Pain, PostoperativeNCT04003584
Postop Pain in the MICS Patients Versus Sternotomy Patients
An observational study of Pain, Postoperative and Surgery, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
To adequately assess postoperative pain in the coronary artery bypass surgical population a multicentered retrospective chart review was carried out; the study utilized a nonexperimental comparative descriptive study design. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Surgery
- What is being tested?
- Coronary bypass surgery
- Type of treatment
- Surgery or procedure
- How many people
- 179 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2017to 30 Jan 2018
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The retrospective review was conducted over a six-month time frame, consisting of June 2017 through November 2017, at two hospitals within the same organization. One of the hospitals was a level one trauma center in the center of a major southeastern metropolitan area, and the second was a community hospital within the suburbs of the same city's geographic limits. All included patients fit the above inclusion and exclusion criteria per the aforementioned time frame and involved healthcare centers.
Who may be able to join
- Patients who had an isolated coronary artery bypass surgery at Charlotte Medical Center (CMC) and CMC-Pineville
- Minimally invasive cardiac surgery
- Traditional sternotomy cardiac surgery
Who cannot join
- Documented history of any chronic pain syndromes requiring active treatment
- The "relative" recent requirement of narcotic analgesic use for pain relief prior to operation
- Any CABG operation that inadvertently resulted in an operative surgical complication
- Patient cases that resulted in a readmission within 30 days from surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Postoperative Pain Different in the MICS CABG Cohort V. the Traditional Sternotomy Cohort
To adequately assess postoperative pain in the coronary artery bypass surgical population a multicentered retrospective chart review was carried out; the study utilized a nonexperimental comparative descriptive study design. The retrospective review was conducted over a six-month time frame, consisting of June 2017 through November 2017, at two hospitals within the same organization. The data collection process began in late December of 2017 and January of 2018. The assessment of postop pain was performed by using a standard 11-point numeric pain rating scale on post extubation day one and the day of discharge.
- Conditions
- Pain, Postoperative, Surgery
- Being tested
- Coronary bypass surgery
- Keywords
- Minimally invasive, Cardiac Surgery, Postoperative Pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary bypass surgeryProcedure or surgery
Reviewed postoperative coronary bypass patients and compared postoperative pain levels
| Study group | Role | What they receive |
|---|---|---|
| Minimally Invasive Cardiac Bypass patients | Not described Receives: Procedure: Coronary bypass surgery | |
| Traditional Sternotomy Cardiac Bypass patients | Not described Receives: Procedure: Coronary bypass surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Highest reported pain level, on the standard 0-10 pain scale, post extubation day one
The highest recorded pain level, taken by the nursing staff, on the day following. extubation. Utilized day post due to the washout/possible confounding variable of sedation administration within 24hrs.
Measured: The first 24 hours post extubation
Highest reported pain level, on the standard 0-10 pain scale, on the day of discharge.
The highest reported pain, measured by the nursing staff on within 24hrs from discharge.
Measured: Within 24 hours from discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start1 Jun 2017
- Primary completion30 Jan 2018
- Study completion30 Jan 2018
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 Wake Forest University Health SciencesThe 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
- Retrospective
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeko Madjarov, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04003584
- Sponsor's protocol ID
- IRB file #09-17-29E
- Status last verified
- Jun 2019
- First submitted
- 21 Jun 2019
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If requested we would not mind providing guidance on postoperative pain assessments/likert scales.
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Postoperative Pain Different in the MICS CABG Cohort V. the Traditional Sternotomy Cohort
- ClinicalTrials.gov ID
- NCT04003584
- Acronym / sponsor ID
- IRB file #09-17-29E
- Conditions
- Pain, Postoperative, Surgery
- Keywords
- Minimally invasive, Cardiac Surgery, Postoperative Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 30 Jan 2018 (actual)
- First posted
- 1 Jul 2019 (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.
To adequately assess postoperative pain in the coronary artery bypass surgical population a multicentered retrospective chart review was carried out; the study utilized a nonexperimental comparative descriptive study design. The retrospective review was conducted over a six-month time frame, consisting of June 2017 through November 2017, at two hospitals within the same organization. The data collection process began in late December of 2017 and January of 2018. The assessment of postop pain was performed by using a standard 11-point numeric pain rating scale on post extubation day one and the day of discharge.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimally Invasive Cardiac Bypass patients | – | Procedure: Coronary bypass surgery |
| Traditional Sternotomy Cardiac Bypass patients | – | Procedure: Coronary bypass surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The retrospective review was conducted over a six-month time frame, consisting of June 2017 through November 2017, at two hospitals within the same organization. One of the hospitals was a level one trauma center in the center of a major southeastern metropolitan area, and the second was a community hospital within the suburbs of the same city's geographic limits. All included patients fit the above inclusion and exclusion criteria per the aforementioned time frame and involved healthcare centers.
Key inclusion criteria (3 listed)
- Patients who had an isolated coronary artery bypass surgery at Charlotte Medical Center (CMC) and CMC-Pineville
- Minimally invasive cardiac surgery
- Traditional sternotomy cardiac surgery
Key exclusion criteria (4 listed)
- Documented history of any chronic pain syndromes requiring active treatment
- The "relative" recent requirement of narcotic analgesic use for pain relief prior to operation
- Any CABG operation that inadvertently resulted in an operative surgical complication
- Patient cases that resulted in a readmission within 30 days from surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary bypass surgeryReviewed postoperative coronary bypass patients and compared postoperative pain levels | Procedure or surgery | Minimally Invasive Cardiac Bypass patients, Traditional Sternotomy Cardiac Bypass patients |
Primary outcome
Highest reported pain level, on the standard 0-10 pain scale, post extubation day one
Time frame: The first 24 hours post extubation
The highest recorded pain level, taken by the nursing staff, on the day following. extubation. Utilized day post due to the washout/possible confounding variable of sedation administration within 24hrs.
Highest reported pain level, on the standard 0-10 pain scale, on the day of discharge.
Time frame: Within 24 hours from discharge
The highest reported pain, measured by the nursing staff on within 24hrs from discharge.
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 28 Mar 2023.
- Individual participant dataSharing planned: Undecided. If requested we would not mind providing guidance on postoperative pain assessments/likert scales.
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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.
Jeko Madjarov, MD principal investigator
Wake Forest University Health Sciences
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 Surgery, run by Wake Forest University Health Sciences 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 3 inclusion and 4 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 28 Mar 2023. 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?
Highest reported pain level, on the standard 0-10 pain scale, post extubation day one (time frame: The first 24 hours post extubation). The study lists 2 primary outcomes in all. 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 28 Mar 2023.