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Pain, PostoperativeNCT03080272

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

An observational study of Pain, Postoperative, run by Zealand University Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Pain, Postoperative
How many people
190 participants
Where
1 siteDenmark
Study dates
3 Mar 2017to 8 Jan 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients undergoing a relevant surgical intervention at Zealand University Hospital, Koege and meeting the inclusion criteria

Who may be able to join

  • 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 -

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site
  • Zealand University Hospital

    Køge, Region Sjælland, 4600

Other trials in Denmark

About this study

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

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.

Read the 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.

Being tested
no intervention will take place
Keywords
individual patient
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • no intervention will take placeOther

    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

Study groups in NCT03080272
Study groupRoleWhat they receive
Spinal SurgeryNo intervention will take place. Recruiting Autumn 2017 until spring 2018
Receives: Other: no intervention will take place
Gastric sleeveNo intervention will take place. Recruiting Autumn 2017 until spring 2018
Receives: Other: no intervention will take place
Total knee arthroplastyNo intervention will take place. Recruiting Spring 2018 until Summer 2018
Receives: Other: no intervention will take place
Shoulder arthroplastyNo intervention will take place. Recruiting Winter 2017 until Summer 2018
Receives: Other: no intervention will take place
Maxillofacial surgeryNo intervention will take place. Recruiting 6 march 2017 until Autumn 2017
Receives: Other: no intervention will take place

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain during mobilisation late

    Proportions achieving "no worse than mild pain" (Numeric Rating Scale ≤ 3) for pain during mobilisation at 24 hours (±2h) postoperatively

    Measured: Outcome measure will be assessed and data will be presented in june 2018

Secondary outcomes (13)
  1. Pain during mobilisation early

    Proportions achieving "no worse than mild pain" (Numeric Rating Scale ≤ 3) during mobilisation at 6 hours (±2h) postoperatively

    Measured: Outcome measure will be assessed and data will be presented in june 2018

  2. Pain at rest early

    Proportions achieving "no worse than mild pain" (Numeric Rating Scale ≤ 3) at rest at 6h (±2h) and 24h (±2h) postoperatively

    Measured: Outcome measure will be assessed and data will be presented in june 2018

  3. 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

    Measured: Outcome measure will be assessed and data will be presented in june 2018

  4. Patient satisfaction

    Patients' experience of pain treatment and their contentment hereof using a questionnaire based on "PAIN OUT" at 24h (±2h) postoperatively

    Measured: Outcome measure will be assessed and data will be presented in june 2018

  5. Morphine consumption

    Morphine i.v. equivalent consumption (mg) the first 24h postoperatively (including opioids given as pre-medication

    Measured: Outcome measure will be assessed and data will be presented in june 2018

  6. Non opioid use

    Non-opioid analgesic usage the first 24h postoperatively (including non-opioids given as pre-medication)

    Measured: Outcome measure will be assessed and data will be presented in june 2018

  7. Nausea

    Nausea measured by Verbal Rating Scale at T6 og T24 hours postoperatively

    Measured: Outcome measure will be assessed and data will be presented in june 2018

  8. Vomiting

    Vomiting (number of episodes 0-24 hours) postoperatively

    Measured: Outcome measure will be assessed and data will be presented in june 2018

  9. Dizziness

    Dizziness measured by Verbal Rating Scale at T6 and T24 hours

    Measured: Outcome measure will be assessed and data will be presented in june 2018

  10. Sedation

    Sedation measured by Verbal Rating Scale at T6 og T24 hours postoperatively

    Measured: Outcome measure will be assessed and data will be presented in june 2018

  11. LOS

    Length of postoperative hospital stay measured in days

    Measured: Outcome measure will be assessed and data will be presented in june 2018

  12. Readmission

    Re-admission within 90 days postoperatively

    Measured: Outcome measure will be assessed and data will be presented in june 2018

  13. Mortality

    Mortality within the first 90 days

    Measured: Outcome measure will be assessed and data will be presented in june 2018

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2017
  2. Study start3 Mar 2017
  3. Primary completion8 Jan 2019
  4. Study completion8 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
190 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03080272
Sponsor's protocol ID
SM3-AG-2017
Status last verified
Jan 2019
First submitted
27 Feb 2017
Last updated
9 Jan 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided: no plan

Publications

  • Kehlet H. Fast-track surgery-an update on physiological care principles to enhance recovery. Langenbecks Arch Surg. 2011 Jun;396(5):585-90. doi: 10.1007/s00423-011-0790-y. Epub 2011 Apr 6.

    PubMed 21468643
  • Kehlet H, Dahl JB. Anaesthesia, surgery, and challenges in postoperative recovery. Lancet. 2003 Dec 6;362(9399):1921-8. doi: 10.1016/S0140-6736(03)14966-5.

    PubMed 14667752
  • Dahl JB, Mathiesen O, Kehlet H. An expert opinion on postoperative pain management, with special reference to new developments. Expert Opin Pharmacother. 2010 Oct;11(15):2459-70. doi: 10.1517/14656566.2010.499124.

    PubMed 20586709
  • Rathmell JP, Wu CL, Sinatra RS, Ballantyne JC, Ginsberg B, Gordon DB, Liu SS, Perkins FM, Reuben SS, Rosenquist RW, Viscusi ER. Acute post-surgical pain management: a critical appraisal of current practice, December 2-4, 2005. Reg Anesth Pain Med. 2006 Jul-Aug;31(4 Suppl 1):1-42. doi: 10.1016/j.rapm.2006.05.002.

    PubMed 16849098
  • Gurusamy KS, Vaughan J, Toon CD, Davidson BR. Pharmacological interventions for prevention or treatment of postoperative pain in people undergoing laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2014 Mar 28;2014(3):CD008261. doi: 10.1002/14651858.CD008261.pub2.

    PubMed 24683057
  • Hojer Karlsen AP, Geisler A, Petersen PL, Mathiesen O, Dahl JB. Postoperative pain treatment after total hip arthroplasty: a systematic review. Pain. 2015 Jan;156(1):8-30. doi: 10.1016/j.pain.0000000000000003.

    PubMed 25599296
  • 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.

    PubMed 23645858
  • 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.

    PubMed 23347230
  • 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.

    PubMed 27696343
  • 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.

    PubMed 21402445
  • 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.

    PubMed 35941015

Questions about this trial

What is this clinical trial studying?

An observational study of Pain, Postoperative, run by Zealand University Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain during mobilisation late (time frame: Outcome measure will be assessed and data will be presented in june 2018). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03080272, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2019.

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