Neuropathic PainPOPARTSNCT04300660
Post-Operative Pain After Recovery in Thoracic Surgery
An observational study of Neuropathic Pain and Post Operative Pain, run by University of Trieste at 1 site in Italy.
Trial summary
Persistent pain after surgery has significant physical and mental consequences for the patient, as well as a significant economic impact on health systems. Neuropathic pain is caused by direct or indirect damage to the somatosensitive system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain, Post Operative Pain, Thoracic Surgery
- What is being tested?
- neuropathic pain after thoracic surgery
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- 25 Oct 2017to Apr 2020
- How long will I take part?
- 30 Months
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted at our surgical center who underwent elective lobectomy, segmentectomy or atypical resection surgery with a mini-thoracotomy approach or VATS.
Who may be able to join
- Age ≥ 18 years
- Patient's consent to the trial
- Candidate to resective lung surgery (lobectomy, segmentectomy, atypical resection) with minimally invasive approach (mini-thoracotomy with muscle sparing or video-assisted thoracic surgery, VATS)
Who cannot join
- neurological and / or cognitive deficits
- inability to obtain informed consent
- surgeries that include wall resections (pleural, muscle, rib or nerve)
- pneumonectomy
- Previous thoracic surgery at the time of enrollment
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Cattinara Hospital
Trieste, 34149
Marzia Umari, MD, 347 4688773 ext. +39, marzia.umari@asuits.sanita.fvg.it
Marzia Umari, MD
About this study
Official title: POPARTS Study- Post-Operative Pain After Recovery in Thoracic Surgery: Evaluation of the Persistence of Painful Symptoms and the Incidence of Neuropathic Pain After Resective Lung Surgery
Persistent pain after surgery has significant physical and mental consequences for the patient, as well as a significant economic impact on health systems. Neuropathic pain is caused by direct or indirect damage to the somatosensitive system. In thoracic surgery, chronic neuropathic pain is represented by Post-Thoracotomic Pain Syndrome (PTPS), defined as recurrent or persistent pain in the thoracotomy scar site that persists for more than 3-6 months. Currently, in literature, the prevalence of PTPS is extremely variable. This prospective observational study aims to assess the incidence of pain in the weeks and months following surgery and to assess whether and how the presence of painful symptoms changes the patient's quality of life.
Read the detailed description
For each patient enrolled in the study, in the pre-operative phase, comorbidities, any chronic analgesic therapy and quality of life (through a dedicated questionnaire - Euro QoL 5D5L1) will be recorded. Surgical data (type of procedure, lobe affected by resection, type of approach and surgical time) and anesthesiological data (intravenous opioid, locoregional technique (s), non-opioid analgesics administered and other medications) will be collected in the perioperative phase. In the 48 hours following the surgery (in the Recovery Room, at 6h, 12h, 24h, 36h and 48h) the patient's pain data will be recorded (static, dynamic and cough-associated NRS) and those relating to any complications. The total amount of morphine administered to the patient in the first 48 hours will also be recorded. Each patient will be evaluated 7 days, 1, 3 and 6 months after the surgery by telephone interview. In this last phase, the possible presence of pain and its characteristics will be assessed, especially if these meet the criteria of neuropathic pain.
- Conditions
- Neuropathic Pain, Post Operative Pain, Thoracic Surgery
- Being tested
- neuropathic pain after thoracic surgery
- Keywords
- thoracic surgery, analgesia, chest wall analgesia, Post-Thoracotomic Pain Syndrome, VATS
- Medical subject headings
- Neuralgia, Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuropathic pain after thoracic surgeryOther
analysis of perioperative factors implicated in the onset of postoperative pain after chest surgery and the incidence of neuropathic pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of persistent post-operative pain after thoracic surgery
The incidence of static, dynamic and cough-associated pain is assessed through the numerical rate scale (NRS), by a telephone interview one week and one month after surgery. A questionnaire is submitted to the patient to analyze the characteristics of the pain and its possible impact on the patient's quality of life.
Measured: the data needed to analyze the incidence and characteristics of pain will be collected at 1 week after surgery
Incidence of persistent post-operative pain after thoracic surgery
The incidence of static, dynamic and cough-associated pain is assessed through the numerical rate scale (NRS), by a telephone interview one week and one month after surgery. A questionnaire is submitted to the patient to analyze the characteristics of the pain and its possible impact on the patient's quality of life.
