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NCT00653367 Clinical Trial

Evaluation of Chronic Pain After Nerve Section During Thoracotomy

Lung Cancer Clinical Trial

Official title:
Post Thoracotomy Pain After Nerve Section

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00653367
Other study ID # RH-EKPF-2008-01
Secondary ID
Status Withdrawn
Phase N/A
First received April 1, 2008
Last updated February 23, 2012
Start date December 2011
Est. completion date December 2012

Study information
Verified date August 2011
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority Denmark: National Board of HealthDenmark: De Videnskabsetiske Komiteer for Region Hovedstaden
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate if controlled nerve section reduces chronic pain after thoracotomy.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2012
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Patients included for anterior or lateral thoracotomy

Exclusion Criteria:

- Unable to give consent due to age, cognitive reduction or otherwise

- Neurological disease or symptoms affection thoracic area

- Chronic pain prior to surgery

- Inability to supply the patient with an epidural catheter

- Pneumonectomy

- Prolonged infection at surgical site

- Invasive tumor growth

- Need for repeated surgery at site

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Procedure:
• Nerve section
Intercostal nerve is divided during surgery

Locations
Country Name City State
Denmark Section for Surgical Pathophysiology 4074 Copenhagen

Sponsors (1)
Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain (NRS) 3 months postoperatively No
Secondary QST parameters (sensory thresholds to cool/Warmth) 3 months postoperatively No
Secondary Social well-being (HADS / PCS) 3 months postoperatively No
Secondary Function (pain impairment of Activities of Daily Life) 3 months postoperatively No
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