Incidence of Chronic Pain After Thoracotomy

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain; Thoracotomy; Postoperative Pain, Acute; Postoperative Pain, Chronic
• Intervention / Treatment: Procedure: Thoracotomy application

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Musa Zengin, MD; Phone Number: 903125677233; Email: musazengin@gmail.com
• Study Contact Backup: Name: Ali Alagoz, Assoc Prof; Phone Number: +903125677232; Email: mdalagoz@gmail.com

Study Locations

• Turkey
  • Ankara
    • Kecioren, Ankara, Turkey, 06000
      • Recruiting
      • Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital
      • Contact: Musa Zengin, MD; Phone Number: +903125677233; Email: musazengin@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients between the ages of 18-65 years, in the ASA I-II-III risk group, with a BMI between 18-35 kg/m2 and undergoing thoracotomy will be included in the study.

Patients under the age of 18 years and over the age of 65 years, with an ASA score of IV and above, with a BMI below 18 kg/m2 and above 35 kg/m2, who were operated under emergency conditions, and who received chronic pain treatment will be excluded from the study.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
• Investigators: Principal Investigator: Musa Zengin, MD, Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2021
• Primary Completion (Estimated): March 16, 2024
• Study Completion (Estimated): April 16, 2024

Study Registration Dates

• First Submitted: December 16, 2021
• First Submitted That Met QC Criteria: December 16, 2021
• First Posted (Actual): January 4, 2022

Study Record Updates

• Last Update Posted (Actual): August 29, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Postoperative Pain; Thoracotomy; Postoperative Pain, Acute; Postoperative Pain, Chronic
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Chronic Pain; Acute Pain
• Other Study ID Numbers: 2012-KAEK-15/2438

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No