## Protocol Section
### Identification Module
**NCT ID:** NCT06420570

**Brief Title:** Sensory Changes Associated With Thoracic Surgery

**Official Title:** Dysaesthesia Associated With Thoracic Surgery

#### Organization Study ID Info
**ID:** AC21136
#### Organization
**Class:** OTHER
**Full Name:** University of Edinburgh
### Status Module
#### Completion Date
**Date:** 2022-08-19

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-08-19

**Type:** ACTUAL

#### Start Date
**Date:** 2022-01-19

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2021-11-16
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER_GOV

**Name:** NHS Lothian

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Edinburgh

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Thoracic Surgery

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 14

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** 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)

**Name:** Thoracic Surgery

**Type:** PROCEDURE

### Outcomes Module

#### Other Outcomes

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

**Measure:** The patient's mood

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

#### Primary Outcomes

**Description:** 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.

**Measure:** Area of dysaesthesia on a patient's chest wall

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

#### Secondary Outcomes

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

**Measure:** Acute post-operative pain experienced by the patient

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

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

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

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Edinburgh

**Country:** United Kingdom

**Facility:** Royal Infirmary of Edinburgh

**Zip:** EH16 4SA

#### Overall Officials

**Official 1:**

**Affiliation:** University of Edinburgh

**Name:** R Peter Alston

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** The data will be shared if contacted by email.

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ICF

- CSR

**IPD Sharing:** YES

**Time Frame:** One year after completion of study.

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000094665

- Term: Dissection, Blood Vessel

- ID: D000000783

- Term: Aneurysm

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000094683

- Term: Acute Aortic Syndrome

- ID: D000001018

- Term: Aortic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M4114

- Name: Aortic Dissection

- Relevance: HIGH

- As Found: Thoracic

- ID: M3081

- Name: Dissection, Blood Vessel

- Relevance: LOW

- As Found: Unknown

- ID: M4113

- Name: Aneurysm

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M3085

- Name: Acute Aortic Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M4334

- Name: Aortic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000784

- Term: Aortic Dissection

### Misc Info Module

- Version Holder: 2024-05-31
