Clinical trial NCT06592053: Affecting Factors for Chronic Pain After Mastectomy
Official title: Affecting Factors for the Incidence of Chronic Pain After Mastectomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mastectomy
Pain, Chronic
Pain, Acute
Breast Surgery
Breast Cancer Surgery
Lead sponsor: Ankara Etlik City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-09-19
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged 18-80 years, with an ASA classification of I-II-III and a body mass index (BMI) between 18-35 kg/m², who will undergo mastectomy surgery or mastectomy with axillary dissection, will be included in our study.

Brief summary: Chronic post-mastectomy pain (CPMP) is a significant issue affecting many women after mastectomy. Factors like age, treatment type, and pre-surgery pain can increase the risk of developing this condition. By evaluating these factors, CPMP can be prevented more successfully and treatment strategies can be developed. This study aims to investigate the factors contributing to CPMP and contribute to the existing literature on this important topic.

Detailed description: Chronic post-mastectomy pain (CPMP) is a common condition and is a significant clinical problem with a prevalence reported in the literature of up to 50%. Approximately 10% of patients experience severe pain, which has a significant impact on their quality of life. Since mastectomy is a frequently performed procedure, this syndrome affects a large number of women. Therefore, it is important to better understand the factors associated with the development of persistent pain.

Several theories have been proposed regarding the development of CPMP, including increased peripheral nociceptor sensitivity (primary hyperalgesia) at the site of injury, central neuronal sensitivity (central hyperalgesia) in spinal and supraspinal regions innervating the injured area, and inflammatory changes triggered by the central nervous system. Recommended methods to prevent CPMP include careful dissection, reduction of inflammatory responses, and the use of minimally invasive surgical techniques to prevent peripheral and central neuronal sensitization.

Epidemiological studies-both retrospective and prospective-have identified some of these risk factors, such as younger age, chemotherapy, radiotherapy, and the presence of preoperative pain or severe acute postoperative pain. Unfortunately, there are few studies on this topic, and the literature needs further support.

The hypothesis in this study is that if investigator can identify the factors that increase chronic pain after mastectomy, investigator can take measures against these factors and reduce the development of chronic pain. Therefore, this study aims to identify the factors contributing to chronic pain after mastectomy.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 18-80
* BMI 18-35 kg/m2
* ASA (American Society of Anesthesiologists) Scoring I-II-III
* Elective mastectomy surgery
* Elective mastectomy and axillary dissection surgery
* Patients who will undergo general anesthesia
* Patients who agree to participate in the study and sign a form

Exclusion Criteria:

* Patients under 18 and over 80 years of age
* Patients who do not want to participate in the study
* Patients with chronic pain or chronic opioid use
* Patients with alcohol, substance or drug addiction
* Patients with a history of previous mastectomy
* Patients with limited cooperation such as dementia, psychiatric disorders
* Pregnant and breastfeeding patients will be excluded from the study
* Patients who cannot communicate in their native language will be excluded from the study

Primary outcomes:
measure: Self-leeds assessment of neuropathic symptoms and sign findings in 3rd months.
timeFrame: Postoperative 3rd month
Secondary outcomes:
measure: Short Form 12 questionnaire in the 3rd month
timeFrame: Postoperative 3rd month
measure: Short Form 12 questionnaire in the 6th month
timeFrame: Postoperative 6th month
measure: Self-leeds assessment of neuropathic symptoms and sign findings at 6th months
timeFrame: Postoperative 6th month
measure: Acute pain score
timeFrame: Up to 24 hours after the operation
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Etlik City Hospital
state: Yenimahalle
Study officials:
affiliation: Ankara Etlik City Hospital
name: Musa ZENGİN, Associate Professor
role: STUDY_DIRECTOR
References: