An observational study in Pain, Postoperative, Atrial Fibrillation and Cognitive Dysfunction, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-21.
Sponsored by Duke University · Observational
The purpose of this study is to determine whether baroreceptor sensitivity (the ability of your body to change your heart rate and/or blood pressure in response to a situation) has any effect on how likely you are to suffer certain events after heart or lung surgery. The postoperative events that the investigators will be studying are pain after surgery, atrial fibrillation (an irregular heart rhythm), and cognitive dysfunction (a decline in mental abilities).
The purpose of this study is to determine if preoperative baroreceptor sensitivity (BRS) correlates with major outcomes after cardiac and thoracic surgery, including acute and chronic pain, atrial arrhythmias, and cognitive function. To test this hypothesis, approximately 95 patients will be enrolled, and spontaneous baroreceptor sensitivity will be measured prior to surgery as well as immediately postoperatively. Outcomes will include acute pain using the numeric rating scale, Brief Pain Inventory, and Gracely Box Scale administered preoperatively, on postoperative days 1 and 2 and by phone at 6-weeks postoperatively. Chronic pain will be assessed at 6-month follow-up visit via hyperalgesia testing using Von Frey filaments. Postoperative atrial arrhythmias will be assessed by review of postoperative telemetry, the electronic medical record, and ECG performed prior to discharge. Finally, cognitive function will be assess via Mini-Mental State examination administered preoperative and at the 6-month follow-up visit. Association between BRS and the outcomes of interest will be tested with regression models adjusted for appropriate covariates. Significance threshold alpha will be adjusted for the number of statistical tests using the Bonferroni correction. Our hypothesis is that patients with impaired preoperative BRS will have an increased incidence of acute and chronic postoperative pain, atrial fibrillation, and cognitive decline after surgery.
5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.
This study's enrollment of 72 is below the median of 100 across 622 observational studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Duke University is the lead sponsor of 2,058 studies on the registry; 274 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 165 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
All patients presenting for cardiac and thoracic surgery at Duke University Hospital, a quaternary referral center
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
No interventions. Patients undergoing cardiothoracic surgery will be assessed for baroreflex sensitivity and the outcomes of interest.
Baseline baroreflex sensitivity
Non-invasive BRS testing with BIOPAC MP160
Time frame: 30 min
Postoperative day (POD) 1 baroreflex sensitivity
Non-invasive BRS testing with BIOPAC MP160
Time frame: 30 min
POD 2 baroreflex sensitivity
Non-invasive BRS testing with BIOPAC MP160
Time frame: 30 min
6 month baroreflex sensitivity
Non-invasive BRS testing with BIOPAC MP160
Time frame: 6 months
Acute postoperative pain as assessed by the numeric rating scale (NRS) - 24h
Median NRS pain score in the first 24h after surgery
Time frame: 24 hours
Acute postoperative pain as assessed by the numeric rating scale (NRS) - 48h
Median NRS pain score in the second 24h after surgery
Time frame: 48 hours
Acute postoperative pain as assessed by the Gracely Box Scale (GBS) - POD1
GBS survey on POD 1
Time frame: 15 min
Acute postoperative pain as assessed by the Gracely Box Scale (GBS) - POD2
GBS survey on POD 2
Time frame: 15 min
Acute postoperative pain as assessed by the Gracely Box Scale (GBS) - 6 mo
GBS survey at 6 month follow-up visit
Time frame: 6 months
Chronic pain as assessed by the change in Brief Pain Inventory score
Change from baseline to 6 months postoperatively
Time frame: Baseline, 6 months
Hyperalgesia
Nociceptive threshold as assessed by Von Frey filament testing at 6 month follow-up
Time frame: 6 months
Area of hyperalgesia or allodynia
Area surrounding operative incision as assessed by Von Frey filament testing at 6 month follow-up
Time frame: 6 months
Postoperative atrial fibrillation
Chart review assessment of the occurrence of postoperative atrial fibrillation during hospitalization and up to 6 weeks postoperatively
Time frame: 6 weeks
Postoperative cognitive change
Change from baseline to 6 months in the Mini Mental Status Exam score
Time frame: Baseline, 6 months
Baseline psychological distress
As assessed by the Brief Symptom Inventory-18
Time frame: 15 min
6 month psychological distress
As assessed by the Brief Symptom Inventory-18
Time frame: 6 months
Baseline frailty
As assessed by the Modified Frailty Index
Time frame: 10 min
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Sep 2017 to primary completion in Dec 2021, 51 months.
Of 347 non-industry observational studies under Pain, Postoperative, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 31. This study's 51 months is above that.
Counting every sponsor, half of 352 studies reached it within 14 months; a quarter within 6 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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