Biological and Clinical Underpinnings of Postoperative Pain - Mastectomy

Persistent pain after mastectomy remains a significant clinical challenge that can delay recovery, reduce quality of life, and increase long-term healthcare burden. The goal of this study is to gain a deeper understanding of the biological and clinical factors that influence pain severity after mastectomy and contribute to the transition from acute to chronic postoperative pain. Guided by a biopsychosocial framework, this research will address the following aims: 1. We will use standardized experimental pain testing before surgery to evaluate how patients respond to different types of controlled sensory stimuli. These responses may help predict who is more likely to experience severe or prolonged pain after surgery. 2. We will analyze blood samples collected before and after surgery to measure markers of inflammation and other biological responses. These data will help us explore how the body's immune and hormonal systems relate to pain severity in both the short- and longer-term recovery phases. 3. We will assess psychological and clinical factors, such as emotional health, coping style, household income, and life stressors, to understand how they contribute to patients' pain experiences throughout recovery. 4. We will examine whether routinely collected demographic and clinical characteristics can help identify patients at greater risk of experiencing higher levels of pain after surgery. This approach will allow us to better understand which patients may benefit from more tailored perioperative pain management strategies.

NCT Number	NCT07271589
Lead Sponsor	University of Alabama at Birmingham Collaborators: National Institute of General Medical Sciences (NIGMS)
Conditions	Mastectomy
Enrollment	86 participants
Start Date	2026-09-01
Primary Completion	2028-08-31 (estimated)
Study Completion	2028-08-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-13