Do we Achieve the Goal of "No Worse Than Mild Pain" in Daily Clinical Practice?
- Conditions
- Pain, Postoperative
- Interventions
- Other: no intervention will take place
- Registration Number
- NCT03080272
- Lead Sponsor
- Zealand University Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 190
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 -
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Spinal Surgery no intervention will take place No intervention will take place. Recruiting Autumn 2017 until spring 2018 Gastric sleeve no intervention will take place No intervention will take place. Recruiting Autumn 2017 until spring 2018 Maxillofacial surgery no intervention will take place No intervention will take place. Recruiting 6 march 2017 until Autumn 2017 Total knee arthroplasty no intervention will take place No intervention will take place. Recruiting Spring 2018 until Summer 2018 Shoulder arthroplasty no intervention will take place No intervention will take place. Recruiting Winter 2017 until Summer 2018
- Primary Outcome Measures
Name Time Method Pain during mobilisation late Outcome measure will be assessed and data will be presented in june 2018 Proportions achieving "no worse than mild pain" (Numeric Rating Scale ≤ 3) for pain during mobilisation at 24 hours (±2h) postoperatively
- Secondary Outcome Measures
Name Time Method Pain during mobilisation early Outcome measure will be assessed and data will be presented in june 2018 Proportions achieving "no worse than mild pain" (Numeric Rating Scale ≤ 3) during mobilisation at 6 hours (±2h) postoperatively
Pain at rest early Outcome measure will be assessed and data will be presented in june 2018 Proportions achieving "no worse than mild pain" (Numeric Rating Scale ≤ 3) at rest at 6h (±2h) and 24h (±2h) postoperatively
Non opioid use Outcome measure will be assessed and data will be presented in june 2018 Non-opioid analgesic usage the first 24h postoperatively (including non-opioids given as pre-medication)
Dizziness Outcome measure will be assessed and data will be presented in june 2018 Dizziness measured by Verbal Rating Scale at T6 and T24 hours
Sedation Outcome measure will be assessed and data will be presented in june 2018 Sedation measured by Verbal Rating Scale at T6 og T24 hours postoperatively
Readmission Outcome measure will be assessed and data will be presented in june 2018 Re-admission within 90 days postoperatively
Nausea Outcome measure will be assessed and data will be presented in june 2018 Nausea measured by Verbal Rating Scale at T6 og T24 hours postoperatively
Patient satisfaction Outcome measure will be assessed and data will be presented in june 2018 Patients' experience of pain treatment and their contentment hereof using a questionnaire based on "PAIN OUT" at 24h (±2h) postoperatively
Morphine consumption Outcome measure will be assessed and data will be presented in june 2018 Morphine i.v. equivalent consumption (mg) the first 24h postoperatively (including opioids given as pre-medication
Vomiting Outcome measure will be assessed and data will be presented in june 2018 Vomiting (number of episodes 0-24 hours) postoperatively
Mortality Outcome measure will be assessed and data will be presented in june 2018 Mortality within the first 90 days
Numeric Rating Scale pain levels Outcome measure will be assessed and data will be presented in june 2018 Numeric Rating Scale pain levels at rest and during mobilisation at 6h (±2h) and 24h (±2h) after completed surgery 6 and 24 hours
LOS Outcome measure will be assessed and data will be presented in june 2018 Length of postoperative hospital stay measured in days
Trial Locations
- Locations (1)
Zealand University Hospital
🇩🇰Køge, Zealand, Denmark