NCT07885085Not yet recruiting
Postsurgical Pain and Opioid Use in Older Adults: Effects of Mild Cognitive Impairment
Source: ClinicalTrials.gov · Last updated 21 Oct 2026
Brief summary (registry, in English)
Mild cognitive impairment (MCI) affects a substantial proportion of older adults undergoing major surgery and may alter pain processing, pain experience, and opioid use after surgery. This prospective observational cohort study will compare older adults with MCI and cognitively intact older adults undergoing major orthopedic and complex spine procedures. Participants will undergo preoperative assessment of cognitive function, quantitative sensory testing, heart rate variability, clinical pain, and biomarkers associated with Alzheimer's disease risk. Postoperative pain trajectories, opioid use, pain responsiveness, and cognitive outcomes will be evaluated for six months following surgery. The study aims to determine whether MCI is associated with differences in postoperative pain and opioid use outcomes and whether APOE4 status and plasma amyloid beta 42/40 ratio contribute to observed differences.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 552 (estimated)
- First submitted
- 13 Oct 2026
- Start date
- Jan 2027
- Primary completion date
- Jan 2031
- Lead sponsor
- Miklos Kertai
- NCT number
- NCT07885085
What you commit to
- Study type: Observational
- Planned participants: 552
- From Jan 2027 to the primary completion date, Jan 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Reoperation after prior total hip, knee, or complex spine surgery
Other illness
- Current or past dementia diagnosis
- History of cerebrovascular disease or stroke
- Diagnosis of postoperative or post-intensive care neurocognitive disorder within the 12 months
- CAREGIVER PARTICIPANTS:
- Evidence of impaired decisional capacity (e.g., known dementia, acute intoxication, or acute medical or psychiatric condition)-disqualifying particularly for a caregiver serving as surrogate/LAR
Other
- PATIENT PARTICIPANTS:
- Emergency or urgent surgeries
- Unable or unwilling to provide written consent
- Sensory, motor, cognitive, or language limitation precluding reliable self-completion of questionnaires
- Paid/professional caregiver serving in a formal capacity (e.g., hired aide or private-duty nurse), as the study targets informal caregiving
- Declines participation
Who the study is looking for
- PATIENT PARTICIPANTS:
- Aged 65 years or older
- Ability to provide informed consent
- English literacy sufficient to complete study measures
- No daily opioid use in the prior 3 months
- Residence within a 1-hour drive of Nashville
- Deemed healthy enough for quantitative sensory testing (QST) procedures by surgical Co-Investigators
- Undergoing elective surgical procedures including tier 2 or 3 procedures (e.g., posterior cervical fusion, thoracic/lumbar fusion \>= 3 levels)
- CAREGIVER PARTICIPANTS:
- Age \>= 18 years at the time of consent
- Identified as the patient's spouse/partner, adult family member, or other unpaid informal caregiver-and, for a patient scoring \<= 14.5 on the University of California San Diego Brief Assessment of Capacity to Consent (UBACC), the designated surrogate/legally authorized representative (LAR) under the applicable institutional and state hierarchy
- In regular contact with the patient (in person, by phone, or by video) across the 6-month follow-up period, sufficient to observe the patient's home opioid use
- Able to read and respond to study materials in English
- Able and willing to provide written consent-for their own participation and/or on the patient's behalf as surrogate/LAR
- Passes the pre-consent caregiver cognitive/capacity screen
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vanderbilt Health Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.