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

Chronic Postoperative Pain Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Postoperative Pain
• Pain, Postoperative

• NCT number: NCT02630849
• Study type: Interventional
• Source: University of Roma La Sapienza
• Status: Completed
• Phase: N/A
• Start date: October 2011
• Completion date: October 2013