Does a Multimodal no-Compression Suture Technique of the Intercostal Space Reduce Chronic Post-Thoracotomy Pain?
Primary Purpose
Chronic Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
intercostal muscle flap and pericostal no-compression suture
Standard suture technique of the intercostal space
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Postoperative Pain
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
IMF group
IINB group
Arm Description
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
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
Pulmonary functional tests
spirometry and 6-minute walking test [6-MWT] were evaluated in both groups to assess the differences in lung function
Full Information
NCT ID
NCT02630849
First Posted
December 7, 2015
Last Updated
December 14, 2015
Sponsor
University of Roma La Sapienza
1. Study Identification
Unique Protocol Identification Number
NCT02630849
Brief Title
Does a Multimodal no-Compression Suture Technique of the Intercostal Space Reduce Chronic Post-Thoracotomy Pain?
Official Title
Does a Multimodal no-Compression Suture Technique of the Intercostal Space Reduce Chronic Post-Thoracotomy Pain? A Prospective Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
380 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IMF group
Arm Type
Experimental
Arm Description
intercostal muscle flap and pericostal no-compression suture of the intercostal space
Arm Title
IINB group
Arm Type
Active Comparator
Arm Description
Standard suture technique of the intercostal space associated with an intrapleural intercostal nerve block
Intervention Type
Procedure
Intervention Name(s)
intercostal muscle flap and pericostal no-compression suture
Intervention Description
intercostal muscle flap and pericostal no-compression suture of the intercostal space
Intervention Type
Procedure
Intervention Name(s)
Standard suture technique of the intercostal space
Intervention Description
Standard suture technique of the intercostal space associated with an intrapleural intercostal nerve block
Primary Outcome Measure Information:
Title
Long term Brief Pain Inventory Scale Variation
Description
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).
Time Frame
6 months after surgery
Secondary Outcome Measure Information:
Title
Mid term Brief Pain Inventory Scale Variation
Description
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).
Time Frame
1 month after surgery
Title
Pulmonary functional tests
Description
spirometry and 6-minute walking test [6-MWT] were evaluated in both groups to assess the differences in lung function
Time Frame
6 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erino A. Rendina, Professor
Organizational Affiliation
University of Roma La Sapienza
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
8826494
Citation
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.
Results Reference
background
PubMed Identifier
18498792
Citation
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.
Results Reference
background
PubMed Identifier
16481188
Citation
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.
Results Reference
background
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Does a Multimodal no-Compression Suture Technique of the Intercostal Space Reduce Chronic Post-Thoracotomy Pain?
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