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Incidence and Factors Associated With PONV in Regional Anaesthesia

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ClinicalTrials.gov Identifier: NCT03835234
Recruitment Status : Recruiting
First Posted : February 8, 2019
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
Makerere University

Brief 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. 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.

Condition or disease
PONV

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.


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Study Type : Observational
Estimated Enrollment : 364 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Incidence of and Factors Associated With Post-operative Nausea and Vomiting Following Surgery Under Regional Anaesthesia
Actual Study Start Date : September 10, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. nausea and vomiting after 24hours using apfel score [ Time Frame: 24 hours ]
    Any retching, nausea or vomiting within 24 hours following surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.

Criteria

Inclusion Criteria:

  • Patients undergoing regional anaesthesia for emergency or elective surgery.
  • Patients aged 18 years and above.
  • ASA class 1, 2, 3 and 4 patients

Exclusion Criteria:

  • Patients who are switched to general anaesthesia after planned regional anaesthesia.
  • Patients with pre-existing nausea and vomiting from co-morbidities.

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): NCT03835234


Contacts
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Contact: Dorothy Turitwenka, MBchB 0759889087 ext 256 dorothy.turitwenka@gmail.com

Locations
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Uganda
Mulago hospital Recruiting
Kampala, Uganda, 256
Contact: Ponsiano Ocama, PHD    0772421190 ext 256      
Sponsors and Collaborators
Makerere University
Investigators
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Principal Investigator: Dorothy Turitwenka Makerere University

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Responsible Party: Makerere University
ClinicalTrials.gov Identifier: NCT03835234     History of Changes
Other Study ID Numbers: PONVRA
First Posted: February 8, 2019    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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