Predictors of Acute and Persistent Postoperative Pain in Lung Cancer Surgery

Active, not recruiting

• Conditions: Lung Cancer
• Interventions: Diagnostic Test: Preoperative test

• Registration Number: NCT05599386
• Lead Sponsor: Jannie Bisgaard Stæhr

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).

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 Timeline

• Study First Submitted: 2022-10-24
• Study First Submitted QC: 2022-10-27
• Study First Posted: 2022-10-31
• Study Start: 2022-11-01
• Primary Completion: 2023-08-06
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-07
• Last Update Posted: 2023-12-08
• Study Completion: 2024-08-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients Undergoing VATS	Preoperative test	Only one group as primary endpoints are continous

Primary Outcome Measures

Name	Time	Method
Numerical Rating Scale	365 days postoperative	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

Secondary Outcome Measures

Name	Time	Method
Total equipotent opioid dose	Total equipotent opioid dose in milligrams during the first 48 hours after surgery.	48 hours postoperative
Time to first administration of opioid	Time in hours to first postoperative administration of Pro Re Nata (PRN) opioids	48 hours postoperative
Mobilisation	48 hours postoperative	Time in hours to full mobilisation defined as walking with or without aids.
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	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.

Trial Locations

Locations (1)

Aalborg University Hospital; 🇩🇰 Aalborg, Region Of Northern Jutland, Denmark