NCT04300660

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 25, 2017

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 9, 2020

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

March 9, 2020

Status Verified

March 1, 2020

Enrollment Period

2.4 years

First QC Date

March 1, 2020

Last Update Submit

March 4, 2020

Conditions

Neuropathic PainPost Operative PainThoracic Surgery

Keywords

thoracic surgeryanalgesiachest wall analgesiaPost-Thoracotomic Pain SyndromeVATS

Outcome Measures

Primary Outcomes (8)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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

    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

    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

    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

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted at our surgical center who underwent elective lobectomy, segmentectomy or atypical resection surgery with a mini-thoracotomy approach or VATS.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cattinara Hospital

Trieste, 34149, Italy

RECRUITING

Related Publications (10)

  • 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.

    PMID: 18434337BACKGROUND

  • Allegri 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.

    PMID: 26641136BACKGROUND

  • Elmore 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.

    PMID: 26515940BACKGROUND

  • Maguire 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.

    PMID: 16581259BACKGROUND

  • Rizk 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.

    PMID: 25086945BACKGROUND

  • Kinney 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.

    PMID: 21676165BACKGROUND

  • Gotoda 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.

    PMID: 11394926BACKGROUND

  • Khelemsky Y, Noto CJ. Preventing post-thoracotomy pain syndrome. Mt Sinai J Med. 2012 Jan-Feb;79(1):133-9. doi: 10.1002/msj.21286.

    PMID: 22238046BACKGROUND

  • Herdman 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.

    PMID: 21479777BACKGROUND

  • Freynhagen 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.

    PMID: 17022849BACKGROUND

MeSH Terms

Conditions

NeuralgiaPain, PostoperativeAgnosia

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesPerceptual DisordersNeurobehavioral Manifestations

Study Officials

  • Umberto Lucangelo, MD PhD

    University of Trieste

    STUDY DIRECTOR

  • Marzia Umari, MD

    University of Trieste

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marzia Umari, MD

CONTACT

3474688773marzia.umari@asuits.sanita.fvg.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 1, 2020

First Posted

March 9, 2020

Study Start

October 25, 2017

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

March 9, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)