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

NCT ID: NCT02143128

Last Updated: 2023-09-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomized trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Efficacy Safety Score

Patients assessed using the ESS

Group Type EXPERIMENTAL

Efficacy Safety Score

Intervention Type OTHER

Evaluation using the score for postoperative patients

Verbal Numeric Rating Scale

Patients assessed using VNRS

Group Type ACTIVE_COMPARATOR

Verbal Numeric Rating Scale

Intervention Type OTHER

Patients assessed for postoperative pain using VNRS (0-10)

Control

Regular follow up

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Efficacy Safety Score

Evaluation using the score for postoperative patients

Intervention Type OTHER

Verbal Numeric Rating Scale

Patients assessed for postoperative pain using VNRS (0-10)

Intervention Type OTHER

Other Intervention Names

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ESS VNRS

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Norwegian Medical Association

OTHER

Sponsor Role collaborator

Vestre VikenHF Kongsberg Sykehus

OTHER

Sponsor Role lead

Responsible Party

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Erlend Johan Skraastad

Consultant, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vladimir Kuklin, Dr med

Role: PRINCIPAL_INVESTIGATOR

Vestre VIkenHF, Kongsberg

Locations

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Astana University Hospital, Astana

Astana, , Kazakhstan

Site Status

Krasnodar University Hospital

Krasnodar, , Russia

Site Status

Countries

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Kazakhstan Russia

References

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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.

Reference Type DERIVED
PMID: 28855800 (View on PubMed)

Other Identifiers

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VVHF-KS001

Identifier Type: -

Identifier Source: org_study_id

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