Post-Operative Pain After Recovery in Thoracic Surgery

NCT ID: NCT04300660

Last Updated: 2020-03-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-10-25
• Study Completion Date: 2020-04-30

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Trieste

OTHER

Sponsor Role: lead

Responsible Party

Marzia Umari

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Umberto Lucangelo, MD PhD

Role: STUDY_DIRECTOR

University of Trieste

Marzia Umari, MD

Role: PRINCIPAL_INVESTIGATOR

University of Trieste

Locations

Cattinara Hospital

Trieste, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Marzia Umari, MD

Role: CONTACT

marzia.umari@asuits.sanita.fvg.it

3474688773 ext. +39

Facility Contacts

Marzia Umari, MD

Role: primary

marzia.umari@asuits.sanita.fvg.it

347 4688773 ext. +39

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Other Identifiers

N. ASUI TS 8/2017

Identifier Type: -

Identifier Source: org_study_id