NCT07885085 · NOT YET RECRUITING
Postsurgical Pain and Opioid Use in Older Adults: Effects of Mild Cognitive Impairment
This is an observational study, so nothing is being tested as a treatment. Researchers will follow older adults with and without mild cognitive impairment (MCI) through major orthopedic or spine surgery. They will track pain, opioid use, and thinking for six months afterward. No phase applies because no drug or therapy is given.
Eligibility criteria
Inclusion Criteria: 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 Exclusion Criteria: PATIENT PARTICIPANTS: * Emergency or urgent surgeries * Reoperation after prior total hip, knee, or complex spine surgery * 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: * Unable or unwilling to provide written consent * 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 * 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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-10-21