Postoperative PainNCT05357963
Incidence of Chronic Pain After Sternotomy
An observational study of Postoperative Pain and Postoperative Pain, Acute, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Chronic postoperative pain is a well-known problem. Chronic postoperative pain is defined as pain that begins following a surgical procedure and persists for more than 2 months without other obvious causes such as infection or underlying disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pain, Postoperative Pain, Acute, Postoperative Pain, Chronic
- What is being tested?
- Sternotomy application
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2022to 5 Feb 2026
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients between the ages of 18-80 years, in the ASA I-II-III-IV risk group, with a BMI between 18-35 kg/m2 and undergoing sternotomy will be included in the study. Patients under the age of 18 years and over the age of 80 years, with an ASA score of V 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 80 years
- American Society of Anesthesiologists' physical status I-II-III-IV
- Body mass index (BMI) between 18-35 kg/m2
- Patients undergoing elective sternotomy
Who cannot join
- History of chronic analgesic therapy
- Patients with previous sternotomy surgery
- Patients who were operated under emergency conditions
Trial locations and contacts
1 site in 1 country.
About this study
Chronic postoperative pain is a well-known problem. Chronic postoperative pain is defined as pain that begins following a surgical procedure and persists for more than 2 months without other obvious causes such as infection or underlying disease. Sternotomy causes significant postoperative pain, and patients with chronic pain after sternotomy are often referred to pain clinics. The incidence of chronic pain after sternotomy ranges from 17% to 56%; In approximately one-third of these patients, chronic pain after sternotomy can compromise their quality of life by affecting their sleep patterns and impairing their ability to work. However, epidemiological studies on chronic pain after sternotomy are scarce. The aim of this study is to examine the incidence and possible risk factors of chronic pain following sternotomy operations. In this study, it was aimed to analyze the chronic pain findings of the patients who underwent sternotomy in the postoperative 3rd month.
- Being tested
- Sternotomy application
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sternotomy applicationProcedure or surgery
The chronic pain findings of the patients who underwent sternotomy will be questioned at the postoperative 3rd month.
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic pain symptoms at 3rd months.
Chronic pain symptoms will be assessed using the numeric rating scale on a scale from 0 (no pain) to 10 (worst pain). Chronic 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 at the 3rd month after surgery.
Measured: Chronic pain symptoms at 3rd month
Quality of life at 3rd months.
It will also be questioned whether the current pain of the patients affects their daily activities. It will be coded as '0 = not at all, 1 = slightly affecting, 2 = very affecting'.
Measured: Quality of life at 3rd months.
Secondary outcomes (1)
Acute pain score
Pain will be assessed at rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Pain assessment will be done at the 24th hour after surgery.
Measured: At the 24th hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start20 Apr 2022
- Primary completion5 Nov 2025
- Study completion5 Feb 2026
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 (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilgün Zengin, Ankara City Hospital Bilkent
- Investigators
- Nilgün ZENGİN, MD, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05357963
- Sponsor's protocol ID
- E.Kurul-E1-22-2595
- Status last verified
- Mar 2026
- First submitted
- 25 Apr 2022
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Chronic Pain After Sternotomy
- ClinicalTrials.gov ID
- NCT05357963
- Acronym / sponsor ID
- E.Kurul-E1-22-2595
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 5 Nov 2025 (actual)
- Study completion
- 5 Feb 2026 (actual)
- First posted
- 3 May 2022 (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.
Chronic postoperative pain is a well-known problem. Chronic postoperative pain is defined as pain that begins following a surgical procedure and persists for more than 2 months without other obvious causes such as infection or underlying disease. Sternotomy causes significant postoperative pain, and patients with chronic pain after sternotomy are often referred to pain clinics. The incidence of chronic pain after sternotomy ranges from 17% to 56%; In approximately one-third of these patients, chronic pain after sternotomy can compromise their quality of life by affecting their sleep patterns and impairing their ability to work. However, epidemiological studies on chronic pain after sternotomy are scarce. The aim of this study is to examine the incidence and possible risk factors of chronic pain following sternotomy operations. In this study, it was aimed to analyze the chronic pain findings of the patients who underwent sternotomy in the postoperative 3rd month.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients between the ages of 18-80 years, in the ASA I-II-III-IV risk group, with a BMI between 18-35 kg/m2 and undergoing sternotomy will be included in the study. Patients under the age of 18 years and over the age of 80 years, with an ASA score of V 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 80 years
- American Society of Anesthesiologists' physical status I-II-III-IV
- Body mass index (BMI) between 18-35 kg/m2
- Patients undergoing elective sternotomy
Key exclusion criteria (3 listed)
- History of chronic analgesic therapy
- Patients with previous sternotomy 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 |
|---|---|---|
| Sternotomy applicationThe chronic pain findings of the patients who underwent sternotomy will be questioned at the postoperative 3rd month. | Procedure or surgery | – |
Primary outcome
Chronic pain symptoms at 3rd months.
Time frame: Chronic pain symptoms at 3rd month
Chronic pain symptoms will be assessed using the numeric rating scale on a scale from 0 (no pain) to 10 (worst pain). Chronic 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 at the 3rd month after surgery.
Quality of life at 3rd months.
Time frame: Quality of life at 3rd months.
It will also be questioned whether the current pain of the patients affects their daily activities. It will be coded as '0 = not at all, 1 = slightly affecting, 2 = very affecting'.
1 secondary outcome
Acute pain score
Time frame: At the 24th hour after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
Related trials for Postoperative Pain
Active, not recruiting
Dance Study for Post-surgical Pain in Breast Cancer Survivors
Breast Cancer, Survivorship
RecruitingPhase 2/3
Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children
Pain, Postoperative
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Active, not recruiting
Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty
Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
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.
Nilgün ZENGİN, MD principal investigator
Ankara City Hospital Bilkent
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 Ankara City Hospital Bilkent 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 3 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: finished, as of the sponsor's last update on 9 Mar 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic pain symptoms at 3rd months. (time frame: Chronic pain symptoms at 3rd month). 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 9 Mar 2026.