Biological and Clinical Underpinnings of Postoperative Pain - Colorectal Surgery

NCT07219160 | Not Yet Recruiting DMC

• 2 other identifiers: IRB-3000152051R35GM159908-01
• Study Type: observational
• Target: 128
• Locations: 0 countries
• Sites: N/A

Brief Summary

Persistent pain after colorectal surgery 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 colorectal surgery 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.The investigators 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.The investigators 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.The investigators 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.The investigators 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

Colorectal Surgery

Keywords

colorectal surgery; nociception; acute pain; chronic pain

Outcome Measures

Primary Outcomes (2)

• Chronic Pain after colorectal surgery

  Pain Measured 3 months following colorectal surgery using the Brief Pain Inventory (BPI) pain score is a 0-40 score with higher scores reflecting more pain. Questions 3-6 are scored on 0-10 and are summed to provide an overall pain score. Change scores will be calculated.

  12 weeks after surgery

• Acute Pain after Surgery

  Pain rating 48 hours after surgery using the Brief Pain Inventory (BPI) pain score is a 0-40 score with higher scores reflecting more pain. Questions 3-6 are scored on 0-10 and are summed to provide an overall pain score. Change scores will be calculated.

  48 hours after surgery

Study Arms (1)

Colorectal Surgery Patients

Patients undergoing colorectal surgery

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 colorectal surgery

You may qualify if:

• Participants scheduled for colorectal cancer surgery
• Age between 18-65; 3)
• Understanding verbal and written English

You may not qualify if:

• Concurrent medical conditions that could confound the interpretation of the data
• Human immunodeficiency virus positive diagnosis
• Cardiovascular or pulmonary disease
• Systemic rheumatoid disease
• Uncontrolled hypertension (i.e. SBP/DBP of \> 150/95
• Current illness accompanied by fever (body temperature \>38 °C)
• Any other chronic pain conditions
• Conditions resulting in altered nerve sensation
• Hospitalization due to psychiatric illness within the last 6 months
• Poorly controlled diabetes
• History of stroke
• History of seizures
• Circulatory disorders such AS Raynauds' disease
• History of drug or alcohol abuse.

Sponsors & Collaborators

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

Related Publications (8)

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

  PMID: 26526062 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

• 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

• 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

• 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

• 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

• Overstreet DS, Hollis RH. Achieving Health Equity: Advancing Colorectal Surgery among Racial and Ethnic Minorities in America. Clin Colon Rectal Surg. 2024 May 13;38(1):34-40. doi: 10.1055/s-0044-1786532. eCollection 2025 Jan.

  PMID: 39734714 BACKGROUND

• 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

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

13344130112; demariooverstreet@uabmc.edu

Tammie Quinn, B.A.

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: October 17, 2025
• First Posted: October 21, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 1, 2030
• Last Updated: March 13, 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