Incidence and Factors Associated With PONV in Regional Anaesthesia

PONV Clinical Trial

Official title:

Incidence of and Factors Associated With Post-operative Nausea and Vomiting Following Surgery Under Regional Anaesthesia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03835234
• Other study ID #: PONVRA
• Status: Recruiting
• Start date: September 10, 2018
• Est. completion date: June 2019

Study information

• Verified date: February 2019
• Source: Makerere University
• Contact: Dorothy Turitwenka, MBchB
• Phone: 0759889087
• Email: dorothy.turitwenka[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 364
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• PONV
• Postoperative Nausea and Vomiting

Locations

Country	Name	City	State
Uganda	Mulago hospital	Kampala

Sponsors (1)

Lead Sponsor	Collaborator
Makerere University

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	nausea and vomiting after 24hours using apfel score	Any retching, nausea or vomiting within 24 hours following surgery	24 hours