Predictors of Acute and Persistent Postoperative Pain in Lung Cancer Surgery

NCT05599386 | Unknown

• 1 other identifier: AAUH-VATS-02
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this observational study is to investigate if preoperative quantitative sensory testing, anxiety and depression symptoms, and biological markers are associated with the risk of developing acute and chronic postoperative pain after video-assisted Thoracoscopic surgery (VATS).

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Numerical Rating Scale

  Pain intensity on a Numerical Rating Scale ranging from 0 indicating no pain to 10 indicating worst pain imaginable during the first two postoperative days.

  48 hours postoperative

• Numerical Rating Scale

  Pain intensity on a Numerical Rating Scale ranging from 0 indicating no pain to 10 indicating worst pain imaginable at follow up. Collected using the Brief Pain Index

  365 days postoperative

Secondary Outcomes (4)

• Total equipotent opioid dose

  Total equipotent opioid dose in milligrams during the first 48 hours after surgery.

• Time to first administration of opioid

  Time in hours to first postoperative administration of Pro Re Nata (PRN) opioids

• Mobilisation

  48 hours postoperative

• Patient-reported satisfaction of postoperative pain management assessed by self-made questionnaire in Danish

  Measured twice. Once 48 hours after surgery or at non fixed time(on average 4 days and a maximum of 3 months) as well as at 365 days

Other Outcomes (1)

• Examination of the level of inflammatory biomarkers (IL-6, IL-8, TNFa, etc.) and circulation microRNA

  48 hours postoperative

Study Arms (1)

Patients Undergoing VATS

Only one group as primary endpoints are continous

Diagnostic Test: Preoperative test

Interventions

Preoperative test DIAGNOSTIC_TEST

Patients are subject to quantitative sensory testing, questionnaires, and biomarker analysis prior to surgery.

Patients Undergoing VATS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Public University hospital

You may qualify if:

• Adults independent of sex with an age of ≥ 18 years
• Patients scheduled for VATS as a part of either examination or radical treatment of lung cancer

You may not qualify if:

• Patients who are unable to understand oral and written information.
• Patients with known chronic pain in the thorax which have been persisting for at least six months before the day of surgery.
• Pregnant and nursing women.
• Patients receiving a planned preoperative epidural blockade during their stay.
• Patients converted to open surgery.

Sponsors & Collaborators

• Jannie Bisgaard Stæhr: lead
• Aalborg University: collaborator

Study Sites (1)

Aalborg University Hospital

Aalborg, Region of Northern Jutland, 9000, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jannie Bisagaard, MD, PhD

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: October 31, 2022
• Study Start: November 1, 2022
• Primary Completion: August 6, 2023
• Study Completion: August 6, 2024
• Last Updated: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)