Clinical trial NCT03080272: Do we Achieve the Goal of "No Worse Than Mild Pain" in Daily Clinical Practice?
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Postoperative
Keywords: individual patient
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2017-03-15
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain during mobilisation late
timeFrame: Outcome measure will be assessed and data will be presented in june 2018
Secondary outcomes:
measure: Pain during mobilisation early
timeFrame: Outcome measure will be assessed and data will be presented in june 2018
measure: Pain at rest early
timeFrame: Outcome measure will be assessed and data will be presented in june 2018
measure: Numeric Rating Scale pain levels
timeFrame: Outcome measure will be assessed and data will be presented in june 2018
measure: Patient satisfaction
timeFrame: Outcome measure will be assessed and data will be presented in june 2018
measure: Morphine consumption
timeFrame: Outcome measure will be assessed and data will be presented in june 2018
measure: Non opioid use
timeFrame: Outcome measure will be assessed and data will be presented in june 2018
measure: Nausea
timeFrame: Outcome measure will be assessed and data will be presented in june 2018
measure: Vomiting
timeFrame: Outcome measure will be assessed and data will be presented in june 2018
measure: Dizziness
timeFrame: Outcome measure will be assessed and data will be presented in june 2018
measure: Sedation
timeFrame: Outcome measure will be assessed and data will be presented in june 2018
measure: LOS
timeFrame: Outcome measure will be assessed and data will be presented in june 2018
measure: Readmission
timeFrame: Outcome measure will be assessed and data will be presented in june 2018
measure: Mortality
timeFrame: Outcome measure will be assessed and data will be presented in june 2018
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: Zealand University Hospital
state: Zealand
Study officials:
affiliation: Zealand University Hospital, Koege
name: Ole Mathiesen, MD.PhD
role: STUDY_DIRECTOR
References:
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citation: Moore A, Derry S, Eccleston C, Kalso E. Expect analgesic failure; pursue analgesic success. BMJ. 2013 May 3;346:f2690. doi: 10.1136/bmj.f2690. No abstract available.
citation: Moore RA, Straube S, Aldington D. Pain measures and cut-offs - 'no worse than mild pain' as a simple, universal outcome. Anaesthesia. 2013 Apr;68(4):400-12. doi: 10.1111/anae.12148. Epub 2013 Jan 24. No abstract available.
citation: Geisler A, Dahl JB, Karlsen AP, Persson E, Mathiesen O. Low degree of satisfactory individual pain relief in post-operative pain trials. Acta Anaesthesiol Scand. 2017 Jan;61(1):83-90. doi: 10.1111/aas.12815. Epub 2016 Oct 3.
citation: Srikandarajah S, Gilron I. Systematic review of movement-evoked pain versus pain at rest in postsurgical clinical trials and meta-analyses: a fundamental distinction requiring standardized measurement. Pain. 2011 Aug;152(8):1734-1739. doi: 10.1016/j.pain.2011.02.008. Epub 2011 Mar 12.
citation: Geisler A, Zachodnik J, Nersesjan M, Persson E, Mathiesen O. Postoperative Pain Management and Patient Evaluations After Five Different Surgical Procedures. A Prospective Cohort Study. Pain Manag Nurs. 2022 Dec;23(6):791-799. doi: 10.1016/j.pmn.2022.06.006. Epub 2022 Aug 6.