Does a Multimodal no-Compression Suture Technique of the Intercostal Space Reduce Chronic Post-Thoracotomy Pain?
Condition: Chronic Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

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.
    

Intervention name(s): intercostal muscle flap and pericostal no-compression suture; Standard suture technique of the intercostal space
Intervention type(s): Procedure; Procedure
Intervention description(s): intercostal muscle flap and pericostal no-compression suture of the intercostal space; Standard suture technique of the intercostal space associated with an intrapleural intercostal nerve block
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment