Post-Operative Pain After Recovery in Thoracic Surgery

Last updated: March 4, 2020
Sponsor: University of Trieste
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pain

Spinal Surgery

Acute Pain

Treatment

N/A

Clinical Study ID

NCT04300660
N. ASUI TS 8/2017
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 orvideo-assisted thoracic surgery, VATS)

Exclusion

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

Study Design

Total Participants: 250
Study Start date:
October 25, 2017
Estimated Completion Date:
April 30, 2020

Study 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.

Connect with a study center

  • Cattinara Hospital

    Trieste, 34149
    Italy

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.