NCT03080272

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

March 3, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 15, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2019

Completed
Last Updated

January 9, 2019

Status Verified

January 1, 2019

Enrollment Period

1.9 years

First QC Date

February 27, 2017

Last Update Submit

January 8, 2019

Conditions

Pain, Postoperative

Keywords

individual patient

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (13)

  • Pain during mobilisation early

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

  • Pain at rest early

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

  • Numeric Rating Scale pain levels

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

  • Patient satisfaction

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

  • Morphine consumption

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

  • +8 more secondary outcomes

Study Arms (5)

Spinal Surgery

No intervention will take place. Recruiting Autumn 2017 until spring 2018

Other: no intervention will take place

Gastric sleeve

No intervention will take place. Recruiting Autumn 2017 until spring 2018

Other: 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

Shoulder arthroplasty

No intervention will take place. Recruiting Winter 2017 until Summer 2018

Other: 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

Interventions

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

Gastric sleeveMaxillofacial surgeryShoulder arthroplastySpinal SurgeryTotal knee arthroplasty

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Age \> 18 år
  • Patients scheduled for relevant surgical procedure
  • Patients who understand and speak Danish or English -

You may not qualify if:

  • Patients who cannot cooperate
  • Alcohol and drug dependency as judged by the investigator
  • Chronic opioid dependent patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zealand University Hospital

Køge, Region Sjælland, 4600, Denmark

Location

Related Publications (11)

  • 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.

    PMID: 21468643BACKGROUND

  • 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.

    PMID: 14667752BACKGROUND

  • 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.

    PMID: 20586709BACKGROUND

  • 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.

    PMID: 16849098BACKGROUND

  • 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.

    PMID: 24683057BACKGROUND

  • 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.

    PMID: 25599296BACKGROUND

  • 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.

    PMID: 23645858BACKGROUND

  • 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.

    PMID: 23347230BACKGROUND

  • 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.

    PMID: 27696343BACKGROUND

  • 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.

    PMID: 21402445BACKGROUND

  • 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.

    PMID: 35941015DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Ole Mathiesen, MD.PhD

    Zealand University Hospital, Koege

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical nurse specialist / PhD student

Study Record Dates

First Submitted

February 27, 2017

First Posted

March 15, 2017

Study Start

March 3, 2017

Primary Completion

January 8, 2019

Study Completion

January 8, 2019

Last Updated

January 9, 2019

Record last verified: 2019-01

Locations

DK(1)