Trial · NCT07885085
Postsurgical Pain and Opioid Use in Older Adults: Effects of Mild Cognitive Impairment
NCT07885085, Not yet recruiting, Miklos Kertai
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Postsurgical Pain and Opioid Use in Older Adults: Effects of Mild Cognitive Impairment. Trials, record NCT07885085. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07885085
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Postsurgical Pain and Opioid Use in Older Adults: Effects of Mild Cognitive Impairment
- NCT number
- NCT07885085
- Status
- Not yet recruiting
- Enrollment
- 552 participants, estimated
- Lead sponsor
- Miklos Kertai
- Conditions
- Mild Cognitive Impairment (MCI), Opioid Use, Cognitive Dysfunction, Postoperative Pain
- First posted
- 2026-10-21
- Last updated
- 2026-10-21
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Past 24-Hour Average Pain Intensity | Baseline, 2 weeks, 1 month, 3 months, and 6 months after surgery. | Average postoperative pain intensity will be measured using an 11-point Numeric Rating Scale (NRS) ranging from 0 (No Pain) to 10 (Worst Possible Pain). Participants will rate their average pain during the previous 24 hours at each assessment. Results will be reported as the mean NRS score and standard deviation for each study group at each time point, as well as the mean change from baseline. Between-group differences in pain trajectories across the postoperative period will be assessed. |
| Primary | Cumulative Postoperative Opioid Use | Postoperative Discharge through 6 months after surgery. | Postoperative opioid use will be quantified through pill counts and electronic health record review. All opioid medications consumed will be converted to morphine milligram equivalents (MME). Results will be reported as the cumulative MME consumed during each follow-up interval and cumulatively through 6 months after surgery. Mean MME, standard deviation, median, and range will be reported for each study group. |
| Primary | Heat Pain Threshold Temperature | Baseline, 2 weeks, 1 month, 3 months, and 6 months after surgery. | Heat pain threshold will be assessed using the Medoc TSA2 Air quantitative sensory testing system. The outcome measure is the average temperature in degrees Celsius at which thermal stimulation is first perceived as painful across four testing trials. Results will be reported as mean threshold temperature (°C), standard deviation, and mean change from baseline. Lower temperatures indicate increased pain sensitivity. |
| Primary | High-Frequency Heart Rate Variability (HF-HRV) | Baseline, 2 weeks, 1 month, 3 months, and 6 months after surgery. | Cardiac vagal regulation will be assessed from a 5-minute resting electrocardiographic recording. The primary outcome will be high-frequency heart rate variability derived using Kubios HRV software according to established HRV analysis methods. Results will be reported as mean HF-HRV values and mean change from baseline for each study group. Higher values indicate greater vagal inhibitory control. |
| Secondary | Temporal Summation of Pain | Baseline, 2 weeks, 1 month, 3 months, and 6 months after surgery. | Temporal summation will be assessed using repeated standardized pinprick stimulation. The outcome measure will be calculated as the difference between the pain intensity rating following a single stimulus and the maximum pain intensity rating reported during a train of ten repeated stimuli. Results will be reported as mean temporal summation scores and changes from baseline. Higher positive values indicate greater central sensitization. |
| Secondary | Suprathreshold Heat Pain Intensity Rating | Baseline, 2 weeks, 1 month, 3 months, and 6 months after surgery. | Participants will rate the intensity of four suprathreshold heat stimuli using an 11-point Numeric Rating Scale ranging from 0 (No Pain) to 10 (Worst Possible Pain). The outcome measure will be the mean pain intensity rating across all suprathreshold stimuli. Results will be reported as mean ratings, standard deviations, and mean change from baseline. |
| Secondary | Suprathreshold Heat Pain Unpleasantness Rating | Baseline, 2 weeks, 1 month, 3 months, and 6 months after surgery. | Participants will rate the unpleasantness associated with suprathreshold thermal stimuli using an 11-point Numeric Rating Scale ranging from 0 (Not Unpleasant at All) to 10 (Most Unpleasant Possible). The outcome measure will be the average unpleasantness score across all test stimuli. Results will be reported as mean scores and mean changes from baseline. Higher scores indicate greater affective pain response. |
| Secondary | Past 24-Hour Pain Unpleasantness | Baseline, 2 weeks, 1 month, 3 months, and 6 months after surgery. | Participants will rate the overall unpleasantness of pain experienced during the previous 24 hours using an 11-point Numeric Rating Scale ranging from 0 (Not Unpleasant at All) to 10 (Most Unpleasant Possible). Results will be reported as mean unpleasantness scores and change from baseline values for each study group. |
| Secondary | Past 24-Hour Worst Pain Intensity | Baseline, 2 weeks, 1 month, 3 months, and 6 months after surgery. | Participants will rate the worst pain intensity experienced during the previous 24 hours using an 11-point Numeric Rating Scale ranging from 0 (No pain at All) to 10 (Most Intense Pain Possible). Results will be reported as mean worst pain scores and change from baseline values for each study group. |
| Secondary | Past 24-Hour Least Pain Intensity | Baseline, 2 weeks, 1 month, 3 months, and 6 months after surgery. | Participants will rate the least pain intensity experienced during the previous 24 hours using an 11-point Numeric Rating Scale ranging from 0 (No pain at All) to 10 (Most Intense Pain Possible). Results will be reported as mean worst pain scores and change from baseline values for each study group. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01AG098934 | Postsurgical Pain and Opioid Use in Older Adults: Effects of Mild Cognitive Impairment | Kertai, Miklos David; Bruehl, Stephen | VANDERBILT UNIVERSITY MEDICAL CENTER | NATIONAL INSTITUTE ON AGING | 2026 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Verbal Learning | Other outcome |
Source ConductCognition
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07885085
GET https://conductscience.org/api/trials/v1/NCT07885085/registered?page=2