Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Incidence of Chronic Pain After Thoracic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05145153
Recruitment Status : Recruiting
First Posted : December 6, 2021
Last Update Posted : December 6, 2021
Sponsor:
Information provided by (Responsible Party):
Musa Zengin, Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

Brief Summary:

Thoracotomy and video-assisted thoracic surgery procedures are frequently performed in thoracic surgery. It is widely accepted that thoracotomy causes severe acute pain. This 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. Video-assisted thoracic surgery (VATS) has become the standard procedure in minor and major lung surgeries. Postoperative pain is seen in patients undergoing VATS, although it is not as severe as after thoracotomy. As in thoracotomy, this affects the postoperative pulmonary complications and the discharge time of the patients. Likewise, this pain can cause chronic pain.

In this study, it was aimed to analyze the symptoms of chronic pain in the 3rd and 6th months postoperatively in patients who had undergone thoracic surgery.


Condition or disease Intervention/treatment
Postoperative Pain Postoperative Pain, Acute Postoperative Pain, Chronic Video-Assisted Thoracoscopic Surgery Thoracotomy Procedure: Thoracic surgery application

Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Incidence of Chronic Pain After Thoracic Surgery
Actual Study Start Date : September 28, 2021
Estimated Primary Completion Date : September 28, 2022
Estimated Study Completion Date : October 28, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain


Intervention Details:
  • Procedure: Thoracic surgery application
    The chronic pain findings of the patients who underwent thoracic surgery will be questioned at the postoperative 3rd and 6th months.


Primary Outcome Measures :
  1. Pain scores at 3th months. [ Time Frame: Chronic pain symptoms at 3th months. ]
    Choronic 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.

  2. Pain scores at 6th months. [ Time Frame: Chronic pain symptoms at 6th months. ]
    Choronic 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.


Secondary Outcome Measures :
  1. Life quality [ Time Frame: The effect of chronic pain on quality of life at 3rd and 6th months. ]

    It will be questioned whether chronic pain affects the patient's quality of life.

    1. has no affect
    2. has little effect
    3. has medium affect
    4. has a lot of affects



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 thoracic surgery will be included in our 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.

Criteria

Inclusion Criteria:

  • Age between 18 and 65 years
  • American Society of Anesthesiologists physical status I-II-III
  • Body mass index between 18-35 kg/m2
  • Patients undergoing elective thoracic surgery

Exclusion Criteria:

  • Advanced cancer
  • History of chronic analgesic therapy
  • Patients with previous thoracic surgery
  • Patients who were operated under emergency conditions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05145153


Contacts
Layout table for location contacts
Contact: Musa Zengin, MD 903125677233 musazengin@gmail.com
Contact: Ali Alagoz, Assoc Prof +903125677232 mdalagoz@gmail.com

Locations
Layout table for location information
Turkey
Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital Recruiting
Kecioren, Ankara, Turkey, 06000
Contact: Musa Zengin, MD    +903125677233    musazengin@gmail.com   
Sponsors and Collaborators
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
Investigators
Layout table for investigator information
Principal Investigator: Musa Zengin, MD Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
Layout table for additonal information
Responsible Party: Musa Zengin, Principal İnvestigator, Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
ClinicalTrials.gov Identifier: NCT05145153    
Other Study ID Numbers: 2012-KAEK-15/2378
First Posted: December 6, 2021    Key Record Dates
Last Update Posted: December 6, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Musa Zengin, Atatürk Chest Diseases and Chest Surgery Training and Research Hospital:
Postoperative Pain
Postoperative Pain, Acute
Postoperative Pain, Chronic
Video-Assisted Thoracoscopic Surgery
Thoracotomy
Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Chronic Pain
Acute Pain
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations