Sensory Changes Associated With Thoracic Surgery

NCT06420570 | Completed

• 1 other identifier: AC21136
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thoracic Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Acute post-operative pain experienced by the patient

  Days after thoracic surgery (at least 3 hours after chest drain removal)

Other Outcomes (1)

• The patient's mood

  Days after thoracic surgery (at least 3 hours after chest drain removal)

Interventions

Thoracic Surgery PROCEDURE

Patients will either undergo thoracic surgery, specifically thoracotomy (traditional method of chest surgery using a large surgical incision) or video-assisted thoracic surgery (minimally invasive method using video cameras)

Eligibility Criteria

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

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Lothian: collaborator

Study Sites (1)

Royal Infirmary of Edinburgh

Edinburgh, EH16 4SA, United Kingdom

Location

MeSH Terms

Interventions

Thoracic Surgical Procedures

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• R Peter Alston

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: May 20, 2024
• Study Start: January 19, 2022
• Primary Completion: August 19, 2022
• Study Completion: August 19, 2022
• Last Updated: May 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: One year after completion of study.

Locations

GB (1)