Measured: the data needed to analyze the incidence and characteristics of pain will be collected at 1 month after surgery
Incidence of Chronic Pain after thoracic surgery
The possible presence and incidence of chronic pain is assessed through a telephone interview three and six months after surgery.
Measured: The data needed to analyze the presence of chronic pain will be collected at 3 months after surgery
Incidence of Chronic Pain after thoracic surgery
The possible presence and incidence of chronic pain is assessed through a telephone interview three and six months after surgery.
Measured: The data needed to analyze the presence of chronic pain will be collected at 6 months after surgery
Presence of pain with typical features of neuropathic pain in the different phases of the postoperative course
During each telephone interview the presence of neuropathic pain is assessed through a dedicated questionnaire (PainDetect Questionnaire) and the impact that this type of pain has on the patient's quality of life.
Measured: The data neede to analyze the presence of neuropathic pain will be collected at a week after the surgery
Presence of pain with typical features of neuropathic pain in the different phases of the postoperative course
During each telephone interview the presence of neuropathic pain is assessed through a dedicated questionnaire (PainDetect Questionnaire) and the impact that this type of pain has on the patient's quality of life.
Measured: The data neede to analyze the presence of neuropathic pain will be collected at a month after the surgery
Presence of pain with typical features of neuropathic pain in the different phases of the postoperative course
During each telephone interview the presence of neuropathic pain is assessed through a dedicated questionnaire (PainDetect Questionnaire) and the impact that this type of pain has on the patient's quality of life.
Measured: The data neede to analyze the presence of neuropathic pain will be collected at 3 months after the surgery
Presence of pain with typical features of neuropathic pain in the different phases of the postoperative course
During each telephone interview the presence of neuropathic pain is assessed through a dedicated questionnaire (PainDetect Questionnaire) and the impact that this type of pain has on the patient's quality of life.
Measured: The data neede to analyze the presence of neuropathic pain will be collected at 6 months after the surgery
Secondary outcomes (3)
Assessment of the incidence of chronic pain based on the different surgical techniques in thoracic surgery
the aim of this objective is to analyze whether different surgical techniques (more or less invasive) play a role in the onset of chronic pain after thoracic surgery
Measured: during the intraoperative phase, data relating to the surgical techniques performed are collected
Assessment of the post-operative quality of life based on the different surgical techniques in thoracic surgery
the aim of this objective is to analyze whether different surgical techniques (more or less invasive) play a role in the quality of life after thoracic surgery
Measured: during the intraoperative phase, data relating to the surgical techniques performed are collected
Evaluation of postoperative pain control based on different anesthesiological techniques and its possible correlation with the development of chronic pain
the aim of this objective is to analyze whether different anesthesiological techniques play a role in the onset of chronic or neuropathic pain after thoracic surgery. The techniques of locoregional anesthesia performed and the drugs used both during surgery and in the postoperative phase are analyzed
Measured: data relating to this objective are collected in the intraoperative, 24 hours after surgery and subsequent telephone interviews at 1 week, 1, 3 and 6 months after thoracic surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start25 Oct 2017
- Primary completionApr 2020 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Neuropathic 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 30 Months
Sponsor and investigators
- Lead sponsor
- University of Trieste
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marzia Umari, University of Trieste
- Investigators
- Umberto Lucangelo, MD PhD, Study director, University of TriesteMarzia Umari, MD, Principal investigator, University of Trieste
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04300660
- Sponsor's protocol ID
- N. ASUI TS 8/2017
- Acronym
- POPARTS
- Status last verified
- Mar 2020
- First submitted
- 1 Mar 2020
- Last updated
- 9 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Macrae WA. Chronic post-surgical pain: 10 years on. Br J Anaesth. 2008 Jul;101(1):77-86. doi: 10.1093/bja/aen099. Epub 2008 Apr 22.
PubMed 18434337Allegri M, Baron R, Hans G, Correa-Illanes G, Mayoral Rojals V, Mick G, Serpell M. A pharmacological treatment algorithm for localized neuropathic pain. Curr Med Res Opin. 2016;32(2):377-84. doi: 10.1185/03007995.2015.1129321.
