Biological and Clinical Underpinnings of Postoperative Pain - Mastectomy

ConditionMastectomy

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-89

SponsorUniversity of Alabama at Birmingham

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants scheduled for breast surgery/mastectomy ; 2) age between 18-65; 3) understanding of verbal and written English.

Disqualifiers

1) concurrent medical conditions that could confound the interpretation of the data; 2) HIV positive diagnosis; 3) cardiovascular or pulmonary disease; 4) systemic rheumatoid disease; 5) uncontrolled hypertension (i.e. SBP/DBP of > 150/95); 6) current illness accompanied by fever (body temperature >38 °C); 7) any other chronic pain condition; 8) conditions resulting in altered nerve sensation; 9) hospitalization due to psychiatric illness within the last 6 months; 10) poorly controlled diabetes; 11) history of stroke; 12) history of seizures; 13) circulatory disorders such AS Raynauds' disease 14) history of drug or alcohol abuse.

Trial population

Patients scheduled to undergo mastectomy

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

86 Participants

are grouped into 1 trial group

Group A: Breast Surgery/Mastectomy Patients

Trial outcomes

Primary outcomes

Chronic Pain after Mastectomy (Using Brief Pain Inventory - Short Form)

Pain measured 3 months following mastectomy The BPI-SF is a multidimensional pain scale used to assess self-reported pain severity and its interference with daily functioning. The questionnaire is composed of four items asking about pain severity (worst pain, least pain, average pain, and pain right now) over the past 24 h. Additionally, seven items assess the degree to which pain interferes with functioning in the following domains: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Each item is scored from 0 (no pain or does not interfere) to 10 (worst imaginable pain or completely interferes). Higher scores suggest greater pain severity and pain interference. The BPI-SF is a well validated chronic pain questionnaire that has previously been used in samples with cLBP.

Time frame

12 weeks after surgery

Acute Pain after Surgery (using Brief Pain Inventory- Short Form)

Pain rating 48 hours after surgery using Brief Pain Questionnaire The BPI-SF is a multidimensional pain scale used to assess self-reported pain severity and its interference with daily functioning. The questionnaire is composed of four items asking about pain severity (worst pain, least pain, average pain, and pain right now) over the past 24 h. Additionally, seven items assess the degree to which pain interferes with functioning in the following domains: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Each item is scored from 0 (no pain or does not interfere) to 10 (worst imaginable pain or completely interferes). Higher scores suggest greater pain severity and pain interference. The BPI-SF is a well validated chronic pain questionnaire that has previously been used in samples with cLBP.

Time frame

48 hours after surgery

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama at Birmingham

Lead sponsor

National Institute of General Medical Sciences (NIGMS)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: