Post-Thoracotomy Closure Study

Post Thoracotomy Pain Syndrome Clinical Trial

Official title:

Post-Thoracotomy Pain Syndrome: A Randomized, Double Blind, Study Comparing Closure Techniques

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01898468
• Other study ID #: UHN13-5894
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: December 2019

Study information

• Verified date: October 2018
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Post-thoracotomy Pain Syndrome (PTPS) is defined as "pain that recurs or persists along a thoracotomy scar at least 2 months following surgery." PTPS presents a frustrating challenge to patients and healthcare providers alike. PTPS can affect up to 80% of patients undergoing thoracotomies, and results in significant impairment. A proposed mechanism for PTPS is the compression of the intercostal nerves during routine closure. Closure of thoracotomies using intracostal sutures is a novel technique where sutures are passed through holes drilled into the rib; thus, avoiding compression of the nerves. We propose a double-blind, randomized control study involving 90 patients undergoing elective posterolateral thoracotomies. Participants will be randomly assigned to undergo thoracotomy closure with pericostal sutures or intracostal sutures. Our primary outcome will assess the incidence and severity of PTPS at 3, 6, and 12 months after surgery between groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients 18-88 years age
• Patients undergoing surgery with an open thoracotomy incision

Exclusion Criteria:

• Patient refusal
• Inability to give informed consent
• Concurrent drug addiction or methadone use
• Present chronic pain syndrome
• Significant psychiatric illness excluding depression
• Cannot understand English, read or write in English independently

Related Conditions & MeSH terms

• Post Thoracotomy Pain Syndrome
• Syndrome

Intervention

Procedure:
• Pericostal Closure Technique

• Intracostal Closure Technique

Locations

Country	Name	City	State
Canada	Toronto General Hospital	Toronto	Ontario
Canada	Toronto General Hospital, University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of post-thoracotomy pain	A Numerical Rating Score (NRS) for maximal daily pain from the patients surgical incision will also be measured (0 = no pain, 10 = worst possible pain) 3 months after surgery.	3 months post surgery