From ACute To Chronic Postoperative Shoulder Pain in Patients for Elective Lobectomy (FACTS2)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Odense University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Vejle Hospital
Information provided by (Responsible Party):
Morten Rune Eckhardt, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01552746
First received: March 2, 2012
Last updated: March 9, 2012
Last verified: March 2012
  Purpose

Shoulder pain is a well known problem after thoracical surgery. The pathogenesis of the pain is uncertain, but mainly a mix of referred pain and mechanical strain to the shoulder. It is believed to last a few days. Persisting shoulder pain after thoracical surgery is a problem 1 year after surgery, but it is unknown if it is related to acute postoperative shoulder pain.

The purpose of the study is to systematically describe postoperative shoulder pain after lobectomy and examine the time progress up to 1 year after surgery.


Condition
Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: From Acute to Chronic Postoperative Shoulder Pain in Patients for Elective Lobectomy

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Shoulder Pain [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Shoulder range of motion [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Shoulder range of motion in: flexion, outward rotation, inward rotation, adduction


Secondary Outcome Measures:
  • Thoracical Pain [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Presence of allodynia and hyperalgesia on the shoulder on the operated side. [ Time Frame: 1. postoperative day ] [ Designated as safety issue: No ]
    Presence of allodynia and hyperalgesia on the shoulder on the operated side, compared to the kontralateral shoulder.

  • Quantitative sensory testing values on the shoulder [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    Quantitative sensory testing values in referred pain area compared to kontralateral side and preoperative values.

    The following quantitative sensory tests are performed:

    Cold Detection Threshold,Warm Detection Threshold, Cold Pain Threshold, Heat Pain Threshhold, Mechanical detection Threshhold, Mechanical Pain Threshold, Mechanical Pain Sensitivity, Allodynia, Wind-Up Ratio, Vibration Detection Threshold, Pressure Pain Threshold


  • HADS-score [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Detailed Description:

Further study details are provided by Departement V, Odense University Hospital

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Consecutive patients, scheduled for elective lobectomy of the lung at Odense University Hospital

Criteria

Inclusion Criteria:

  • Patients for elective lobectomy
  • 18 years or older at the day of the operation
  • Satisfactory abilities to speak and read danish

Exclusion Criteria:

  • Previous Thoracical Surgery.
  • Patients with diseases in the nervous system.
  • Patients with preoperative shoulder pain, neuropathies or sensory disturbances in the arm or shoulder.
  • Patients who are reoperated in the thorax in the study period or any other body-region within the first 4 postoperative days.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01552746

Contacts
Contact: Morten R Eckhardt, MD +45 654 125 28 morten.rune.eckhardt@ouh.regionsyddanmark.dk
Contact: Palle Toft, MD PHD DrMed +45 654 139 47 palle.toft@ouh.regionsyddanmark.dk

Locations
Denmark
Departement V of anesthesia and intensive care, Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Morten R Eckhardt, MD    +45 654 12528    morten.rune.eckhardt@ouh.regionsyddanmark.dk   
Contact: Palle Toft, MD PHD DrMed    +45 654 139 47    palle.toft@ouh.regionsyddanmark.dk   
Principal Investigator: Morten R Eckhardt, MD         
Sponsors and Collaborators
Odense University Hospital
Vejle Hospital
Investigators
Principal Investigator: Morten R Eckhardt, MD Departement V of anesthesia and intensive care, Odense University Hospital
  More Information

No publications provided

Responsible Party: Morten Rune Eckhardt, Afdelingslæge, Ph.d.-studerende, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01552746     History of Changes
Other Study ID Numbers: FACTS2
Study First Received: March 2, 2012
Last Updated: March 9, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Odense University Hospital:
Postoperative shoulder pain
Persisting postoperative pain

Additional relevant MeSH terms:
Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014