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Affecting Factors for Chronic Pain After Mastectomy

Affecting Factors for the Incidence of Chronic Pain After Mastectomy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06592053
Acronym
CPMP
Enrollment
200
Registered
2024-09-19
Start date
2024-09-25
Completion date
2026-04-01
Last updated
2026-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

PROCEDUREBreast Cancer Surgery Pain

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

Sponsors

Ankara Etlik City Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Self-leeds assessment of neuropathic symptoms and sign findings in 3rd months.Postoperative 3rd monthPatients; self-Leeds assessment of neuropathic symptoms and sign (S-LANSS) findings will be evaluated in the 3rd postoperative month. Patients with an S-LANSS score of 12 and above will be diagnosed with chronic neuropathic pain. In this scoring, the patient can get at least 0 points. He can get a maximum of 24 points. If the patient's score is 12 or above, the possibility of neuropathic pain is considered high.

Secondary

MeasureTime frameDescription
Short Form 12 questionnaire in the 3rd monthPostoperative 3rd monthShort Form 12 questionnaire will be evaluated in the 3rd month to evaluate the quality of life of the patients.
Short Form 12 questionnaire in the 6th monthPostoperative 6th monthShort Form 12 questionnaire will be evaluated in the 6th month to evaluate the quality of life of the patients
Self-leeds assessment of neuropathic symptoms and sign findings at 6th monthsPostoperative 6th monthPatients; self-Leeds assessment of neuropathic symptoms and sign (S-LANSS) findings will be evaluated in the 3rd postoperative month. Patients with an S-LANSS score of 12 and above will be diagnosed with chronic neuropathic pain. In this scoring, the patient can get at least 0 points. He can get a maximum of 24 points. If the patient's score is 12 or above, the possibility of neuropathic pain is considered high.
Acute pain scoreUp to 24 hours after the operationPain 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 made at 0, 1, 24th hours in the postoperative period.

Countries

Turkey (Türkiye)

Contacts

STUDY_DIRECTORMusa ZENGİN, Associate Professor

Ankara Etlik City Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 5, 2026