Efficacy Safety Score in Postoperative Management

Pain, Postoperative Clinical Trial

Official title:

Use of Efficacy Safety Score in Postoperative Management: A Prospective, Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03438578
• Other study ID #: 2017/1903
• Status: Completed
• Phase: N/A
• Start date: March 5, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: September 2020
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary aim of this project is to determine whether postoperative patients may benefit from the Efficacy Safety Score (ESS) as a tool for postoperative clinical decision support, with a special focus on the first 24 hours after discharge from the postoperative care unit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 1, 2019
• Est. primary completion date: October 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• undergoing surgery

• expectedly to be treated and observed in hospital for more than 24 hours postoperatively

Exclusion Criteria:

• refusal of participation

• poor communication capabilities

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Device:
• Efficacy Safety Score monitoring
According to data gathered from ESS and monitoring, the patients will receive needed care.

Locations

Country	Name	City	State
Norway	St Olav University Hospital	Orkdal

Sponsors (2)

Lead Sponsor	Collaborator
St. Olavs Hospital	Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Skraastad EJ, Borchgrevink PC, Nilsen TIL, Raeder J. Postoperative quality and safety using Efficacy Safety Score (ESS) and a wireless patient monitoring system at the ward: A randomised controlled study. Acta Anaesthesiol Scand. 2020 Mar;64(3):301-308. d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Mobilization	The measured postoperative time when patient can stand and able to walk one or more steps, with or without support	24 hours
Secondary	Pain Measurement, Verbal Numeric Rating Scale	Reported pain hourly on a 11-digit scale, called Verbal Numeric Rating Scale for pain, 0-10 where 0 is no pain, and 10 is worst thinkable pain. Higher scores mean a worse outcome.	24 hours
Secondary	Patient Satisfaction	Reported patient satisfaction on a 1-5 scale, (Likert scale), where 1 is Very dissatisfied, and 5 is Very satisfied. Higher scores mean a better outcome.	24 hours