Clinical trial NCT04300660: Post-Operative Pain After Recovery in Thoracic Surgery
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neuropathic Pain
Post Operative Pain
Thoracic Surgery
Keywords: thoracic surgery
analgesia
chest wall analgesia
Post-Thoracotomic Pain Syndrome
VATS
Lead sponsor: University of Trieste
Sponsor class: OTHER
First posted: 2020-03-09
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.

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

Primary outcomes:
measure: Incidence of persistent post-operative pain after thoracic surgery
timeFrame: the data needed to analyze the incidence and characteristics of pain will be collected at 1 week after surgery
measure: Incidence of persistent post-operative pain after thoracic surgery
timeFrame: the data needed to analyze the incidence and characteristics of pain will be collected at 1 month after surgery
measure: Incidence of Chronic Pain after thoracic surgery
timeFrame: The data needed to analyze the presence of chronic pain will be collected at 3 months after surgery
measure: Incidence of Chronic Pain after thoracic surgery
timeFrame: The data needed to analyze the presence of chronic pain will be collected at 6 months after surgery
measure: Presence of pain with typical features of neuropathic pain in the different phases of the postoperative course
timeFrame: The data neede to analyze the presence of neuropathic pain will be collected at a week after the surgery
measure: Presence of pain with typical features of neuropathic pain in the different phases of the postoperative course
timeFrame: The data neede to analyze the presence of neuropathic pain will be collected at a month after the surgery
measure: Presence of pain with typical features of neuropathic pain in the different phases of the postoperative course
timeFrame: The data neede to analyze the presence of neuropathic pain will be collected at 3 months after the surgery
measure: Presence of pain with typical features of neuropathic pain in the different phases of the postoperative course
timeFrame: The data neede to analyze the presence of neuropathic pain will be collected at 6 months after the surgery
Secondary outcomes:
measure: Assessment of the incidence of chronic pain based on the different surgical techniques in thoracic surgery
timeFrame: during the intraoperative phase, data relating to the surgical techniques performed are collected
measure: Assessment of the post-operative quality of life based on the different surgical techniques in thoracic surgery
timeFrame: during the intraoperative phase, data relating to the surgical techniques performed are collected
measure: Evaluation of postoperative pain control based on different anesthesiological techniques and its possible correlation with the development of chronic pain
timeFrame: 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
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: Cattinara Hospital
Study officials:
affiliation: University of Trieste
name: Umberto Lucangelo, MD PhD
role: STUDY_DIRECTOR
affiliation: University of Trieste
name: Marzia Umari, MD
role: PRINCIPAL_INVESTIGATOR
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