Does a Multimodal no-Compression Suture Technique of the Intercostal Space Reduce Chronic Post-Thoracotomy Pain?

Study Overview
=================
Brief Summary
-----------------
Chronic post-thoracotomy pain is a significant adverse outcome of thoracic surgery. transcollation technology evaluated with a prospective randomized trial the effect of a multimodal no-compression suture technique of the intercostal space on postoperative pain occurrence in patients undergoing mini-thoracotomy. Patients undergoing a muscle-sparing lateral mini-thoracotomy for different thoracic diseases were randomly divided into two groups:one group received intercostal muscle flap harvesting and pericostal no-compression edge suture (IMF group), and the second group received a standard suture technique associated with an intrapleural intercostal nerve block (IINB group). The aim of the study was to demonstrate that the multimodal no-compression suture technique is a rapid and feasible procedure reducing early and chronic post-thoracotomy pain intensity.

Detailed Description
-----------------
Patients' data were prospectively recorded in a single database and surgery was performed in a single thoracic center in order to achieve homogenous treatment. After acceptance from the Ethics Committee of our Institution, a prospective randomized study of 487 patients was performed from October 2011 to October 2013 in the Thoracic Surgery Division - Sant'Andrea Hospital, Faculty of Medicine and Psychology, University of Rome Sapienza. All patients who were scheduled to undergo a muscle-sparing lateral mini-thoracotomy for different thoracic diseases were eligible for this trial. Exclusion criteria were: history of previous thoracotomy, chronic pain syndrome (any type of pain), opioid/steroid use 6 months before surgery, chest trauma with rib fractures, radiologic evidence of parietal pleural or chest wall tumor invasion, and previous neoadjuvant or radiation therapy. Preoperative consent was obtained from all patients, informed that they would have one of the two methods of chest closure. Pulmonary function tests (spirometry and 6-minute walking test [6-MWT]) were performed in all patients preoperatively and at 1 and 6 months postoperatively. All patients received our standard muscle-sparing lateral minithoracotomy through the fifth intercostal space without division of the latissimus dorsi muscle and the serratus anterior muscle. The postoperative analgesic protocol was the same for all patients in both groups, and consisted of a continuous intravenous infusion of tramadol (10 mg/h) and ketorolac tromethamine (3 mg/h), starting at the time of surgical skin incision and continuing until 48-72 h after surgery. Intravenous analgesia was then continued with ketorolac tromethamine (10 mg tid) and paracetamol (1 g tid) until discharge from the hospital.

Official Title
-----------------
Does a Multimodal no-Compression Suture Technique of the Intercostal Space Reduce Chronic Post-Thoracotomy Pain? A Prospective Randomized Study

Conditions
-----------------
Chronic Postoperative Pain

Intervention / Treatment
-----------------
* Procedure: intercostal muscle flap and pericostal no-compression suture
* Procedure: Standard suture technique of the intercostal space


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who were scheduled to undergo a muscle-sparing lateral mini-thoracotomy for different thoracic diseases were eligible for this trial. Exclusion Criteria: History of previous thoracotomy Chronic pain syndrome (any type of pain) Opioid/steroid use 6 months before surgery Chest trauma with rib fractures Radiologic evidence of parietal pleural or chest wall tumor invasion Previous neoadjuvant or radiation therapy.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMF group<br>intercostal muscle flap and pericostal no-compression suture of the intercostal space | Procedure: intercostal muscle flap and pericostal no-compression suture<br>* intercostal muscle flap and pericostal no-compression suture of the intercostal space<br>|
| Active Comparator: IINB group<br>Standard suture technique of the intercostal space associated with an intrapleural intercostal nerve block | Procedure: Standard suture technique of the intercostal space<br>* Standard suture technique of the intercostal space associated with an intrapleural intercostal nerve block<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long term Brief Pain Inventory Scale Variation | the aim of the study is to evaluate the variation of the brief pain inventory scale (BPI) in patients treated with a non-divided intercostal muscle flap associated with pericostal edge sutures (thus protecting the intercostal nerves from trauma) on long-term versus patients who will receive our standard pain control strategy (intrapleural intercostal nerve block). | 6 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mid term Brief Pain Inventory Scale Variation | the aim of the study is to evaluate the variation of the brief pain inventory scale (BPI) in patients treated with a non-divided intercostal muscle flap associated with pericostal edge sutures (thus protecting the intercostal nerves from trauma) after 1 month versus patients who will receive our standard pain control strategy (intrapleural intercostal nerve block). | 1 month after surgery | 
| Pulmonary functional tests | spirometry and 6-minute walking test [6-MWT] were evaluated in both groups to assess the differences in lung function | 6 months after surgery |