Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03080272
Enrollment
190
Registered
2017-03-15
Start date
2017-03-03
Completion date
2019-01-08
Last updated
2019-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Keywords

individual patient

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.

Interventions

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

Sponsors

Zealand University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain during mobilisation lateOutcome measure will be assessed and data will be presented in june 2018Proportions achieving no worse than mild pain (Numeric Rating Scale ≤ 3) for pain during mobilisation at 24 hours (±2h) postoperatively

Secondary

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026