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

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.

Study Overview

• Status: Completed
• Conditions: Pain

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Denmark
  • Odense, Denmark, 5000
    • Departement V of anesthesia and intensive care, Odense University Hospital

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder Pain		12 months
Shoulder range of motion	Shoulder range of motion in: flexion, outward rotation, inward rotation, adduction	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thoracical Pain		12 months
Presence of allodynia and hyperalgesia on the shoulder on the operated side.	Presence of allodynia and hyperalgesia on the shoulder on the operated side, compared to the contralateral shoulder.	1. postoperative day
Quantitative sensory testing values on the shoulder	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	12 months
Hospital Anxiety and Depression Score		12 months

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Collaborators: Vejle Hospital
• Investigators: Principal Investigator: Morten R Eckhardt, MD, Departement V of anesthesia and intensive care, Odense University Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: March 2, 2012
• First Submitted That Met QC Criteria: March 9, 2012
• First Posted (Estimate): March 13, 2012

Study Record Updates

• Last Update Posted (Estimate): June 17, 2014
• Last Update Submitted That Met QC Criteria: June 16, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Postoperative shoulder pain; Persisting postoperative pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain
• Other Study ID Numbers: FACTS2