Affecting Factors for Chronic Pain After Mastectomy

NCT06592053 | Recruiting

• 1 other identifier: AEŞH-BADEK-2024-414
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Self-leeds assessment of neuropathic symptoms and sign findings in 3rd months.

  Patients; 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.

  Postoperative 3rd month

Secondary Outcomes (4)

• Short Form 12 questionnaire in the 3rd month

  Postoperative 3rd month

• Short Form 12 questionnaire in the 6th month

  Postoperative 6th month

• Self-leeds assessment of neuropathic symptoms and sign findings at 6th months

  Postoperative 6th month

• Acute pain score

  Up to 24 hours after the operation

Interventions

Breast Cancer Surgery Pain PROCEDURE

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

Also known as: Breast Cancer Surgery Chronic Pain

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Yenimahalle, 06100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Musa ZENGİN, Associate Professor

  Ankara Etlik City Hospital

  STUDY DIRECTOR

Central Study Contacts

Berkant DEMİRAY, M.D.

CONTACT

+905333375556; berkant.dem@gmail.com

Musa ZENGİN, Associate Professor

CONTACT

+905307716235; musazengin@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 19, 2024
• Study Start: September 25, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: February 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)