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OpenTrials
Completed

NCT Number: NCT01552746

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

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Departement V of anesthesia and intensive care, Odense University Hospital

Odense, 5000, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Shoulder Pain

    Time frame: 12 months

  2. Shoulder range of motion

    Time frame: 12 months

    Shoulder range of motion in: flexion, outward rotation, inward rotation, adduction

Secondary outcomes

  1. Thoracical Pain

    Time frame: 12 months

  2. Presence of allodynia and hyperalgesia on the shoulder on the operated side.

    Time frame: 1. postoperative day

    Presence of allodynia and hyperalgesia on the shoulder on the operated side, compared to the contralateral shoulder.

  3. Quantitative sensory testing values on the shoulder

    Time frame: 12 months

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

    The following quantitative sensory tests are performed:

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

  4. Hospital Anxiety and Depression Score

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

  • Vejle Hospital

Registry information

Acronym: FACTS2

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 13, 2012
Registry last updated
Jun 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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