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NCT Number: NCT02630849

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

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.

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Key information

Conditions

Chronic Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

25 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

intercostal muscle flap and pericostal no-compression suture

Procedure

intercostal muscle flap and pericostal no-compression suture of the intercostal space

Standard suture technique of the intercostal space

Procedure

Standard suture technique of the intercostal space associated with an intrapleural intercostal nerve block

Primary outcomes

  1. Long term Brief Pain Inventory Scale Variation

    Time frame: 6 months after surgery

    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).

Secondary outcomes

  1. Mid term Brief Pain Inventory Scale Variation

    Time frame: 1 month after surgery

    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).

  2. Pulmonary functional tests

    Time frame: 6 months after surgery

    spirometry and 6-minute walking test [6-MWT] were evaluated in both groups to assess the differences in lung function

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 15, 2015
Registry last updated
Dec 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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