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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Other: no intervention will take place

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.

• Study Type: Observational
• Enrollment (Actual): 190

Contacts and Locations

Study Locations

• Denmark
  • Zealand
    • Køge, Zealand, Denmark, 4600
      • Zealand University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Spinal Surgery; No intervention will take place. Recruiting Autumn 2017 until spring 2018	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
Gastric sleeve; No intervention will take place. Recruiting Autumn 2017 until spring 2018	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
Total knee arthroplasty; No intervention will take place. Recruiting Spring 2018 until Summer 2018	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
Shoulder arthroplasty; No intervention will take place. Recruiting Winter 2017 until Summer 2018	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
Maxillofacial surgery; No intervention will take place. Recruiting 6 march 2017 until Autumn 2017	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
Vomiting	Vomiting (number of episodes 0-24 hours) postoperatively	Outcome measure will be assessed and data will be presented in june 2018
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
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
LOS	Length of postoperative hospital stay measured in days	Outcome measure will be assessed and data will be presented in june 2018
Readmission	Re-admission within 90 days postoperatively	Outcome measure will be assessed and data will be presented in june 2018
Mortality	Mortality within the first 90 days	Outcome measure will be assessed and data will be presented in june 2018

Collaborators and Investigators

• Sponsor: Zealand University Hospital
• Investigators: Study Director: Ole Mathiesen, MD.PhD, Zealand University Hospital, Koege

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2017
• Primary Completion (Actual): January 8, 2019
• Study Completion (Actual): January 8, 2019

Study Registration Dates

• First Submitted: February 27, 2017
• First Submitted That Met QC Criteria: March 8, 2017
• First Posted (Actual): March 15, 2017

Study Record Updates

• Last Update Posted (Actual): January 9, 2019
• Last Update Submitted That Met QC Criteria: January 8, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: individual patient
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: SM3-AG-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: no plan