Actively Recruiting
Affecting Factors for the Incidence of Chronic Pain After Mastectomy
Led by Ankara Etlik City Hospital · Updated on 2025-02-04
200
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Chronic post-mastectomy pain (CPMP) is a common and significant problem affecting many women after mastectomy surgery. It can severely impact quality of life, with up to 50% of patients experiencing this pain and about 10% having severe symptoms. Researchers are studying the factors that contribute to CPMP, such as age, treatment type, and pre-surgery pain, in order to better understand and prevent this condition. This study aims to identify these contributing factors to improve prevention and treatment strategies. This observational study focuses on women aged 18 to 80 undergoing elective mastectomy or mastectomy with axillary dissection under general anesthesia. The study evaluates various factors that may influence the development of chronic pain after breast cancer surgery. Participants will be monitored without receiving experimental treatments, and data will be collected on neuropathic symptoms and pain levels at multiple time points after surgery. Participants will be followed up at 3 and 6 months after surgery with assessments including the Self-leeds evaluation of neuropathic symptoms and signs as well as the Short Form 12 questionnaire to measure quality of life. Acute pain scores will also be recorded up to 24 hours post-operation. The study involves signing a consent form and agreeing to participate, with the aim of contributing valuable information to reduce chronic pain after mastectomy.
CONDITIONS
Brief Title
Affecting Factors for Chronic Pain After Mastectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between the ages of 18 and 80
- Body mass index (BMI) between 18 and 35 kg/m2
- ASA (American Society of Anesthesiologists) score I, II, or III
- Scheduled for elective mastectomy surgery
- Scheduled for elective mastectomy with axillary dissection surgery
- Planned to undergo general anesthesia
- Agree to participate and sign consent form
You will not qualify if you...
- Under 18 or over 80 years of age
- Do not want to participate in the study
- Have chronic pain or use chronic opioids
- Have alcohol, substance, or drug addiction
- History of previous mastectomy
- Limited cooperation due to dementia or psychiatric disorders
- Pregnant or breastfeeding
- Cannot communicate in their native language
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo elective mastectomy surgery to investigate factors affecting chronic pain after the procedure.
1 visit (in-person)
Duration - 6 months
Participants are monitored for acute pain up to 24 hours after surgery and assessed for chronic pain and quality of life at 3 and 6 months post-operation.
3 visits at 24 hours, 3 months, and 6 months (in-person)
Trial Site Locations
Total: 1 location
1
Ankara Etlik City Hospital
Ankara, Yenimahalle, Turkey (Türkiye), 06100
Actively Recruiting
Research Team
B
Berkant DEMİRAY, M.D.
M
Musa ZENGİN, Associate Professor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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