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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06420570
Other study ID # AC21136
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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