Predictors of Acute and Persistent Postoperative Pain in Lung Cancer Surgery

Lung Cancer Clinical Trial

Official title:

Predictors of Acute and Persistent Postoperative Pain in Lung Cancer Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05599386
• Other study ID #: AAUH-VATS-02
• Status: Active, not recruiting
• Start date: November 1, 2022
• Est. completion date: August 6, 2024

Study information

• Verified date: December 2023
• Source: Aalborg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: August 6, 2024
• Est. primary completion date: August 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Pain, Postoperative

Intervention

Diagnostic Test:
• Preoperative test
Patients are subject to quantitative sensory testing, questionnaires, and biomarker analysis prior to surgery.

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg	Region Of Northern Jutland

Sponsors (2)

Lead Sponsor	Collaborator
Jannie Bisgaard Stæhr	Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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	Total equipotent opioid dose	48 hours postoperative	Total equipotent opioid dose in milligrams during the first 48 hours after surgery.
Secondary	Time to first administration of opioid	48 hours postoperative	Time in hours to first postoperative administration of Pro Re Nata (PRN) opioids
Secondary	Mobilisation	Time in hours to full mobilisation defined as walking with or without aids.	48 hours postoperative
Secondary	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