MastectomyBAC-UPP 1NCT07271589
Biological and Clinical Underpinnings of Postoperative Pain - Mastectomy
An observational study of Mastectomy, run by University of Alabama at Birmingham.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Mastectomy
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 31 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled to undergo mastectomy
Who may be able to join
- Participants scheduled for breast surgery/mastectomy ; 2) age between 18-65; 3) understanding of verbal and written English.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Biological and Clinical Underpinnings of Postoperative Pain - Mastectomy (BAC-UPP 1 Study)
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:
- 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.
- 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.
- 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.
- 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.
Read the detailed description
The overarching goal of this study is to elucidate the biological, psychological, and clinical factors that are responsible for pain trajectories following mastectomy. Using a biopsychosocial framework, we aim to identify modifiable risk and protective mechanisms that could inform the development of targeted interventions to prevent chronic postsurgical pain.
Aim 1: Characterize individual differences in pain processing using standardized experimental pain testing.
Participants will complete a battery of quantitative sensory testing (QST) measures preoperatively to assess their sensitivity to mechanical, thermal, and pressure-based stimuli. These standardized tests capture individual differences in nociceptive and central pain modulation. By linking preoperative pain sensitivity profiles to postoperative pain intensity and duration, we will determine whether QST-derived measures can serve as early predictors of maladaptive pain trajectories.
Aim 2: Examine biological and inflammatory mechanisms underlying postoperative pain persistence.
Peripheral blood samples will be collected at multiple time points before and after surgery to quantify circulating markers of inflammation (e.g., IL-6, CRP), neuroendocrine function (e.g., oxytocin, vasopressin), and immune regulation. These biomarkers will be analyzed in relation to clinical pain outcomes to identify biological signatures associated with resilience versus vulnerability to chronic pain. This aim will provide mechanistic insight into how systemic physiological responses to surgery contribute to prolonged nociceptive signaling.
Aim 3: Assess psychosocial determinants of pain and recovery.
We will evaluate key psychological and social-contextual variables, including emotional health, coping style, catastrophizing, optimism, perceived stress, and socioeconomic indicators-to determine how these factors influence postoperative pain experiences and recovery. This comprehensive assessment will clarify how psychological resilience and environmental stressors interact with biological processes to shape individual pain outcomes.
Aim 4: Develop a multidimensional risk model integrating demographic, clinical, and mechanistic predictors.
Using routinely collected demographic and perioperative data (e.g., age, sex, race, comorbidities, analgesic use, surgical approach), combined with the experimental, biological, and psychosocial measures from Aims 1-3, we will construct an integrative predictive model of postoperative pain outcomes. This approach will allow us to identify distinct risk phenotypes and generate clinically actionable profiles for early identification of patients most likely to benefit from personalized perioperative pain management strategies.
Together, these efforts will advance our understanding of how biological, psychological, and contextual factors jointly influence pain recovery after surgery, with the long-term goal of informing precision pain medicine and improving postoperative care.
- Conditions
- Mastectomy
- Keywords
- Mastectomy, breast surgery, nociception, acute pain, chronic pain
- Medical subject headings
- Acute Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Breast Surgery/Mastectomy Patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start1 Sep 2026 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for MastectomyStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Demario Overstreet, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07271589
- Sponsor's protocol ID
- IBR-300015322
- Other IDs
- 1R35GM159908-01
- Acronym
- BAC-UPP 1
- Status last verified
- Jul 2026
- First submitted
- 27 Nov 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: de-identified QST data, biomarkers, survey responses, demographics
Publications
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.
PubMed 38323608Gan 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.
PubMed 29026331Horn 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/
PubMed 31335018Dobson 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.
PubMed 32738546Small C, Laycock H. Acute postoperative pain management. Br J Surg. 2020 Jan;107(2):e70-e80. doi: 10.1002/bjs.11477.
PubMed 31903595Katz 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.
PubMed 19402781Bruce J, Quinlan J. Chronic Post Surgical Pain. Rev Pain. 2011 Sep;5(3):23-9. doi: 10.1177/204946371100500306.
