Predictors of Acute and Persistent Postoperative Pain in Lung Cancer Surgery

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Diagnostic test: Preoperative test

Detailed Description

This observational study examine acute and chronic postoperative pain in patients undergoing VATS. In the study preoperative biomarkers, quantitative sensory testing and questionnaires are used to create prediction models for acute and chronic postoperative pain. The study will serve as background information on the risk factors and predictive factors as well as an exploration of the impact of surgical stress from VATS on circulation microRNA and inflammatory mediators.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Denmark
  • Region Of Northern Jutland
    • Aalborg, Region Of Northern Jutland, Denmark, 9000
      • Aalborg University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Public University hospital

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients Undergoing VATS; Only one group as primary endpoints are continous	Diagnostic test: Preoperative test; Patients are subject to quantitative sensory testing, questionnaires, and biomarker analysis prior to surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total equipotent opioid dose	48 hours postoperative	Total equipotent opioid dose in milligrams during the first 48 hours after surgery.
Time to first administration of opioid	48 hours postoperative	Time in hours to first postoperative administration of Pro Re Nata (PRN) opioids
Mobilisation	Time in hours to full mobilisation defined as walking with or without aids.	48 hours postoperative
Patient-reported satisfaction of postoperative pain management assessed by self-made questionnaire in Danish	Patients are asked to fill out a questionnaire rating their general satisfaction with pain management and sufficiency of pain treatment on a scale from 0 to 10. The questionnaire also assess whether the patients had any perceived side effects and how uncomfortable they were on a scale from 0 to 10.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Examination of the level of inflammatory biomarkers (IL-6, IL-8, TNFa, etc.) and circulation microRNA	Change in expression of microRNA and Inflammatory mediators from before surgery until two days after surgery	48 hours postoperative

Collaborators and Investigators

• Sponsor: Jannie Bisgaard Stæhr
• Collaborators: Aalborg University
• Investigators: Principal Investigator: Jannie Bisagaard, MD, PhD, Aalborg University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): August 6, 2023
• Study Completion (Estimated): August 6, 2024

Study Registration Dates

• First Submitted: October 24, 2022
• First Submitted That Met QC Criteria: October 27, 2022
• First Posted (Actual): October 31, 2022

Study Record Updates

• Last Update Posted (Estimated): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Postoperative Complications; Pain; Neurologic Manifestations; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pain, Postoperative; Lung Neoplasms
• Other Study ID Numbers: AAUH-VATS-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No