Incidence and Factors Associated With PONV in Regional Anaesthesia

NCT03835234 | Completed

• 1 other identifier: PONVRA
• Study Type: observational
• Target: 364
• Locations: 1 country
• Sites: 1

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.

Conditions

PONV; Regional Anaesthesia

Keywords

PONV; Regional anaesthesia; LMIC

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  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

  24 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Makerere University: lead

Study Sites (1)

Mulago hospital

Kampala, 256, Uganda

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Study Officials

• Dorothy Turitwenka

  Makerere University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: February 8, 2019
• Study Start: August 1, 2018
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)