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

NCT01552746 | Completed

• 1 other identifier: FACTS2
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain

Keywords

Postoperative shoulder pain; Persisting postoperative pain

Outcome Measures

Primary Outcomes (2)

• Shoulder Pain

  12 months

• Shoulder range of motion

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

  12 months

Secondary Outcomes (4)

• Thoracical Pain

  12 months

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

  1. postoperative day

• Quantitative sensory testing values on the shoulder

  12 months

• Hospital Anxiety and Depression Score

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Odense University Hospital: lead
• Vejle Hospital: collaborator

Study Sites (1)

Departement V of anesthesia and intensive care, Odense University Hospital

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Morten R Eckhardt, MD

  Departement V of anesthesia and intensive care, Odense University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Afdelingslæge, Ph.d.-studerende

Study Record Dates

• First Submitted: March 2, 2012
• First Posted: March 13, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 17, 2014

Record last verified: 2014-06

Locations

DK (1)