PubMed 26641136Elmore B, Nguyen V, Blank R, Yount K, Lau C. Pain Management Following Thoracic Surgery. Thorac Surg Clin. 2015 Nov;25(4):393-409. doi: 10.1016/j.thorsurg.2015.07.005.
PubMed 26515940Maguire MF, Ravenscroft A, Beggs D, Duffy JP. A questionnaire study investigating the prevalence of the neuropathic component of chronic pain after thoracic surgery. Eur J Cardiothorac Surg. 2006 May;29(5):800-5. doi: 10.1016/j.ejcts.2006.02.002. Epub 2006 Apr 3.
PubMed 16581259Rizk NP, Ghanie A, Hsu M, Bains MS, Downey RJ, Sarkaria IS, Finley DJ, Adusumilli PS, Huang J, Sima CS, Burkhalter JE, Park BJ, Rusch VW. A prospective trial comparing pain and quality of life measures after anatomic lung resection using thoracoscopy or thoracotomy. Ann Thorac Surg. 2014 Oct;98(4):1160-6. doi: 10.1016/j.athoracsur.2014.05.028. Epub 2014 Jul 31.
PubMed 25086945Kinney MA, Mantilla CB, Carns PE, Passe MA, Brown MJ, Hooten WM, Curry TB, Long TR, Wass CT, Wilson PR, Weingarten TN, Huntoon MA, Rho RH, Mauck WD, Pulido JN, Allen MS, Cassivi SD, Deschamps C, Nichols FC, Shen KR, Wigle DA, Hoehn SL, Alexander SL, Hanson AC, Schroeder DR. Preoperative gabapentin for acute post-thoracotomy analgesia: a randomized, double-blinded, active placebo-controlled study. Pain Pract. 2012 Mar;12(3):175-83. doi: 10.1111/j.1533-2500.2011.00480.x. Epub 2011 Jun 16.
PubMed 21676165Gotoda Y, Kambara N, Sakai T, Kishi Y, Kodama K, Koyama T. The morbidity, time course and predictive factors for persistent post-thoracotomy pain. Eur J Pain. 2001;5(1):89-96. doi: 10.1053/eujp.2001.0225.
PubMed 11394926Khelemsky Y, Noto CJ. Preventing post-thoracotomy pain syndrome. Mt Sinai J Med. 2012 Jan-Feb;79(1):133-9. doi: 10.1002/msj.21286.
PubMed 22238046Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
PubMed 21479777Freynhagen R, Baron R, Gockel U, Tolle TR. painDETECT: a new screening questionnaire to identify neuropathic components in patients with back pain. Curr Med Res Opin. 2006 Oct;22(10):1911-20. doi: 10.1185/030079906X132488.
PubMed 17022849
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POPARTS Study- Post-Operative Pain After Recovery in Thoracic Surgery: Evaluation of the Persistence of Painful Symptoms and the Incidence of Neuropathic Pain After Resective Lung Surgery
- ClinicalTrials.gov ID
- NCT04300660
- Acronym / sponsor ID
- POPARTS / N. ASUI TS 8/2017
- Conditions
- Neuropathic Pain, Post Operative Pain, Thoracic Surgery
- Keywords
- thoracic surgery, analgesia, chest wall analgesia, Post-Thoracotomic Pain Syndrome, VATS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of TriesteUniversity, hospital or other
- Study start
- 25 Oct 2017 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 9 Mar 2020 (actual)
- 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.
Persistent pain after surgery has significant physical and mental consequences for the patient, as well as a significant economic impact on health systems. Neuropathic pain is caused by direct or indirect damage to the somatosensitive system. In thoracic surgery, chronic neuropathic pain is represented by Post-Thoracotomic Pain Syndrome (PTPS), defined as recurrent or persistent pain in the thoracotomy scar site that persists for more than 3-6 months. Currently, in literature, the prevalence of PTPS is extremely variable. This prospective observational study aims to assess the incidence of pain in the weeks and months following surgery and to assess whether and how the presence of painful symptoms changes the patient's quality of life.
