Postoperative PainESScoreNCT02143128
Efficacy Side-effect Score (ESS): Development and Evaluation of a New Tool for Patients After Surgery
A study testing Efficacy Safety Score and Verbal Numeric Rating Scale in people with Postoperative Pain and Postoperative Vomiting and Nausea, run by Vestre VikenHF Kongsberg Sykehus at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Postoperative Vomiting and Nausea, Postoperative Complications
- What is being tested?
- Efficacy Safety Score and Verbal Numeric Rating Scale
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,152 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2014to May 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All adult postoperative patients that are inpatients, and scheduled for hospitalization for more than 8 hours
Who cannot join
- Children, mental illness, communication difficulties
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Safety and Quality for Inpatients After Surgery at the Ward. Development and Evaluation of a New Tool: Efficacy Side-effect Score (ESS)
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.
Read the 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.
- Conditions
- Postoperative Pain, Postoperative Vomiting and Nausea, Postoperative Complications, Mental Status Changes Postoperative
- Being tested
- Efficacy Safety Score, Verbal Numeric Rating Scale
- Keywords
- score, postoperative, pain, nausea, mental status, tool
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting, Postoperative Complications, Pain, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efficacy Safety ScoreOther
Also called ESS
Evaluation using the score for postoperative patients
Verbal Numeric Rating ScaleOther
Also called VNRS
Patients assessed for postoperative pain using VNRS (0-10)
| Study group | Role | What they receive |
|---|---|---|
| Efficacy Safety Score | Experimental | Patients assessed using the ESS Receives: Other: Efficacy Safety Score |
| Verbal Numeric Rating Scale | Active comparator | Patients assessed using VNRS Receives: Other: Verbal Numeric Rating Scale |
| Control | No intervention | Regular follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Hospital Stay (LOS)
Assess LOS in groups of patients with different types of clinical data records an "all-out algorithms"
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study startMar 2014
- Primary completionApr 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized trial
- Masking
- None (open label)
- Enrolment
- 1,152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vestre VikenHF Kongsberg Sykehus
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Medical Association
- Responsible party
- Principal investigator, Erlend Johan Skraastad, Vestre VikenHF Kongsberg Sykehus
- Investigators
- Vladimir Kuklin, Dr med, Principal investigator, Vestre VIkenHF, Kongsberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02143128
- Sponsor's protocol ID
- VVHF-KS001
- Acronym
- ESScore
- Status last verified
- Sep 2023
- First submitted
- 14 May 2014
- Last updated
- 11 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: On reasonable request
Publications
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.
PubMed 28855800
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Quality for Inpatients After Surgery at the Ward. Development and Evaluation of a New Tool: Efficacy Side-effect Score (ESS)
- ClinicalTrials.gov ID
- NCT02143128
- Acronym / sponsor ID
- ESScore / VVHF-KS001
- Conditions
- Postoperative Pain, Postoperative Vomiting and Nausea, Postoperative Complications, Mental Status Changes Postoperative
- Keywords
- score, postoperative, pain, nausea, mental status, tool
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,152 participants (actual)
- Lead sponsor
- Vestre VikenHF Kongsberg SykehusUniversity, hospital or other
- Collaborators
- Norwegian Medical Association
- Study start
- Mar 2014 (actual)
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 20 May 2014 (estimated)
- Results
- Posted 11 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Prospective randomized trial
| Arm | Type | Receives |
|---|---|---|
| Efficacy Safety Score | Experimental | Other: Efficacy Safety ScorePatients assessed using the ESS |
| Verbal Numeric Rating Scale | Active comparator | Other: Verbal Numeric Rating ScalePatients assessed using VNRS |
| Control | No intervention | –Regular follow up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult postoperative patients that are inpatients, and scheduled for hospitalization for more than 8 hours
Key exclusion criteria (1 listed)
- Children, mental illness, communication difficulties
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Efficacy Safety ScoreAlso: ESSEvaluation using the score for postoperative patients | Other | Efficacy Safety Score |
| Verbal Numeric Rating ScaleAlso: VNRSPatients assessed for postoperative pain using VNRS (0-10) | Other | Verbal Numeric Rating Scale |
Primary outcome
Length of Hospital Stay (LOS)
Time frame: 28 days
Assess LOS in groups of patients with different types of clinical data records an "all-out algorithms"
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28855800Dybvik 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.
- Individual participant dataSharing planned: Yes. On reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vladimir Kuklin, Dr med principal investigator
Vestre VIkenHF, Kongsberg
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Efficacy Safety Score and Verbal Numeric Rating Scale in people with Postoperative Pain and Postoperative Vomiting and Nausea, run by Vestre VikenHF Kongsberg Sykehus at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Kazakhstan, Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Hospital Stay (LOS) (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02143128, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2023.