Does a Multimodal no-Compression Suture Technique of the Intercostal Space Reduce Chronic Post-Thoracotomy Pain?
NCT ID: NCT02630849
Last Updated: 2015-12-15
Study Results
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Basic Information
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COMPLETED
NA
380 participants
INTERVENTIONAL
2011-10-31
2013-10-31
Brief Summary
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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
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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IMF group
intercostal muscle flap and pericostal no-compression suture of the intercostal space
intercostal muscle flap and pericostal no-compression suture
intercostal muscle flap and pericostal no-compression suture of the intercostal space
IINB group
Standard suture technique of the intercostal space associated with an intrapleural intercostal nerve block
Standard suture technique of the intercostal space
Standard suture technique of the intercostal space associated with an intrapleural intercostal nerve block
Interventions
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intercostal muscle flap and pericostal no-compression suture
intercostal muscle flap and pericostal no-compression suture of the intercostal space
Standard suture technique of the intercostal space
Standard suture technique of the intercostal space associated with an intrapleural intercostal nerve block
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
25 Years
80 Years
ALL
No
Sponsors
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University of Roma La Sapienza
OTHER
Responsible Party
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Mohsen Ibrahim
Associate Professor
Principal Investigators
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Erino A. Rendina, Professor
Role: STUDY_CHAIR
University of Roma La Sapienza
References
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Caraceni A, Mendoza TR, Mencaglia E, Baratella C, Edwards K, Forjaz MJ, Martini C, Serlin RC, de Conno F, Cleeland CS. A validation study of an Italian version of the Brief Pain Inventory (Breve Questionario per la Valutazione del Dolore). Pain. 1996 Apr;65(1):87-92. doi: 10.1016/0304-3959(95)00156-5.
Cerfolio RJ, Bryant AS, Maniscalco LM. A nondivided intercostal muscle flap further reduces pain of thoracotomy: a prospective randomized trial. Ann Thorac Surg. 2008 Jun;85(6):1901-6; discussion 1906-7. doi: 10.1016/j.athoracsur.2008.01.041.
D'Andrilli A, Ibrahim M, Ciccone AM, Venuta F, De Giacomo T, Massullo D, Pinto G, Rendina EA. Intrapleural intercostal nerve block associated with mini-thoracotomy improves pain control after major lung resection. Eur J Cardiothorac Surg. 2006 May;29(5):790-4. doi: 10.1016/j.ejcts.2006.01.002. Epub 2006 Feb 14.
Other Identifiers
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1222/13
Identifier Type: -
Identifier Source: org_study_id