Pain, PostoperativeNCT03243279
BRS and Outcomes in Cardiothoracic Surgery
An observational study of Pain, Postoperative and Atrial Fibrillation, run by Duke University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Atrial Fibrillation, Cognitive Dysfunction
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2017to 31 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients presenting for cardiac and thoracic surgery at Duke University Hospital, a quaternary referral center
Who may be able to join
- >= 18 years of age
- Undergoing cardiac (coronary artery bypass grafting [CABG], CABG + valve, or valve only) or thoracic (video-assisted thoracoscopic [VATS] approach to lobectomy) surgery
Who cannot join
- Any preexisting pain condition (defined as pain of >=3 months duration prior to enrollment)
- Pain at the time of enrollment interview
- Need for preoperative analgesics
- Preexisting chronic or paroxysmal atrial fibrillation
- Preexisting atrial or ventricular arrhythmia
- Need for preoperative anti-arrhythmic medication
Show all 16Show fewer
- History of symptomatic cerebrovascular disease (e.g., prior stroke) with residual deficits
- Alcoholism (>2 drinks/day)
- Psychiatric illness (any clinical diagnosis requiring therapy)
- Drug abuse (any illicit drug use in the preceding 3 months before surgery)
- Hepatic insufficiency (liver function tests > 1.5 times the upper limit of normal)
- Severe pulmonary insufficiency (home oxygen)
- Renal failure (serum creatinine >2.0 mg/dL)
- Non-English speaking
- Unable to read
- Participants who score <24 on baseline Mini Mental State examination
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Role of Preoperative Baroreflex Sensitivity on Major Outcomes After Cardiothoracic Surgery
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).
Read the detailed description
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.
- Medical subject headings
- Pain, Postoperative, Atrial Fibrillation, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Surgical | No interventions. Patients undergoing cardiothoracic surgery will be assessed for baroreflex sensitivity and the outcomes of interest. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline baroreflex sensitivity
Non-invasive BRS testing with BIOPAC MP160
Measured: 30 min
Secondary outcomes (16)
Postoperative day (POD) 1 baroreflex sensitivity
Non-invasive BRS testing with BIOPAC MP160
Measured: 30 min
POD 2 baroreflex sensitivity
Non-invasive BRS testing with BIOPAC MP160
Measured: 30 min
6 month baroreflex sensitivity
Non-invasive BRS testing with BIOPAC MP160
Measured: 6 months
Acute postoperative pain as assessed by the numeric rating scale (NRS) - 24h
Median NRS pain score in the first 24h after surgery
Measured: 24 hours
Acute postoperative pain as assessed by the numeric rating scale (NRS) - 48h
Median NRS pain score in the second 24h after surgery
Measured: 48 hours
Acute postoperative pain as assessed by the Gracely Box Scale (GBS) - POD1
GBS survey on POD 1
Measured: 15 min
Acute postoperative pain as assessed by the Gracely Box Scale (GBS) - POD2
GBS survey on POD 2
Measured: 15 min
Acute postoperative pain as assessed by the Gracely Box Scale (GBS) - 6 mo
GBS survey at 6 month follow-up visit
Measured: 6 months
Chronic pain as assessed by the change in Brief Pain Inventory score
Change from baseline to 6 months postoperatively
Measured: Baseline, 6 months
Hyperalgesia
Nociceptive threshold as assessed by Von Frey filament testing at 6 month follow-up
Measured: 6 months
Area of hyperalgesia or allodynia
Area surrounding operative incision as assessed by Von Frey filament testing at 6 month follow-up
Measured: 6 months
Postoperative atrial fibrillation
Chart review assessment of the occurrence of postoperative atrial fibrillation during hospitalization and up to 6 weeks postoperatively
Measured: 6 weeks
Postoperative cognitive change
Change from baseline to 6 months in the Mini Mental Status Exam score
Measured: Baseline, 6 months
Baseline psychological distress
As assessed by the Brief Symptom Inventory-18
Measured: 15 min
6 month psychological distress
As assessed by the Brief Symptom Inventory-18
Measured: 6 months
Baseline frailty
As assessed by the Modified Frailty Index
Measured: 10 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2017
- Study start15 Sep 2017
- Primary completion15 Dec 2021
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03243279
- Sponsor's protocol ID
- Pro00083136
- Status last verified
- Feb 2022
- First submitted
- 2 Aug 2017
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Preoperative Baroreflex Sensitivity on Major Outcomes After Cardiothoracic Surgery
- ClinicalTrials.gov ID
- NCT03243279
- Acronym / sponsor ID
- Pro00083136
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 8 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical | – | –No interventions. Patients undergoing cardiothoracic surgery will be assessed for baroreflex sensitivity and the outcomes of interest. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients presenting for cardiac and thoracic surgery at Duke University Hospital, a quaternary referral center
Key inclusion criteria (2 listed)
- >= 18 years of age
- Undergoing cardiac (coronary artery bypass grafting [CABG], CABG + valve, or valve only) or thoracic (video-assisted thoracoscopic [VATS] approach to lobectomy) surgery
Key exclusion criteria (16 listed)
- Any preexisting pain condition (defined as pain of >=3 months duration prior to enrollment)
- Pain at the time of enrollment interview
- Need for preoperative analgesics
- Preexisting chronic or paroxysmal atrial fibrillation
- Preexisting atrial or ventricular arrhythmia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Baseline baroreflex sensitivity
Time frame: 30 min
Non-invasive BRS testing with BIOPAC MP160
16 secondary outcomes
Postoperative day (POD) 1 baroreflex sensitivity
Time frame: 30 min
POD 2 baroreflex sensitivity
Time frame: 30 min
6 month baroreflex sensitivity
Time frame: 6 months
Acute postoperative pain as assessed by the numeric rating scale (NRS) - 24h
Time frame: 24 hours
Acute postoperative pain as assessed by the numeric rating scale (NRS) - 48h
Time frame: 48 hours
Acute postoperative pain as assessed by the Gracely Box Scale (GBS) - POD1
Time frame: 15 min
Acute postoperative pain as assessed by the Gracely Box Scale (GBS) - POD2
Time frame: 15 min
Acute postoperative pain as assessed by the Gracely Box Scale (GBS) - 6 mo
Time frame: 6 months
Chronic pain as assessed by the change in Brief Pain Inventory score
Time frame: Baseline, 6 months
Hyperalgesia
Time frame: 6 months
Area of hyperalgesia or allodynia
Time frame: 6 months
Postoperative atrial fibrillation
Time frame: 6 weeks
Postoperative cognitive change
Time frame: Baseline, 6 months
Baseline psychological distress
Time frame: 15 min
6 month psychological distress
Time frame: 6 months
Baseline frailty
Time frame: 10 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative and Atrial Fibrillation, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline baroreflex sensitivity (time frame: 30 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.