Post-Thoracotomy Closure Study

University Health Network, Toronto

Status: Completed

Conditions: Post Thoracotomy Pain Syndrome

Treatments: Procedure: Intracostal Closure Technique; Procedure: Pericostal Closure Technique

Study type: Interventional

Funder types: Other

Identifiers

NCT01898468

UHN13-5894

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 2 patient groups

Intracostal Closure Technique

Active Comparator group

Description:

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.

Treatment:

Procedure: Intracostal Closure Technique

Pericostal Closure Technique

Active Comparator group

Description:

Closure involves placing sutures around the ribs in the standard pericostal fashion

Treatment:

Procedure: Pericostal Closure Technique