Do we Achieve the Goal of "No Worse Than Mild Pain" in Daily Clinical Practice?
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Observational

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.
    

Intervention name(s): no intervention will take place
Intervention type(s): Other
Intervention description(s): 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
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing a relevant surgical intervention at Zealand University Hospital, Koege
        and meeting the inclusion criteria
      
Keywords: individual patient