Post-Thoracotomy Closure Study

Not Applicable

Completed

• Conditions: Post Thoracotomy Pain Syndrome
• Interventions: Procedure: Pericostal Closure Technique; Procedure: Intracostal Closure Technique

• Registration Number: NCT01898468
• Lead Sponsor: University Health Network, Toronto

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-07-02
• Study First Submitted QC: 2013-07-09
• Study First Posted: 2013-07-12
• Status Verified: 2018-10
• Primary Completion: 2019-09
• Study Completion: 2019-12
• Last Update Submitted: 2020-12-04
• Last Update Posted: 2020-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pericostal Closure Technique	Pericostal Closure Technique	Closure involves placing sutures around the ribs in the standard pericostal fashion
Intracostal Closure Technique	Intracostal Closure Technique	Closure involves drilling four evenly spaced holes using a 5-mm bit attached to the end of a Stryker drill into the bed of the sixth rib.

Primary Outcome Measures

Name	Time	Method
Incidence and severity of post-thoracotomy pain	3 months post surgery	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.

Trial Locations

Locations (2)

Toronto General Hospital, University Health Network; 🇨🇦 Toronto, Ontario, Canada

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada