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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
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Postoperative Pain

Eligibility Criteria

25 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 7, 2015
    Last Updated
    December 14, 2015
    Sponsor
    University of Roma La Sapienza
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    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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