Post-Thoracotomy Closure Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Post Thoracotomy Pain Syndrome

Intervention / Treatment
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* Procedure: Pericostal Closure Technique
* Procedure: Intracostal Closure Technique


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intracostal Closure Technique<br>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. | Procedure: Intracostal Closure Technique<br> <br> |
| Active Comparator: Pericostal Closure Technique<br>Closure involves placing sutures around the ribs in the standard pericostal fashion | Procedure: Pericostal Closure Technique<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuropathic pain symptoms, Intracostal Closure Technique, Pericostal Suture Closure Technique, Post surgical pain, Post thoracotomy pain