Trial · NCT07885085
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| 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. |
| Secondary | Past 24-Hour Average Pain Intensity | Baseline, 2 weeks, 1 month, 3 months, and 6 months after surgery. | Participants will rate the average 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 | PROMIS Pain Interference T-Score | Baseline, 2 weeks, 1 month, 3 months, and 6 months after surgery. | The effect of pain on daily activities, social participation, emotional functioning, and physical functioning will be assessed using the PROMIS Pain Interference Short Form 8a. Raw scores will be converted to standardized PROMIS T-scores. Results will be reported as mean T-scores, standard deviations, and mean changes from baseline. Higher T-scores indicate greater pain-related interference. |
| Secondary | Short-Form McGill Pain Questionnaire-2 Total Score | Baseline, 2 weeks, 1 month, 3 months, and 6 months after surgery. | Pain quality will be measured using the Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2). The outcome measure will be the total questionnaire score derived according to instrument scoring procedures. Results will be reported as mean total scores, standard deviations, and mean changes from baseline. Higher scores indicate greater pain symptom burden. |
| Secondary | Pain Assessment in Impaired Cognition (PAIC) Total Score | Baseline, 2 weeks, 1 month, 3 months, and 6 months after surgery. | Pain-related behaviors will be assessed using the Pain Assessment in Impaired Cognition (PAIC) instrument. Total scores will be calculated according to published scoring procedures. Results will be reported as mean PAIC scores and mean changes from baseline. Higher scores indicate greater observed pain-related behaviors. |
| Secondary | Michigan Body Map Pain Site Count | Baseline and 6 months after surgery. | The number of body regions affected by persistent or recurrent pain will be identified using the Michigan Body Map. The outcome measure will be the total count of painful body sites. Results will be reported as mean number of painful body regions and mean changes from baseline. Higher values indicate more widespread pain. |
| Secondary | Opioid Side Effect Severity Score | 2 weeks, 1 month, 3 months, and 6 months after surgery. | Participant-reported opioid-related adverse effects will be assessed using visual analog scales measuring symptom severity. The outcome measure will be the severity score for each side effect and a composite side-effect burden score derived from all reported symptoms. Results will be reported as mean scores and changes over time. Higher scores indicate greater side-effect burden. |
| Secondary | Participants Experiencing Unplanned Healthcare Utilization | From surgery through 6 months postoperatively. | Healthcare utilization will be assessed through medical record review. The outcome measure will be the number and percentage of participants experiencing at least one postoperative emergency department visit, hospital readmission, urgent care visit, or unplanned provider visit related to surgical recovery. Results will be reported as participant counts and percentages for each study group. |
| Secondary | Caregiver-Reported Opioid Management Difficulties | 2 weeks, 1 month, 3 months, and 6 months after surgery. | Number and percentage of caregivers reporting missed doses, extra doses, medication administration concerns, or medication management difficulties during postoperative follow-up. |
| Other | Difference in Pain Outcomes by APOE4 Carrier Status | Baseline through 6 months after surgery. | Participants will be categorized as APOE4 carriers or non-carriers. Outcomes including pain intensity, opioid utilization, heat pain threshold, temporal summation, and vagal inhibitory function will be compared between groups. Results will be reported as mean values, mean differences, and estimated effect sizes. |
| Other | Difference in Pain Outcomes by Plasma Amyloid Beta 42/40 Ratio | Baseline through 6 months after surgery. | Participants will be categorized according to plasma amyloid beta 42/40 ratio status. Postoperative pain, opioid use, quantitative sensory testing measures, and heart rate variability outcomes will be compared between biomarker-defined groups. Results will be reported as mean outcome values, group differences, and estimated effect sizes. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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