- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05357963
Incidence of Chronic Pain After Sternotomy
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ankara
-
Çankaya, Ankara, Turkey (Türkiye), 06290
- Ankara City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- History of chronic analgesic therapy
- Patients with previous sternotomy surgery
- Patients who were operated under emergency conditions
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Chronic pain symptoms at 3rd month
|
|
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'.
|
Quality of life at 3rd months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acute pain score
Time Frame: At the 24th hour after surgery
|
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.
|
At the 24th hour after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nilgün ZENGİN, MD, Ankara City Hospital Bilkent
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E.Kurul-E1-22-2595
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postoperative Pain
-
National and Kapodistrian University of AthensCompletedPostoperative Pain, Acute | Postoperative Pain, Chronic | Postoperative Pain After Thoracic SurgeryGreece
-
Second Affiliated Hospital, School of Medicine,...Not yet recruitingPostoperative Pain | Postoperative Pain Management | Postoperative Pain in Orthopaedics
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Aydin Adnan Menderes UniversityCompleted
-
Aydin Adnan Menderes UniversityCompletedAcute Postoperative Pain | Chronic Postoperative PainTurkey
-
Children's National Research InstituteVentureWellRecruitingPostoperative Pain | Acute Pain | Acute Pain, PostoperativeUnited States
-
University of MalayaActive, not recruitingPostoperative Pain | Postoperative Pain ManagementMalaysia
-
Maimonides Medical CenterCompletedPOSTOPERATIVE PAINUnited States
-
University Hospital, AntwerpUnknown
Clinical Trials on Sternotomy application
-
China National Center for Cardiovascular DiseasesPeking University International Hospital; Beijing Shijitan Hospital, Capital... and other collaboratorsNot yet recruitingMultivessel Coronary Artery Disease | Coronary Artery Bypass Grafting | Complete Revascularization
-
Tomsk Cardiology Research InstituteRecruiting
-
Assiut UniversityUnknown
-
Fundación Pública Andaluza para la Investigación...CompletedAortic Valve Stenosis | Aortic Valve Disease | Heart Valve DiseasesSpain
-
University of Cape TownMedical Research Council, South AfricaCompletedHeart InjuriesSouth Africa
-
Ospedale San RaffaeleCompleted
-
Peking University Third HospitalNot yet recruitingMinimally Invasive Cardiac Surgery
-
Cliniques universitaires Saint-Luc- Université...Completed
-
Ankara Etlik City HospitalRecruitingPain, Acute | Cardiac Surgery | Pain, Chronic | SternotomyTurkey