Sensory Changes Associated With Thoracic Surgery

Dysaesthesia Associated With Thoracic Surgery

Many patients experience chronic pain after thoracic surgery and this is caused by nerve damage during surgery. Changes in skin sensation (dysaesthesia) is typically associated with chronic nerve pain.

We hypothesise that thoracic surgery causes sensory changes. Another hypothesis is that minimally invasive thoracic surgery using video cameras results in less nerve damage and so a smaller area of altered skin sensation, when compared to the traditional method of chest surgery using a large surgical incision. A final hypothesis is that the extent of nerve damage during surgery is associated with the severity of pain early after surgery.

This study is designed to compare the total areas of sensory changes after thoracic surgery on the operated side of the chest with that on the non-operated side of the chest. We also aim to identify the type, pattern, location and area of sensory changes associated with thoracic surgery, comparing the operated with the non-operated side of the chest. In addition, we aim to compare the total area of sensory changes between the traditional method of chest surgery and the minimally invasive method of chest surgery. We would also like to determine whether the severity of pain early after surgery is associated with the area of sensory changes.

Study Overview

• Status: Completed
• Conditions: Thoracic Surgery
• Intervention / Treatment: Procedure: Thoracic Surgery

• Study Type: Observational
• Enrollment (Actual): 14

Contacts and Locations

Study Locations

• United Kingdom
  • Edinburgh, United Kingdom, EH16 4SA
    • Royal Infirmary of Edinburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients will be identified from the thoracic surgery operative list at the Royal Infirmary of Edinburgh.

Description

Inclusion Criteria:

• Patients 18 years old or older admitted for elective thoracic surgery

Exclusion Criteria:

• Emergency thoracic surgery
• Thoracic surgery involving sternotomy
• Damage to the spinal cord and/ or intercostal nerves prior to surgery
• Neurological diseases that may alter the skin sensation to the chest wall such as multiple sclerosis and neuropathies, previous surgery of chest wall, a history of chronic pain

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area of dysaesthesia on a patient's chest wall	Areas of dysaesthesia will be detected by applying von frey hair and a sterile, manually blunted 20g hypodermic needle on the patient's chest and back whilst asking the patient to report any sensory changes. The areas of dysaesthesia will be marked on chest using different coloured pens for different types of dysaesthesia. The non-operated side of the chest will act as a control. Tracing paper of known weight per unit area will be cut to the same size and shape as the areas of dysaesthesia. Areas of dysaesthesia will be estimated after placing the tracing paper on a sensitive weight scale.	Days after thoracic surgery (at least 3 hours after chest drain removal)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute post-operative pain experienced by the patient	This will be measured using a verbal rating scale: no pain, 0; mild pain, 1; moderate pain, 2; severe pain, 3.	Days after thoracic surgery (at least 3 hours after chest drain removal)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The patient's mood	This will be assessed by asking the patient to complete a hospital anxiety and depression questionnaire.	Days after thoracic surgery (at least 3 hours after chest drain removal)

Collaborators and Investigators

• Sponsor: University of Edinburgh
• Collaborators: NHS Lothian
• Investigators: Principal Investigator: R Peter Alston, University of Edinburgh

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2022
• Primary Completion (Actual): August 19, 2022
• Study Completion (Actual): August 19, 2022

Study Registration Dates

• First Submitted: November 16, 2021
• First Submitted That Met QC Criteria: May 14, 2024
• First Posted (Actual): May 20, 2024

Study Record Updates

• Last Update Posted (Actual): May 20, 2024
• Last Update Submitted That Met QC Criteria: May 14, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aortic Diseases; Dissection, Blood Vessel; Acute Aortic Syndrome; Aortic Dissection
• Other Study ID Numbers: AC21136

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be shared if contacted by email.
• IPD Sharing Time Frame: One year after completion of study.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

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