Clinical trial NCT02143128: Efficacy Side-effect Score (ESS): Development and Evaluation of a New Tool for Patients After Surgery
Official title: Safety and Quality for Inpatients After Surgery at the Ward. Development and Evaluation of a New Tool: Efficacy Side-effect Score (ESS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Postoperative Vomiting and Nausea
Postoperative Complications
Mental Status Changes Postoperative
Keywords: score
postoperative
pain
nausea
mental status
tool
Lead sponsor: Vestre VikenHF Kongsberg Sykehus
Sponsor class: OTHER
Collaborators: name: Norwegian Medical Association
First posted: 2014-05-20
Enrollment: 1152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized trial
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Length of Hospital Stay (LOS)
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Astana
country: Kazakhstan
facility: Astana University Hospital, Astana
city: Krasnodar
country: Russian Federation
facility: Krasnodar University Hospital
Study officials:
affiliation: Vestre VIkenHF, Kongsberg
name: Vladimir Kuklin, Dr med
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dybvik L, Skraastad E, Yeltayeva A, Konkayev A, Musaeva T, Zabolotskikh I, Bjertnaes L, Dahl V, Raeder J, Kuklin V. Influence of a New "Call-Out Algorithm" for Management of Postoperative Pain and Its Side Effects on Length of Stay in Hospital: A Two-Centre Prospective Randomized Trial. Pain Res Manag. 2017;2017:9431984. doi: 10.1155/2017/9431984. Epub 2017 Aug 10.