Chronic Postoperative PainNCT02630849
Does a Multimodal no-Compression Suture Technique of the Intercostal Space Reduce Chronic Post-Thoracotomy Pain?
A study testing intercostal muscle flap and pericostal no-compression suture and Standard suture technique of the intercostal space in people with Chronic Postoperative Pain, run by University of Roma La Sapienza.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Chronic Postoperative Pain
- What is being tested?
- intercostal muscle flap and pericostal no-compression suture and Standard suture technique of the intercostal space
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients who were scheduled to undergo a muscle-sparing lateral mini-thoracotomy for different thoracic diseases were eligible for this trial.
Who cannot join
- 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.
About this study
Official title: Does a Multimodal no-Compression Suture Technique of the Intercostal Space Reduce Chronic Post-Thoracotomy Pain? A Prospective Randomized Study
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.
Read the 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.
- Conditions
- Chronic Postoperative Pain
- Being tested
- intercostal muscle flap and pericostal no-compression suture, Standard suture technique of the intercostal space
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intercostal muscle flap and pericostal no-compression sutureProcedure or surgery
intercostal muscle flap and pericostal no-compression suture of the intercostal space
Standard suture technique of the intercostal spaceProcedure or surgery
Standard suture technique of the intercostal space associated with an intrapleural intercostal nerve block
| Study group | Role | What they receive |
|---|---|---|
| IMF group | Experimental | intercostal muscle flap and pericostal no-compression suture of the intercostal space Receives: Procedure: intercostal muscle flap and pericostal no-compression suture |
| IINB group | Active comparator | Standard suture technique of the intercostal space associated with an intrapleural intercostal nerve block Receives: Procedure: Standard suture technique of the intercostal space |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months after surgery
Secondary outcomes (2)
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).
Measured: 1 month after surgery
Pulmonary functional tests
spirometry and 6-minute walking test [6-MWT] were evaluated in both groups to assess the differences in lung function
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2015 (estimated)
- Study startOct 2011
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohsen Ibrahim, University of Roma La Sapienza
- Investigators
- Erino A. Rendina, Professor, Study chair, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02630849
- Sponsor's protocol ID
- 1222/13
- Status last verified
- Dec 2015
- First submitted
- 7 Dec 2015
- Last updated
- 15 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 8826494Cerfolio 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.
PubMed 18498792D'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.
PubMed 16481188
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Multimodal no-Compression Suture Technique of the Intercostal Space Reduce Chronic Post-Thoracotomy Pain? A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT02630849
- Acronym / sponsor ID
- 1222/13
- Conditions
- Chronic Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 15 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMF group | Experimental | Procedure: intercostal muscle flap and pericostal no-compression sutureintercostal muscle flap and pericostal no-compression suture of the intercostal space |
| IINB group | Active comparator | Procedure: Standard suture technique of the intercostal spaceStandard suture technique of the intercostal space associated with an intrapleural intercostal nerve block |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients who were scheduled to undergo a muscle-sparing lateral mini-thoracotomy for different thoracic diseases were eligible for this trial.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intercostal muscle flap and pericostal no-compression sutureintercostal muscle flap and pericostal no-compression suture of the intercostal space | Procedure or surgery | IMF group |
| Standard suture technique of the intercostal spaceStandard suture technique of the intercostal space associated with an intrapleural intercostal nerve block | Procedure or surgery | IINB group |
Primary outcome
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).
2 secondary outcomes
Mid term Brief Pain Inventory Scale Variation
Time frame: 1 month after surgery
Pulmonary functional tests
Time frame: 6 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2015.
- Background: PubMed 8826494Caraceni 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.
- Background: PubMed 18498792Cerfolio 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.
- Background: PubMed 16481188D'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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erino A. Rendina, Professor study chair
University of Roma La Sapienza
Questions about this trial
What is this clinical trial studying?
A study testing intercostal muscle flap and pericostal no-compression suture and Standard suture technique of the intercostal space in people with Chronic Postoperative Pain, run by University of Roma La Sapienza.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long term Brief Pain Inventory Scale Variation (time frame: 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02630849, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2015.