Affecting Factors for Chronic Pain After Mastectomy

Last updated: January 31, 2025
Sponsor: Ankara Etlik City Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pain

Chronic Pain

Mastectomy

Treatment

Breast Cancer Surgery Pain

Clinical Study ID

NCT06592053
AEŞH-BADEK-2024-414
  • Ages 18-80
  • Female

Study 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.

Eligibility Criteria

Inclusion

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

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 thestudy

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Breast Cancer Surgery Pain
Phase:
Study Start date:
September 25, 2024
Estimated Completion Date:
October 30, 2026

Study 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.

Connect with a study center

  • Ankara Etlik City Hospital

    Ankara, Yenimahalle 06100
    Turkey

    Active - Recruiting

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