Detailed description
For each patient enrolled in the study, in the pre-operative phase, comorbidities, any chronic analgesic therapy and quality of life (through a dedicated questionnaire - Euro QoL 5D5L1) will be recorded. Surgical data (type of procedure, lobe affected by resection, type of approach and surgical time) and anesthesiological data (intravenous opioid, locoregional technique (s), non-opioid analgesics administered and other medications) will be collected in the perioperative phase. In the 48 hours following the surgery (in the Recovery Room, at 6h, 12h, 24h, 36h and 48h) the patient's pain data will be recorded (static, dynamic and cough-associated NRS) and those relating to any complications. The total amount of morphine administered to the patient in the first 48 hours will also be recorded. Each patient will be evaluated 7 days, 1, 3 and 6 months after the surgery by telephone interview. In this last phase, the possible presence of pain and its characteristics will be assessed, especially if these meet the criteria of neuropathic pain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted at our surgical center who underwent elective lobectomy, segmentectomy or atypical resection surgery with a mini-thoracotomy approach or VATS.
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Patient's consent to the trial
- Candidate to resective lung surgery (lobectomy, segmentectomy, atypical resection) with minimally invasive approach (mini-thoracotomy with muscle sparing or video-assisted thoracic surgery, VATS)
Key exclusion criteria (5 listed)
- neurological and / or cognitive deficits
- inability to obtain informed consent
- surgeries that include wall resections (pleural, muscle, rib or nerve)
- pneumonectomy
- Previous thoracic surgery at the time of enrollment
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 |
|---|---|---|
| neuropathic pain after thoracic surgeryanalysis of perioperative factors implicated in the onset of postoperative pain after chest surgery and the incidence of neuropathic pain | Other | – |
Primary outcome
Incidence of persistent post-operative pain after thoracic surgery
Time frame: the data needed to analyze the incidence and characteristics of pain will be collected at 1 week after surgery
The incidence of static, dynamic and cough-associated pain is assessed through the numerical rate scale (NRS), by a telephone interview one week and one month after surgery. A questionnaire is submitted to the patient to analyze the characteristics of the pain and its possible impact on the patient's quality of life.
Incidence of persistent post-operative pain after thoracic surgery
Time frame: the data needed to analyze the incidence and characteristics of pain will be collected at 1 month after surgery
The incidence of static, dynamic and cough-associated pain is assessed through the numerical rate scale (NRS), by a telephone interview one week and one month after surgery. A questionnaire is submitted to the patient to analyze the characteristics of the pain and its possible impact on the patient's quality of life.
Incidence of Chronic Pain after thoracic surgery
Time frame: The data needed to analyze the presence of chronic pain will be collected at 3 months after surgery
The possible presence and incidence of chronic pain is assessed through a telephone interview three and six months after surgery.
Incidence of Chronic Pain after thoracic surgery
Time frame: The data needed to analyze the presence of chronic pain will be collected at 6 months after surgery
The possible presence and incidence of chronic pain is assessed through a telephone interview three and six months after surgery.
Presence of pain with typical features of neuropathic pain in the different phases of the postoperative course
Time frame: The data neede to analyze the presence of neuropathic pain will be collected at a week after the surgery
During each telephone interview the presence of neuropathic pain is assessed through a dedicated questionnaire (PainDetect Questionnaire) and the impact that this type of pain has on the patient's quality of life.
Presence of pain with typical features of neuropathic pain in the different phases of the postoperative course
Time frame: The data neede to analyze the presence of neuropathic pain will be collected at a month after the surgery
During each telephone interview the presence of neuropathic pain is assessed through a dedicated questionnaire (PainDetect Questionnaire) and the impact that this type of pain has on the patient's quality of life.
Presence of pain with typical features of neuropathic pain in the different phases of the postoperative course
Time frame: The data neede to analyze the presence of neuropathic pain will be collected at 3 months after the surgery
During each telephone interview the presence of neuropathic pain is assessed through a dedicated questionnaire (PainDetect Questionnaire) and the impact that this type of pain has on the patient's quality of life.
Presence of pain with typical features of neuropathic pain in the different phases of the postoperative course
Time frame: The data neede to analyze the presence of neuropathic pain will be collected at 6 months after the surgery
During each telephone interview the presence of neuropathic pain is assessed through a dedicated questionnaire (PainDetect Questionnaire) and the impact that this type of pain has on the patient's quality of life.
