NCT02143128

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,152

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started Mar 2014

Typical duration for not_applicable postoperative-pain

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 20, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
8.4 years until next milestone

Results Posted

Study results publicly available

September 11, 2023

Completed
Last Updated

September 11, 2023

Status Verified

September 1, 2023

Enrollment Period

1.1 years

First QC Date

May 14, 2014

Results QC Date

October 26, 2022

Last Update Submit

September 8, 2023

Conditions

Postoperative PainPostoperative Vomiting and NauseaPostoperative ComplicationsMental Status Changes Postoperative

Keywords

scorepostoperativepainnauseamental statustool

Outcome Measures

Primary Outcomes (1)

  • Length of Hospital Stay (LOS)

    Assess LOS in groups of patients with different types of clinical data records an "all-out algorithms"

    28 days

Study Arms (3)

Efficacy Safety Score

EXPERIMENTAL

Patients assessed using the ESS

Other: Efficacy Safety Score

Verbal Numeric Rating Scale

ACTIVE COMPARATOR

Patients assessed using VNRS

Other: Verbal Numeric Rating Scale

Control

NO INTERVENTION

Regular follow up

Interventions

Efficacy Safety ScoreOTHER

Evaluation using the score for postoperative patients

Also known as: ESS
Efficacy Safety Score
Verbal Numeric Rating ScaleOTHER

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

Also known as: VNRS
Verbal Numeric Rating Scale

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Children, mental illness, communication difficulties

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Astana University Hospital, Astana

Astana, 01005, Kazakhstan

Location

Krasnodar University Hospital

Krasnodar, Russia

Location

Related Publications (1)

  • 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.

    PMID: 28855800DERIVED

MeSH Terms

Conditions

Pain, PostoperativePostoperative Nausea and VomitingPostoperative ComplicationsPainNausea

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and SymptomsSigns and Symptoms, DigestiveVomiting

Results Point of Contact

Title
Dr Vladimir Kuklin
Organization
Dept of Anaesthesia and Intensive Care, Akershus University Hospital, Norway
vkuklin@me.com
98838024

Study Officials

  • Vladimir Kuklin, Dr med

    Vestre VIkenHF, Kongsberg

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Prospective randomized trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant, MD

Study Record Dates

First Submitted

May 14, 2014

First Posted

May 20, 2014

Study Start

March 1, 2014

Primary Completion

April 1, 2015

Study Completion

May 1, 2015

Last Updated

September 11, 2023

Results First Posted

September 11, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share

On reasonable request

Shared Documents
SAP, CSR, ANALYTIC CODE
Time Frame
After end of study
Access Criteria
Contact PI, Vladimir Kuklin
More information

Locations

KA(1)RU(1)