Post-Operative Pain After Recovery in Thoracic Surgery

Neuropathic Pain Clinical Trial

— POPARTS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04300660
• Other study ID #: N. ASUI TS 8/2017
• Status: Recruiting
• Start date: October 25, 2017
• Est. completion date: April 2020

Study information

• Verified date: March 2020
• Source: University of Trieste
• Contact: Marzia Umari, MD
• Phone: 3474688773
• Email: marzia.umari[@]asuits.sanita.fvg.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: April 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain
• Pain, Postoperative
• Post Operative Pain
• Thoracic Surgery

Intervention

Other:
• neuropathic pain after thoracic surgery
analysis of perioperative factors implicated in the onset of postoperative pain after chest surgery and the incidence of neuropathic pain

Locations

Country	Name	City	State
Italy	Cattinara Hospital	Trieste

Sponsors (1)

Lead Sponsor	Collaborator
University of Trieste

Country where clinical trial is conducted

Italy, 

References & Publications (10)

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. — View Citation

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. Review. — View Citation

Freynhagen R, Baron R, Gockel U, Tölle 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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. Epub 2006 Apr 3. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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	during the intraoperative phase, data relating to the surgical techniques performed are collected
Secondary	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	during the intraoperative phase, data relating to the surgical techniques performed are collected
Secondary	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	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