Efficacy Side-effect Score (ESS): Development and Evaluation of a New Tool for Patients After Surgery

Not Applicable

Completed

• Conditions: Postoperative Pain; Postoperative Vomiting and Nausea; Mental Status Changes Postoperative; Postoperative Complications
• Interventions: Other: Efficacy Safety Score; Other: Verbal Numeric Rating Scale

• Registration Number: NCT02143128
• Lead Sponsor: Vestre VikenHF Kongsberg Sykehus

Brief Summary

We hypothesized that better control of postoperative pain treatment and its side effects by monitoring ESS might influence the degree of mobility and morbidity in surgical patients and consequently reduce LOS. Thus, our aim was to validate the influence of recording ESS and the application of a "call-out algorithm" on LOS in two university hospitals in which the routine policy of registration of pain had not been adopted yet.

Detailed Description

Using clinical experience and consensus-methodology the investigators picked up and digitalized information about mental, postoperative nausea, vomiting and pain status at the rest and during mobilization in so called Efficacy Safety Score (ESS). Depending on expression of patient's complaints, all mentioned above clinical features are scored. We hypothesized that better control of postoperative pain treatment and its side effects by monitoring ESS might influence the degree of mobility and morbidity in surgical patients and consequently reduce length of hospital stay (LOS). Thus, our aim was to validate the influence of recording ESS and the application of a "call-out algorithm" on LOS in two university hospitals in which the routine policy of registration of pain had not been adopted yet. The primary endpoint of the study was to assess LOS in groups of patients with different types of clinical data records and "call-out algorithms," while secondary endpoints were to compare the degree of mobilization, number of postoperative nonsurgical complications, and 28-day survival between the groups.and summarized in the total score.

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-05-14
• Study First Submitted QC: 2014-05-16
• Study First Posted: 2014-05-20
• Primary Completion: 2015-04
• Study Completion: 2015-05
• Results First Submitted: 2022-10-26
• Status Verified: 2023-09
• Results First Submitted QC: 2023-09-08
• Last Update Submitted: 2023-09-08
• Results First Posted: 2023-09-11
• Last Update Posted: 2023-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1152

Inclusion Criteria

• All adult postoperative patients that are inpatients, and scheduled for hospitalization for more than 8 hours

Exclusion Criteria

• Children, mental illness, communication difficulties

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Efficacy Safety Score	Efficacy Safety Score	Patients assessed using the ESS
Verbal Numeric Rating Scale	Verbal Numeric Rating Scale	Patients assessed using VNRS

Primary Outcome Measures

Name	Time	Method
Length of Hospital Stay (LOS)	28 days	Assess LOS in groups of patients with different types of clinical data records an "all-out algorithms"

Trial Locations

Locations (2)

Krasnodar University Hospital; 🇷🇺 Krasnodar, Russian Federation

Astana University Hospital, Astana; 🇰🇿 Astana, Kazakhstan