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

Postoperative Pain Clinical Trial

— ESScore  

Official title:

Safety and Quality for Inpatients After Surgery at the Ward. Development and Evaluation of a New Tool: Efficacy Side-effect Score (ESS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02143128
• Other study ID #: VVHF-KS001
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: May 2015

Study information

• Verified date: September 2023
• Source: Vestre VikenHF Kongsberg Sykehus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1152
• Est. completion date: May 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Status Changes Postoperative
• Nausea
• Postoperative Complications
• Postoperative Nausea and Vomiting
• Postoperative Pain
• Postoperative Vomiting and Nausea
• Vomiting

Intervention

Other:
• Efficacy Safety Score
Evaluation using the score for postoperative patients
• Verbal Numeric Rating Scale
Patients assessed for postoperative pain using VNRS (0-10)

Locations

Country	Name	City	State
Kazakhstan	Astana University Hospital, Astana	Astana
Russian Federation	Krasnodar University Hospital	Krasnodar

Sponsors (2)

Lead Sponsor	Collaborator
Vestre VikenHF Kongsberg Sykehus	Norwegian Medical Association

Countries where clinical trial is conducted

Kazakhstan,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of Hospital Stay (LOS)	Assess LOS in groups of patients with different types of clinical data records an "all-out algorithms"	28 days