3 secondary outcomes
Assessment of the incidence of chronic pain based on the different surgical techniques in thoracic surgery
Time frame: during the intraoperative phase, data relating to the surgical techniques performed are collected
Assessment of the post-operative quality of life based on the different surgical techniques in thoracic surgery
Time frame: during the intraoperative phase, data relating to the surgical techniques performed are collected
Evaluation of postoperative pain control based on different anesthesiological techniques and its possible correlation with the development of chronic pain
Time frame: data relating to this objective are collected in the intraoperative, 24 hours after surgery and subsequent telephone interviews at 1 week, 1, 3 and 6 months after thoracic surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2020.
- Background: PubMed 18434337Macrae WA. Chronic post-surgical pain: 10 years on. Br J Anaesth. 2008 Jul;101(1):77-86. doi: 10.1093/bja/aen099. Epub 2008 Apr 22.
- Background: PubMed 26641136Allegri M, Baron R, Hans G, Correa-Illanes G, Mayoral Rojals V, Mick G, Serpell M. A pharmacological treatment algorithm for localized neuropathic pain. Curr Med Res Opin. 2016;32(2):377-84. doi: 10.1185/03007995.2015.1129321.
- Background: PubMed 26515940Elmore B, Nguyen V, Blank R, Yount K, Lau C. Pain Management Following Thoracic Surgery. Thorac Surg Clin. 2015 Nov;25(4):393-409. doi: 10.1016/j.thorsurg.2015.07.005.
- Background: PubMed 16581259Maguire MF, Ravenscroft A, Beggs D, Duffy JP. A questionnaire study investigating the prevalence of the neuropathic component of chronic pain after thoracic surgery. Eur J Cardiothorac Surg. 2006 May;29(5):800-5. doi: 10.1016/j.ejcts.2006.02.002. Epub 2006 Apr 3.
- Background: PubMed 25086945Rizk NP, Ghanie A, Hsu M, Bains MS, Downey RJ, Sarkaria IS, Finley DJ, Adusumilli PS, Huang J, Sima CS, Burkhalter JE, Park BJ, Rusch VW. A prospective trial comparing pain and quality of life measures after anatomic lung resection using thoracoscopy or thoracotomy. Ann Thorac Surg. 2014 Oct;98(4):1160-6. doi: 10.1016/j.athoracsur.2014.05.028. Epub 2014 Jul 31.
- Background: PubMed 21676165Kinney MA, Mantilla CB, Carns PE, Passe MA, Brown MJ, Hooten WM, Curry TB, Long TR, Wass CT, Wilson PR, Weingarten TN, Huntoon MA, Rho RH, Mauck WD, Pulido JN, Allen MS, Cassivi SD, Deschamps C, Nichols FC, Shen KR, Wigle DA, Hoehn SL, Alexander SL, Hanson AC, Schroeder DR. Preoperative gabapentin for acute post-thoracotomy analgesia: a randomized, double-blinded, active placebo-controlled study. Pain Pract. 2012 Mar;12(3):175-83. doi: 10.1111/j.1533-2500.2011.00480.x. Epub 2011 Jun 16.
- Background: PubMed 11394926Gotoda Y, Kambara N, Sakai T, Kishi Y, Kodama K, Koyama T. The morbidity, time course and predictive factors for persistent post-thoracotomy pain. Eur J Pain. 2001;5(1):89-96. doi: 10.1053/eujp.2001.0225.
- Background: PubMed 22238046Khelemsky Y, Noto CJ. Preventing post-thoracotomy pain syndrome. Mt Sinai J Med. 2012 Jan-Feb;79(1):133-9. doi: 10.1002/msj.21286.
- Background: PubMed 21479777Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
- Background: PubMed 17022849Freynhagen R, Baron R, Gockel U, Tolle TR. painDETECT: a new screening questionnaire to identify neuropathic components in patients with back pain. Curr Med Res Opin. 2006 Oct;22(10):1911-20. doi: 10.1185/030079906X132488.
- Individual participant dataSharing planned: No
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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.
Umberto Lucangelo, MD PhD study director
University of Trieste
Marzia Umari, MD principal investigator
University of Trieste
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuropathic Pain and Post Operative Pain, run by University of Trieste at 1 site in Italy.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 9 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marzia Umari, MD (3474688773 ext. +39, marzia.umari@asuits.sanita.fvg.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of persistent post-operative pain after thoracic surgery (time frame: the data needed to analyze the incidence and characteristics of pain will be collected at 1 week after surgery). The study lists 8 primary outcomes in all. 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 NCT04300660, which also lists 10 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 9 Mar 2020.