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

Pain, Postoperative Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03080272
• Other study ID #: SM3-AG-2017
• Status: Completed
• Start date: March 3, 2017
• Est. completion date: January 8, 2019

Study information

• Verified date: January 2019
• Source: Zealand University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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 information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: January 8, 2019
• Est. primary completion date: January 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Other:
• no intervention will take place
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

Locations

Country	Name	City	State
Denmark	Zealand University Hospital	Køge	Zealand

Sponsors (1)

Lead Sponsor	Collaborator
Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (10)

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. Review. — View 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. — View Citation

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;(3):CD008261. doi: 10.1002/14651858.CD008261.pub2. Review. — View Citation

Højer 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. Review. — View Citation

Kehlet H, Dahl JB. Anaesthesia, surgery, and challenges in postoperative recovery. Lancet. 2003 Dec 6;362(9399):1921-8. Review. — View Citation

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. Review. — View 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. — View 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. Review. — View Citation

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. — View 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):1734-9. doi: 10.1016/j.pain.2011.02.008. Epub 2011 Mar 12. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain during mobilisation late	Proportions achieving "no worse than mild pain" (Numeric Rating Scale = 3) for pain during mobilisation at 24 hours (±2h) postoperatively	Outcome measure will be assessed and data will be presented in june 2018
Secondary	Pain during mobilisation early	Proportions achieving "no worse than mild pain" (Numeric Rating Scale = 3) during mobilisation at 6 hours (±2h) postoperatively	Outcome measure will be assessed and data will be presented in june 2018
Secondary	Pain at rest early	Proportions achieving "no worse than mild pain" (Numeric Rating Scale = 3) at rest at 6h (±2h) and 24h (±2h) postoperatively	Outcome measure will be assessed and data will be presented in june 2018
Secondary	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	Outcome measure will be assessed and data will be presented in june 2018
Secondary	Patient satisfaction	Patients` experience of pain treatment and their contentment hereof using a questionnaire based on "PAIN OUT" at 24h (±2h) postoperatively	Outcome measure will be assessed and data will be presented in june 2018
Secondary	Morphine consumption	Morphine i.v. equivalent consumption (mg) the first 24h postoperatively (including opioids given as pre-medication	Outcome measure will be assessed and data will be presented in june 2018
Secondary	Non opioid use	Non-opioid analgesic usage the first 24h postoperatively (including non-opioids given as pre-medication)	Outcome measure will be assessed and data will be presented in june 2018
Secondary	Nausea	Nausea measured by Verbal Rating Scale at T6 og T24 hours postoperatively	Outcome measure will be assessed and data will be presented in june 2018
Secondary	Vomiting	Vomiting (number of episodes 0-24 hours) postoperatively	Outcome measure will be assessed and data will be presented in june 2018
Secondary	Dizziness	Dizziness measured by Verbal Rating Scale at T6 and T24 hours	Outcome measure will be assessed and data will be presented in june 2018
Secondary	Sedation	Sedation measured by Verbal Rating Scale at T6 og T24 hours postoperatively	Outcome measure will be assessed and data will be presented in june 2018
Secondary	LOS	Length of postoperative hospital stay measured in days	Outcome measure will be assessed and data will be presented in june 2018
Secondary	Readmission	Re-admission within 90 days postoperatively	Outcome measure will be assessed and data will be presented in june 2018
Secondary	Mortality	Mortality within the first 90 days	Outcome measure will be assessed and data will be presented in june 2018