Affecting Factors for Chronic Pain After Mastectomy

NCT ID: NCT06592053

Last Updated: 2025-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-25

Study Completion Date

2026-10-30

Brief Summary

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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

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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.

Conditions

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Mastectomy Pain, Chronic Pain, Acute Breast Surgery Breast Cancer Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Breast Cancer Surgery Pain

Factors affecting the occurrence of chronic pain in patients undergoing elective mastectomy surgery will be investigated.

Intervention Type PROCEDURE

Other Intervention Names

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Breast Cancer Surgery Chronic Pain

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ankara Etlik City Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Berkant Demiray

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Musa ZENGİN, Associate Professor

Role: STUDY_DIRECTOR

Ankara Etlik City Hospital

Locations

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Ankara Etlik City Hospital

Ankara, Yenimahalle, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Berkant DEMİRAY, M.D.

Role: CONTACT

+905333375556

Musa ZENGİN, Associate Professor

Role: CONTACT

+905307716235

Facility Contacts

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Berkant DEMİRAY, M.D.

Role: primary

+905307716235

Musa ZENGİN, Associate Professor

Role: backup

+905307716235

Other Identifiers

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AEŞH-BADEK-2024-414

Identifier Type: -

Identifier Source: org_study_id

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