Do we Achieve the Goal of No Worse Than Mild Pain in Daily Clinical Practice?

Study Overview
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Brief Summary
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With this study the investigators want to perform a prospective cross-sectional audit at Zealand University Hospital, Koege, Denmark. The aim is to investigate the actual pain treatment and outcomes from a representative number of surgical procedures from different surgical departments.

Detailed Description
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In contemporary postoperative pain management, patients are treated with combinations of non-opioid and opioid analgesics, and analgesic methods. The intention is to enhance pain relief from additive or synergistic effects of such combinations. However, the literature is complex and heterogenic and characterized by small sized studies investigating a diversity of analgesic combinations and methods. Consequently no well-documented best current proven intervention is definable Efficacy of analgesics is most often based on results from randomized trials measuring differences between two groups based on the average pain level in each group, for example median or mean. This approach has weaknesses as individual patients vary in response, and the average pain level is actually only experienced by few patients. Also, it is well known that analgesics may only work in 30- 50% of the patients and it is not possible to predict who will experience excessive pain. Besides, data on pain score does not follow a normal distribution, but usually is either very good or very bad. Studies have demonstrated, that basically, patients want efficient pain treatment with large pain reductions (for example 50%) and/or pain levels corresponding to mild pain, Numeric Rating Scale ≤ 3. Pain treatment that does not include the achievement of adequate pain relief are likely to fail. Consequently, a new and simple universal criterion for postoperative analgesic success has been suggested based on individual patient response analyses: Efficacy should be measured on the individual level, and patients should experience no worse than mild pain(Numeric Rating Scale ≤ 3). In a re-calculation of individual patient data from 16 randomized clinical trials, the investigators have recently documented that by using the success criteria that at least 80% of patients should achieve Visual Analogue Scale ≤ 30, only about 50% of the studies had achieved goal fulfillment. A current review has further documented, that movement evoked pain is underreported. Only 39% of trials measured movement evoked pain even though trials measuring both movement evoked pain and pain at rest suggest that movement evoked pain is 95% - 226% more severe and intense for the patient than pain at rest. Therefore it is of great importance for the benefits and treatment of patients, that future trials not only record pain at rest but also movement evoked pain, and additionally supply relevant information about the actual physical maneuver used for assessment. It is therefore essential, in the light of no worse than mild pain, and based on individual responder analysis, to investigate current benefit and harm of postoperative pain treatment. Our goal is to highlight the need for an intensified focus on individual patient's pain and the investigators expect to shed a new and critical light on current clinical pain treatment.

Official Title
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The Goal of no Worse Than Mild Pain in Daily Clinical Practice: Individual Responder Analysis - a Cross-sectional Prospective Cohort Study of Surgical Patients at Zealand University Hospital, Koege

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Other: no intervention will take place


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must meet all the following criteria to be suitable for inclusion in the study Age > 18 år Patients scheduled for relevant surgical procedure Patients who understand and speak Danish or English - Exclusion Criteria: Patients who meet one or more of the following criteria are not suitable for inclusion in this study: Patients who cannot cooperate Alcohol and drug dependency as judged by the investigator Chronic opioid dependent patients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Spinal Surgery<br>No intervention will take place. Recruiting Autumn 2017 until spring 2018 | Other: no intervention will take place<br>* Only registration and data collection of patients' care and treatment will take place. There will be no changes in patients' treatment. No intervention will take place<br>|
| Gastric sleeve<br>No intervention will take place. Recruiting Autumn 2017 until spring 2018 | Other: no intervention will take place<br>* Only registration and data collection of patients' care and treatment will take place. There will be no changes in patients' treatment. No intervention will take place<br>|
| Total knee arthroplasty<br>No intervention will take place. Recruiting Spring 2018 until Summer 2018 | Other: no intervention will take place<br>* Only registration and data collection of patients' care and treatment will take place. There will be no changes in patients' treatment. No intervention will take place<br>|
| Shoulder arthroplasty<br>No intervention will take place. Recruiting Winter 2017 until Summer 2018 | Other: no intervention will take place<br>* Only registration and data collection of patients' care and treatment will take place. There will be no changes in patients' treatment. No intervention will take place<br>|
| Maxillofacial surgery<br>No intervention will take place. Recruiting 6 march 2017 until Autumn 2017 | Other: no intervention will take place<br>* Only registration and data collection of patients' care and treatment will take place. There will be no changes in patients' treatment. No intervention will take place<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain during mobilisation late | Proportions achieving no worse than mild pain (Numeric Rating Scale ≤ 3) for pain during mobilisation at 24 hours (±2h) postoperatively | Outcome measure will be assessed and data will be presented in june 2018 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain during mobilisation early | Proportions achieving no worse than mild pain (Numeric Rating Scale ≤ 3) during mobilisation at 6 hours (±2h) postoperatively | Outcome measure will be assessed and data will be presented in june 2018 | 
| Pain at rest early | Proportions achieving no worse than mild pain (Numeric Rating Scale ≤ 3) at rest at 6h (±2h) and 24h (±2h) postoperatively | Outcome measure will be assessed and data will be presented in june 2018 | 
| Numeric Rating Scale pain levels | Numeric Rating Scale pain levels at rest and during mobilisation at 6h (±2h) and 24h (±2h) after completed surgery 6 and 24 hours | Outcome measure will be assessed and data will be presented in june 2018 | 
| Patient satisfaction | Patients' experience of pain treatment and their contentment hereof using a questionnaire based on PAIN OUT at 24h (±2h) postoperatively | Outcome measure will be assessed and data will be presented in june 2018 | 
| Morphine consumption | Morphine i.v. equivalent consumption (mg) the first 24h postoperatively (including opioids given as pre-medication | Outcome measure will be assessed and data will be presented in june 2018 | 
| Non opioid use | Non-opioid analgesic usage the first 24h postoperatively (including non-opioids given as pre-medication) | Outcome measure will be assessed and data will be presented in june 2018 | 
| Nausea | Nausea measured by Verbal Rating Scale at T6 og T24 hours postoperatively | Outcome measure will be assessed and data will be presented in june 2018 | 
| Vomiting | Vomiting (number of episodes 0-24 hours) postoperatively | Outcome measure will be assessed and data will be presented in june 2018 | 
| Dizziness | Dizziness measured by Verbal Rating Scale at T6 and T24 hours | Outcome measure will be assessed and data will be presented in june 2018 | 
| Sedation | Sedation measured by Verbal Rating Scale at T6 og T24 hours postoperatively | Outcome measure will be assessed and data will be presented in june 2018 | 
| LOS | Length of postoperative hospital stay measured in days | Outcome measure will be assessed and data will be presented in june 2018 | 
| Readmission | Re-admission within 90 days postoperatively | Outcome measure will be assessed and data will be presented in june 2018 | 
| Mortality | Mortality within the first 90 days | Outcome measure will be assessed and data will be presented in june 2018 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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individual patient