Mental Status Changes Postoperative, Postoperative Complications, Postoperative Pain, Postoperative Vomiting and Nausea
Conditions
Keywords
score, postoperative, pain, nausea, mental status, tool
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.
Interventions
OTHEREfficacy Safety Score
Evaluation using the score for postoperative patients
OTHERVerbal Numeric Rating Scale
Patients assessed for postoperative pain using VNRS (0-10)
Sponsors
Norwegian Medical Association
Vestre VikenHF Kongsberg Sykehus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Prospective randomized trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of Hospital Stay (LOS) | 28 days | Assess LOS in groups of patients with different types of clinical data records an all-out algorithms |
Countries
Kazakhstan, Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Efficacy Safety Score Patients assessed using the ESS
Efficacy Safety Score: Evaluation using the score for postoperative patients | 409 |
| Verbal Numeric Rating Scale Patients assessed using VNRS
Verbal Numeric Rating Scale: Patients assessed for postoperative pain using VNRS (0-10) | 417 |
| Control Regular follow up | 326 |
| Total | 1,152 |
Baseline characteristics
| Characteristic | Efficacy Safety Score | Verbal Numeric Rating Scale | Control | Total |
|---|---|---|---|---|
| Age, Continuous Astana | 43.4 years STANDARD_DEVIATION 16.4 | 42.4 years STANDARD_DEVIATION 16.4 | 44.9 years STANDARD_DEVIATION 15.8 | 43.6 years STANDARD_DEVIATION 16.2 |
| Age, Continuous Krasnodar | 55.2 years STANDARD_DEVIATION 14.7 | 55.1 years STANDARD_DEVIATION 15.6 | 56 years STANDARD_DEVIATION 14.9 | 55.4 years STANDARD_DEVIATION 15.1 |
| Region of Enrollment Kazakhstan | 228 participants | 227 participants | 224 participants | 679 participants |
| Region of Enrollment Russia | 181 participants | 190 participants | 102 participants | 473 participants |
| Sex: Female, Male Kazakhstan, Astana Female | 112 Participants | 95 Participants | 104 Participants | 311 Participants |
| Sex: Female, Male Kazakhstan, Astana Male | 116 Participants | 132 Participants | 120 Participants | 368 Participants |
| Sex: Female, Male Russia, Krasnodar Female | 112 Participants | 121 Participants | 53 Participants | 286 Participants |
| Sex: Female, Male Russia, Krasnodar Male | 69 Participants | 69 Participants | 49 Participants | 187 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 409 | 0 / 417 | 0 / 326 |
| serious Total, serious adverse events | 0 / 409 | 0 / 417 | 0 / 326 |
Outcome results
Primary
Length of Hospital Stay (LOS)
Assess LOS in groups of patients with different types of clinical data records an all-out algorithms
Time frame: 28 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Efficacy Safety Score | Length of Hospital Stay (LOS) | 12.7 days |
| Verbal Numeric Rating Scale | Length of Hospital Stay (LOS) | 13.5 days |
| Control | Length of Hospital Stay (LOS) | 14.2 days |