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Post-Operative Pain After Recovery in Thoracic Surgery

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04300660
Acronym
POPARTS
Enrollment
250
Registered
2020-03-09
Start date
2017-10-25
Completion date
2020-04-30
Last updated
2020-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuropathic Pain, Post Operative Pain, Thoracic Surgery

Keywords

thoracic surgery, analgesia, chest wall analgesia, Post-Thoracotomic Pain Syndrome, 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.

Interventions

OTHERneuropathic pain after thoracic surgery

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

Sponsors

University of Trieste
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of persistent post-operative pain after thoracic surgerythe data needed to analyze the incidence and characteristics of pain will be collected at 1 week after surgeryThe 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.
Incidence of Chronic Pain after thoracic surgeryThe data needed to analyze the presence of chronic pain will be collected at 3 months after surgeryThe possible presence and incidence of chronic pain is assessed through a telephone interview three and six months after surgery.
Presence of pain with typical features of neuropathic pain in the different phases of the postoperative courseThe data neede to analyze the presence of neuropathic pain will be collected at a week after the surgeryDuring 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.

Secondary

MeasureTime frameDescription
Assessment of the incidence of chronic pain based on the different surgical techniques in thoracic surgeryduring the intraoperative phase, data relating to the surgical techniques performed are collectedthe 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
Assessment of the post-operative quality of life based on the different surgical techniques in thoracic surgeryduring the intraoperative phase, data relating to the surgical techniques performed are collectedthe 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
Evaluation of postoperative pain control based on different anesthesiological techniques and its possible correlation with the development of chronic paindata 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 surgerythe 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

Countries

Italy

Contacts

Primary ContactMarzia Umari, MD
marzia.umari@asuits.sanita.fvg.it3474688773

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026