Sensory Changes Associated With Thoracic Surgery

Thoracic Surgery Clinical Trial

Official title:

Dysaesthesia Associated With Thoracic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06420570
• Other study ID #: AC21136
• Status: Completed
• Start date: January 19, 2022
• Est. completion date: August 19, 2022

Study information

• Verified date: May 2024
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 19, 2022
• Est. primary completion date: August 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Dissection
• Thoracic Surgery

Intervention

Procedure:
• Thoracic Surgery
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)

Locations

Country	Name	City	State
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh

Sponsors (2)

Lead Sponsor	Collaborator
University of Edinburgh	NHS Lothian

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Primary	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	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)