Biological and Clinical Underpinnings of Postoperative Pain - Mastectomy

NCT07271589 | Not Yet Recruiting DMC

• 2 other identifiers: IBR-3000153221R35GM159908-01
• Study Type: observational
• Target: 86
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. 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. 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. 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. 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.

Conditions

Mastectomy

Keywords

Mastectomy; breast surgery; nociception; acute pain; chronic pain

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  48 hours after surgery

Study Arms (1)

Breast Surgery/Mastectomy Patients

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled to undergo mastectomy

You may qualify if:

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

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Related Publications (7)

• Overstreet DS, Strath LJ, Sorge RE, Thomas PA, He J, Wiggins AM, Hobson J, Long DL, Meints SM, Aroke EN, Goodin BR. Race-specific associations: inflammatory mediators and chronic low back pain. Pain. 2024 Jul 1;165(7):1513-1522. doi: 10.1097/j.pain.0000000000003154. Epub 2024 Feb 6.

  PMID: 38323608 BACKGROUND

• Gan TJ. Poorly controlled postoperative pain: prevalence, consequences, and prevention. J Pain Res. 2017 Sep 25;10:2287-2298. doi: 10.2147/JPR.S144066. eCollection 2017.

  PMID: 29026331 BACKGROUND

• Horn R, Hendrix JM, Kramer J. Postoperative Pain Control. 2024 Jan 30. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK544298/

  PMID: 31335018 BACKGROUND

• Dobson GP. Trauma of major surgery: A global problem that is not going away. Int J Surg. 2020 Sep;81:47-54. doi: 10.1016/j.ijsu.2020.07.017. Epub 2020 Jul 29.

  PMID: 32738546 BACKGROUND

• Small C, Laycock H. Acute postoperative pain management. Br J Surg. 2020 Jan;107(2):e70-e80. doi: 10.1002/bjs.11477.

  PMID: 31903595 BACKGROUND

• Katz J, Seltzer Z. Transition from acute to chronic postsurgical pain: risk factors and protective factors. Expert Rev Neurother. 2009 May;9(5):723-44. doi: 10.1586/ern.09.20.

  PMID: 19402781 BACKGROUND

• Bruce J, Quinlan J. Chronic Post Surgical Pain. Rev Pain. 2011 Sep;5(3):23-9. doi: 10.1177/204946371100500306.

  PMID: 26526062 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood Specimen Collection: The following biomarkers: (proinflammatory) Fibrinogen, Serum Amyloid A, interleukin-1 alpha (IL-1α), 1IL-1β, IL-6, Tumor necrosis factor-alpha (TNF-α), and (Anti-inflammatory) Vitamin D, IL4, IL10, IFN-a will be determined by implementing the Meso Scale Discovery, which is an enzyme-linked immunosorbent assay (ELISA) that employs electrochemiluminescence to identify specific binding events.

MeSH Terms

Conditions

Acute Pain; Chronic Pain

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Demario S. Overstreet, Ph.D.

CONTACT

3344130112; demariooverstreet@uabmc.edu

Tammie Quinn, BA

CONTACT

205-934-8743; tquinn@uab.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 9, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Available 6 months after publication of primary results
• Access Criteria: This data/information will be made available via email request