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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05177575
Other study ID # 2012-KAEK-15/2438
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 16, 2021
Est. completion date April 16, 2024

Study information

Verified date August 2023
Source Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
Contact Musa Zengin, MD
Phone 903125677233
Email musazengin@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Thoracotomy is frequently performed in thoracic surgery. It is widely accepted that thoracotomy causes severe acute pain. Many factors such as postoperative analgesia treatment plan, operation time, number of chest tubes, and duration of chest tube stay can affect acute pain. This acute pain prolongs the discharge time of the patients and increases the frequency of postoperative pulmonary complications and postoperative morbidity. Postoperative acute pain may cause chronic thoracotomy pain in the later period, and may adversely affect the quality of life of the patients. This study aims to analyze the symptoms of chronic pain in the 3rd and 6th months postoperatively in patients who had undergone thoracotomy.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date April 16, 2024
Est. primary completion date March 16, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Age between 18 and 65 years - American Society of Anesthesiologists physical status I-II-III - Body mass index (BMI) between 18-35 kg/m2 - Patients undergoing elective thoracotomy Exclusion Criteria: - Advanced cancer - History of chronic analgesic therapy - Patients with previous thoracic surgery - Patients who were operated under emergency conditions

Study Design


Intervention

Procedure:
Thoracotomy application
The chronic pain findings of the patients who underwent thoracotomy will be questioned at the postoperative 3rd and 6th months.

Locations

Country Name City State
Turkey Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital Kecioren Ankara

Sponsors (1)

Lead Sponsor Collaborator
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Chronic pain symptoms at 3rd months. Chronic pain symptoms will be assessed using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Neuropathic pain symptoms (burning, stabbing, electric shock-like pain, tingling, numbness, pins, and needles feeling, hyperalgesia, allodynia, and hypoesthesia) will also be asked to the patients in the 3rd month after surgery. Chronic pain symptoms at 3rd months.
Primary Chronic pain symptoms at 6th months. Chronic pain symptoms will be assessed using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Neuropathic pain symptoms (burning, stabbing, electric shock-like pain, tingling, numbness, pins, and needles feeling, hyperalgesia, allodynia, and hypoesthesia) will also be asked to the patients in the 6th month after surgery. Chronic pain symptoms at 6th months.
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