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

Pain Clinical Trial

— FACTS2  

Official title:

From Acute to Chronic Postoperative Shoulder Pain in Patients for Elective Lobectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01552746
• Other study ID #: FACTS2
• Status: Completed
• Phase: N/A
• First received: March 2, 2012
• Last updated: June 16, 2014
• Start date: January 2012
• Est. completion date: December 2012

Study information

• Verified date: June 2014
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pain
• Shoulder Pain

Locations

Country	Name	City	State
Denmark	Departement V of anesthesia and intensive care, Odense University Hospital	Odense

Sponsors (2)

Lead Sponsor	Collaborator
Odense University Hospital	Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder Pain		12 months	No
Primary	Shoulder range of motion	Shoulder range of motion in: flexion, outward rotation, inward rotation, adduction	12 months	No
Secondary	Thoracical Pain		12 months	No
Secondary	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	No
Secondary	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	No
Secondary	Hospital Anxiety and Depression Score		12 months	No