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OpenTrials
Completed

NCT Number: NCT06420570

Sensory Changes 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.

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Key information

Conditions

Thoracic Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Infirmary of Edinburgh

Edinburgh, EH16 4SA, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. Area of dysaesthesia on a patient's chest wall

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

    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.

Secondary outcomes

  1. Acute post-operative pain experienced by the patient

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

    This will be measured using a verbal rating scale: no pain, 0; mild pain, 1; moderate pain, 2; severe pain, 3.

Other outcomes

  1. The patient's mood

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

    This will be assessed by asking the patient to complete a hospital anxiety and depression questionnaire.

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • NHS Lothian

Registry information

Official study title

Dysaesthesia Associated With Thoracic Surgery

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 20, 2024
Registry last updated
May 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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