Clinical trial NCT03835234: Incidence and Factors Associated With PONV in Regional Anaesthesia
Official title: Incidence of and Factors Associated With Post-operative Nausea and Vomiting Following Surgery Under Regional Anaesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PONV
Regional Anaesthesia
Keywords: PONV
Regional anaesthesia
LMIC
Lead sponsor: Makerere University
Sponsor class: OTHER
First posted: 2019-02-08
Enrollment: 364
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: incidence of post operative nausea and vomiting following surgery under regional anaesthesia at Mulago hospital
timeFrame: 24 hours
measure: factors associated with post operative nausea and vomiting following surgery under anaesthesia at Mulago hospital using the Apfel score.
timeFrame: 24 hours
Secondary outcomes:
measure: Proportion of patients that received prophylaxis against post operative nausea and vomiting during surgery under regional anaesthesia at Mulago hospital
timeFrame: 24 hours
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Mulago hospital
Study officials:
affiliation: Makerere University
name: Dorothy Turitwenka
role: PRINCIPAL_INVESTIGATOR
References: