<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03835234</url>
  </required_header>
  <id_info>
    <org_study_id>PONVRA</org_study_id>
    <nct_id>NCT03835234</nct_id>
  </id_info>
  <brief_title>Incidence and Factors Associated With PONV in Regional Anaesthesia</brief_title>
  <official_title>Incidence of and Factors Associated With Post-operative Nausea and Vomiting Following Surgery Under Regional Anaesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Makerere University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Makerere University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Post-operative nausea and vomiting (PONV) is one of the complications associated with surgery&#xD;
      and anaesthesia. The main aim of the study is to determine the incidence of post-operative&#xD;
      nausea and vomiting among surgical patients undergoing regional anaesthesia and the factors&#xD;
      associated with it. Patients above the age of 18 who have consented and are undergoing&#xD;
      surgery under regional anaesthesia will be enrolled into the study over 6months. They will&#xD;
      then be observed for up to 24 hours post operatively to determine the incidence of PONV and&#xD;
      factors associated with it.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Post-operative nausea and vomiting (PONV) is one of the complications associated with surgery&#xD;
      and anaesthesia. Due to advanced techniques in the field of anaesthesia and surgery, patients&#xD;
      are commonly operated on under regional anaesthesia (RA) rather than general anaesthesia&#xD;
      (GA). Post-operative nausea and vomiting (PONV) still occurs with regional anaesthesia, but&#xD;
      the incidence and associated factors in our setting remain unknown. An optimal management of&#xD;
      PONV is important because they can lead to increased morbidity.&#xD;
&#xD;
      The main aim of the study is to determine the incidence of post-operative nausea and vomiting&#xD;
      among surgical patients undergoing regional anaesthesia and the factors associated with it.&#xD;
&#xD;
      This will be a prospective cohort study. Patients aged 18 years and above in whom surgery&#xD;
      under regional anaesthesia is planned at Mulago hospital will be consented and enrolled into&#xD;
      the study over 6months. Data will be collected using semi structured and pre-tested&#xD;
      questionnaires. Patients will be observed for up to 24 hours post operatively to determine&#xD;
      the incidence of and factors associated with PONV in regional anaesthesia at Mulago hospital.&#xD;
      After recruitment, patients will be followed up once at 24 hours post-operatively.&#xD;
&#xD;
      Results from this study will determine the incidence of post-operative nausea and vomiting in&#xD;
      surgical patients undergoing regional anaesthesia and the associated factors, data which we&#xD;
      do not have in our setting. This will help to guide practice on the prevention and management&#xD;
      of post-operative nausea and vomiting.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 10, 2018</start_date>
  <completion_date type="Anticipated">June 2019</completion_date>
  <primary_completion_date type="Anticipated">June 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>nausea and vomiting after 24hours using apfel score</measure>
    <time_frame>24 hours</time_frame>
    <description>Any retching, nausea or vomiting within 24 hours following surgery</description>
  </primary_outcome>
  <enrollment type="Anticipated">364</enrollment>
  <condition>PONV</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The target populations are all patients 18 years of age and above scheduled for an elective&#xD;
        or emergency surgical procedure under regional anaesthesia at Mulago hospital.&#xD;
&#xD;
        The accessible population includes all patients attending Mulago hospital for elective and&#xD;
        emergency surgery under regional anaesthesia during the study period.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing regional anaesthesia for emergency or elective surgery.&#xD;
&#xD;
          -  Patients aged 18 years and above.&#xD;
&#xD;
          -  ASA class 1, 2, 3 and 4 patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are switched to general anaesthesia after planned regional anaesthesia.&#xD;
&#xD;
          -  Patients with pre-existing nausea and vomiting from co-morbidities.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dorothy Turitwenka</last_name>
    <role>Principal Investigator</role>
    <affiliation>Makerere University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dorothy Turitwenka, MBchB</last_name>
    <phone>0759889087</phone>
    <phone_ext>256</phone_ext>
    <email>dorothy.turitwenka@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Mulago hospital</name>
      <address>
        <city>Kampala</city>
        <zip>256</zip>
        <country>Uganda</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ponsiano Ocama, PHD</last_name>
      <phone>0772421190</phone>
      <phone_ext>256</phone_ext>
    </contact>
  </location>
  <location_countries>
    <country>Uganda</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>September 11, 2018</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>February 7, 2019</last_update_submitted>
  <last_update_submitted_qc>February 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03835234
org study id: PONVRA
nct id: NCT03835234
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: nausea and vomiting after 24hours using apfel score
time frame: 24 hours
description: Any retching, nausea or vomiting within 24 hours following surgery
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Dorothy Turitwenka
role: Principal Investigator
affiliation: Makerere University
last name: Dorothy Turitwenka, MBchB
phone: 0759889087
phone ext: 256
email: dorothy.turitwenka@gmail.com
facility: 
status: Recruiting
contact: 
country: Uganda
responsible party type: Sponsor
sharing ipd: No