Postoperative PainNCT05145153
Incidence of Chronic Pain After Thoracic Surgery
An observational study of Postoperative Pain and Postoperative Pain, Acute, run by Atatürk Chest Diseases and Chest Surgery Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain, Postoperative Pain, Acute, Postoperative Pain, Chronic
- What is being tested?
- Thoracic surgery application
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Sep 2021to 28 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Advanced cancer
- History of chronic analgesic therapy
- Patients with previous thoracic surgery
- Patients who were operated under emergency conditions
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital
Keçiören, Ankara, 06000
Musa Zengin, MD, +903125677233, musazengin@gmail.com
About this study
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.
- Conditions
- Postoperative Pain, Postoperative Pain, Acute, Postoperative Pain, Chronic, Video-Assisted Thoracoscopic Surgery, Thoracotomy
- Being tested
- Thoracic surgery application
- Keywords
- Postoperative Pain, Postoperative Pain, Acute, Postoperative Pain, Chronic, Video-Assisted Thoracoscopic Surgery, Thoracotomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic surgery applicationProcedure or surgery
The chronic pain findings of the patients who underwent thoracic surgery will be questioned at the postoperative 3rd and 6th months.
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores 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.
Measured: Chronic pain symptoms at 3th months.
Pain scores 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.
Measured: Chronic pain symptoms at 6th months.
Secondary outcomes (1)
Life quality
It will be questioned whether chronic pain affects the patient's quality of life.
- has no affect
- has little effect
- has medium affect
- has a lot of affects
Measured: The effect of chronic pain on quality of life at 3rd and 6th months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start28 Sep 2021
- Primary completion8 Oct 2024 (estimated)
- Study completion28 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Musa Zengin, Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
- Investigators
- Musa Zengin, MD, Principal investigator, Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05145153
- Sponsor's protocol ID
- 2012-KAEK-15/2378
- Status last verified
- May 2024
- First submitted
- 18 Nov 2021
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Chronic Pain After Thoracic Surgery
- ClinicalTrials.gov ID
- NCT05145153
- Acronym / sponsor ID
- 2012-KAEK-15/2378
- Conditions
- Postoperative Pain, Postoperative Pain, Acute, Postoperative Pain, Chronic, Video-Assisted Thoracoscopic Surgery, Thoracotomy
- Keywords
- Postoperative Pain, Postoperative Pain, Acute, Postoperative Pain, Chronic, Video-Assisted Thoracoscopic Surgery, Thoracotomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Atatürk Chest Diseases and Chest Surgery Training and Research HospitalUniversity, hospital or other
- Study start
- 28 Sep 2021 (actual)
- Primary completion
- 8 Oct 2024 (estimated)
- Study completion
- 28 Nov 2024 (estimated)
- First posted
- 6 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Advanced cancer
- History of chronic analgesic therapy
- Patients with previous thoracic surgery
- Patients who were operated under emergency conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracic surgery applicationThe chronic pain findings of the patients who underwent thoracic surgery will be questioned at the postoperative 3rd and 6th months. | Procedure or surgery | – |
Primary outcome
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.
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.
1 secondary outcome
Life quality
Time frame: The effect of chronic pain on quality of life at 3rd and 6th months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Musa Zengin, MD principal investigator
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain and Postoperative Pain, Acute, run by Atatürk Chest Diseases and Chest Surgery Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Musa Zengin, MD (903125677233, musazengin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scores at 3th months. (time frame: Chronic pain symptoms at 3th months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2024.