factors are: use of post operative opioids, female gender, non-smoking status and history of post operative nausea and vomiting or motion sickness. The highest possible score is 4 and lowest possible score is 0.
Measured: 24 hours
Secondary outcomes (1)
Proportion of patients that received prophylaxis against post operative nausea and vomiting during surgery under regional anaesthesia at Mulago hospital
Proportion of patients who received prophylaxis against post operative nausea and vomiting during surgery under regional anaesthesia at Mulago hospital
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 posted8 Feb 2019
- Study start1 Aug 2018
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PONVStudies 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
- 364 participants (actual)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dorothy Turitwenka, Principal investigator, Makerere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03835234
- Sponsor's protocol ID
- PONVRA
- Status last verified
- Aug 2024
- First submitted
- 11 Sep 2018
- Last updated
- 27 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of and Factors Associated With Post-operative Nausea and Vomiting Following Surgery Under Regional Anaesthesia
- ClinicalTrials.gov ID
- NCT03835234
- Acronym / sponsor ID
- PONVRA
- Conditions
- PONV, Regional Anaesthesia
- Keywords
- PONV, Regional anaesthesia, LMIC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 364 participants (actual)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 8 Feb 2019 (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.
Post-operative nausea and vomiting (PONV) is one of the complications associated with surgery and anaesthesia. The main aim of the study is to determine the incidence of post-operative nausea and vomiting among surgical patients undergoing regional anaesthesia and the factors associated with it. Patients above the age of 18 who have consented and are undergoing surgery under regional anaesthesia will be enrolled into the study over 6months. They will then be observed for up to 24 hours post operatively to determine the incidence of PONV and factors associated with it.
Detailed description
Post-operative nausea and vomiting (PONV) is one of the complications associated with surgery and anaesthesia. Due to advanced techniques in the field of anaesthesia and surgery, patients are commonly operated on under regional anaesthesia (RA) rather than general anaesthesia (GA). Post-operative nausea and vomiting (PONV) still occurs with regional anaesthesia, but the incidence and associated factors in our setting remain unknown. An optimal management of PONV is important because they can lead to increased morbidity.
The main aim of the study is to determine the incidence of post-operative nausea and vomiting among surgical patients undergoing regional anaesthesia and the factors associated with it.
This will be a prospective cohort study. Patients aged 18 years and above in whom surgery under regional anaesthesia is planned at Mulago hospital will be consented and enrolled into the study over 6months. Data will be collected using semi structured and pre-tested questionnaires. Patients will be observed for up to 24 hours post operatively to determine the incidence of and factors associated with PONV in regional anaesthesia at Mulago hospital. After recruitment, patients will be followed up once at 24 hours post-operatively.
Results from this study will determine the incidence of post-operative nausea and vomiting in surgical patients undergoing regional anaesthesia and the associated factors, data which we do not have in our setting. This will help to guide practice on the prevention and management of post-operative nausea and vomiting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The target populations are all patients 18 years of age and above scheduled for an elective or emergency surgical procedure under regional anaesthesia at Mulago hospital. The accessible population includes all patients attending Mulago hospital for elective and emergency surgery under regional anaesthesia during the study period.
Key inclusion criteria (3 listed)
- Patients undergoing regional anaesthesia for emergency or elective surgery.
- Patients aged 18 years and above.
- ASA class 1, 2, 3 and 4 patients
Key exclusion criteria (2 listed)
- Patients who are switched to general anaesthesia after planned regional anaesthesia.
- Patients with pre-existing nausea and vomiting from co-morbidities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
incidence of post operative nausea and vomiting following surgery under regional anaesthesia at Mulago hospital
Time frame: 24 hours
Any retching, nausea or vomiting within 24 hours following surgery under regional anaesthesia in Mulago hospital
factors associated with post operative nausea and vomiting following surgery under anaesthesia at Mulago hospital using the Apfel score.
Time frame: 24 hours
to determine factors associated with post operative nausea and vomiting following surgery under regional anaesthesia at Mulago hospital using the Apfel score. The Apfel score is a verified risk score for predicting post operative nausea and vomiting.It describes four risk factors that when present are scored 1 point each and 0 points when absent. These four risk factors are: use of post operative opioids, female gender, non-smoking status and history of post operative nausea and vomiting or motion sickness. The highest possible score is 4 and lowest possible score is 0.
1 secondary outcome
Proportion of patients that received prophylaxis against post operative nausea and vomiting during surgery under regional anaesthesia at Mulago hospital
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for PONV
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Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
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A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
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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.
Dorothy Turitwenka principal investigator
Makerere University
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 PONV and Regional Anaesthesia, run by Makerere University at 1 site in Uganda.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 27 Aug 2024. 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 Uganda. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of post operative nausea and vomiting following surgery under regional anaesthesia at Mulago hospital (time frame: 24 hours). The study lists 2 primary outcomes in all. 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 27 Aug 2024.