Thoracotomy Closure Technique and Postoperative Pain Study: A Randomized Controlled Trial

Study Overview
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Brief Summary
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The purpose of this study is to examine pain associated with thoracotomy (incision made during surgery to obtain access to your thoracic cavity) and how the closure technique may influence postoperative pain. Two types of routinely selected thoracotomy closure techniques will be examined; pericostal and intracostal sutures. The investigators hypothesize that intracostal sutures will result in less postoperative and chronic pain as a result of less compression of the intercostal nerve.

Official Title
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Thoracotomy Closure Technique and Postoperative Pain Study: A Randomized Controlled Trial

Conditions
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Hernia, Lung Cancer

Intervention / Treatment
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* Procedure: Pericostal suture technique
* Procedure: Intracostal suture technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing an elective procedure that will include a thoracotomy. All patients will undergo epidural catheter placement. Exclusion Criteria: Previous thoracotomy on the operative side. Previous history of chronic chest pain. Previous history of thoracic trauma on the operative side. Less than 18 years of age Inability to provide informed consent or to complete testing or data collection Need for a chest wall resection Patients requiring other incisions in addition to a thoracotomy (i.e., Laparotomy, sternotomy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pericostal Suture Technique<br>A #2 Vicryl suture is placed along the superior aspect of the rib above the specific thoracic interspace. This suture is then passed below the inferior rib along the superior aspect of the next rib below. These sutures are then tied to approximate the ribs leaving enough room for the tip of a finger. | Procedure: Pericostal suture technique<br> <br> |
| Active Comparator: Intracostal Suture Technique<br>A handheld drill is used to drill holes in the rib below the specific thoracic interspace. A #2 Vicryl suture is passed through each of the holes and then passed along the superior aspect of the rib above the specific thoracic interspace. These sutures are then tied to approximate the ribs leaving enough room for the tip of a finger. | Procedure: Intracostal suture technique<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of postoperative pain in the perioperative period. |  | 2 weeks following surgery | 
| Intensity and incidence of chronic post-thoracotomy pain |  | 6 months follwong surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rates between subjects undergoing pericostal versus intracostal thoracotomy closure technique |  | 6 months following surgery | 
| Length of hospital stay and associated hospital costs between subjects undergoing pericostal versus intracostal thoracotomy closure technique |  | 6 months following surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thoracotomy, Pain, Intracostal Suture, Pericostal Suture