PubMed 26526062
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological and Clinical Underpinnings of Postoperative Pain - Mastectomy (BAC-UPP 1 Study)
- ClinicalTrials.gov ID
- NCT07271589
- Acronym / sponsor ID
- BAC-UPP 1 / IBR-300015322
- Conditions
- Mastectomy
- Keywords
- Mastectomy, breast surgery, nociception, acute pain, chronic pain
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
- 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.
Detailed description
The overarching goal of this study is to elucidate the biological, psychological, and clinical factors that are responsible for pain trajectories following mastectomy. Using a biopsychosocial framework, we aim to identify modifiable risk and protective mechanisms that could inform the development of targeted interventions to prevent chronic postsurgical pain.
Aim 1: Characterize individual differences in pain processing using standardized experimental pain testing.
Participants will complete a battery of quantitative sensory testing (QST) measures preoperatively to assess their sensitivity to mechanical, thermal, and pressure-based stimuli. These standardized tests capture individual differences in nociceptive and central pain modulation. By linking preoperative pain sensitivity profiles to postoperative pain intensity and duration, we will determine whether QST-derived measures can serve as early predictors of maladaptive pain trajectories.
Aim 2: Examine biological and inflammatory mechanisms underlying postoperative pain persistence.
Peripheral blood samples will be collected at multiple time points before and after surgery to quantify circulating markers of inflammation (e.g., IL-6, CRP), neuroendocrine function (e.g., oxytocin, vasopressin), and immune regulation. These biomarkers will be analyzed in relation to clinical pain outcomes to identify biological signatures associated with resilience versus vulnerability to chronic pain. This aim will provide mechanistic insight into how systemic physiological responses to surgery contribute to prolonged nociceptive signaling.
Aim 3: Assess psychosocial determinants of pain and recovery.
We will evaluate key psychological and social-contextual variables, including emotional health, coping style, catastrophizing, optimism, perceived stress, and socioeconomic indicators-to determine how these factors influence postoperative pain experiences and recovery. This comprehensive assessment will clarify how psychological resilience and environmental stressors interact with biological processes to shape individual pain outcomes.
Aim 4: Develop a multidimensional risk model integrating demographic, clinical, and mechanistic predictors.
Using routinely collected demographic and perioperative data (e.g., age, sex, race, comorbidities, analgesic use, surgical approach), combined with the experimental, biological, and psychosocial measures from Aims 1-3, we will construct an integrative predictive model of postoperative pain outcomes. This approach will allow us to identify distinct risk phenotypes and generate clinically actionable profiles for early identification of patients most likely to benefit from personalized perioperative pain management strategies.
Together, these efforts will advance our understanding of how biological, psychological, and contextual factors jointly influence pain recovery after surgery, with the long-term goal of informing precision pain medicine and improving postoperative care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast Surgery/Mastectomy Patients | – | – |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled to undergo mastectomy
Key inclusion criteria (1 listed)
- Participants scheduled for breast surgery/mastectomy ; 2) age between 18-65; 3) understanding of verbal and written English.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Chronic Pain after Mastectomy (Using Brief Pain Inventory - Short Form)
Time frame: 12 weeks after surgery
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.
Acute Pain after Surgery (using Brief Pain Inventory- Short Form)
Time frame: 48 hours after surgery
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Background: PubMed 38323608Overstreet 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.
- Background: PubMed 29026331Gan 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.
- Background: PubMed 31335018Horn 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/
- Background: PubMed 32738546Dobson 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.
- Background: PubMed 31903595Small C, Laycock H. Acute postoperative pain management. Br J Surg. 2020 Jan;107(2):e70-e80. doi: 10.1002/bjs.11477.
- Background: PubMed 19402781Katz 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.
- Background: PubMed 26526062Bruce J, Quinlan J. Chronic Post Surgical Pain. Rev Pain. 2011 Sep;5(3):23-9. doi: 10.1177/204946371100500306.
- Individual participant dataSharing planned: Yes. de-identified QST data, biomarkers, survey responses, demographics
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Mastectomy, run by University of Alabama at Birmingham.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Demario S. Overstreet, Ph.D. (3344130112, demariooverstreet@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic Pain after Mastectomy (Using Brief Pain Inventory - Short Form) (time frame: 12 weeks after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07271589, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.