Coronary Artery Bypass Graft SurgeryPhase 3NCT05191745
Long-acting Parasternal Blocks for Analgesia After Cardiac Surgery
A Phase 3 study testing Parasternal blocks in people with Coronary Artery Bypass Graft Surgery, run by Jewish General Hospital at 1 site in Canada.
Trial summary
This is a randomized, double-blind, controlled clinical trial is to evaluate the duration of efficacy of parasternal blocks with the use of local anesthetic adjuncts for analgesia after coronary artery bypass grafting surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Bypass Graft Surgery
- What is being tested?
- Parasternal blocks
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 26 Jan 2022to 1 Jun 2024
- Phase
- Phase 3
- 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
Who may be able to join
- Patients coming for elective and urgent coronary artery bypass (CABG)-only surgery.
Who cannot join
- Patients with a history of regular opioid use.
- Patients with a history of chronic pain.
- Patients unable to provide consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-acting Parasternal Blocks for Analgesia After Cardiac Surgery: A Randomized, Controlled, Double-Blinded Clinical Trial
This is a randomized, double-blind, controlled clinical trial is to evaluate the duration of efficacy of parasternal blocks with the use of local anesthetic adjuncts for analgesia after coronary artery bypass grafting surgery.
Read the detailed description
This study will randomize patients to either standard pain control protocols or parasternal blocks after coronary artery bypass grafting-only surgery. This study will specifically examine the effectiveness and duration of analgesia of parasternal blocks with local anesthetic adjuncts, Dexamethasone 10mg and Dexmedetomidine 50mcg, added to the local anesthetic mixture
- Conditions
- Coronary Artery Bypass Graft Surgery
- Being tested
- Parasternal blocks, Standard of care
- Keywords
- Cardiac surgery, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parasternal blocksDrug
Also called pecto-intercostal fascial blocks
Parasternal block with Bupivacaine 0.25% + Epinephrine 1:200,000 x 60cc + Dexamethasone 5mg and Dexmedetomidine 50mcg
Standard of careDrug
All standard management of postoperative pain, as per local protocols
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Patients will receive bilateral parasternal blocks at the end of cardiac surgery. Receives: Drug: Parasternal blocks |
| Control group | Placebo comparator | Patients will receive all standard care as per the hospital protocols. Receives: Drug: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain with inspirometry at 24 hours after surgery
Numerical Rating Scale (NRS) pain score from the sternotomy site during inspirometry. The VAS score is a scale from 0 to 10 where 0 is equivalent to "no pain" and 10 is equal to "the worst imaginable pain"
Measured: 24 hours after surgery
Secondary outcomes (10)
Opioid consumption
Amount of opioid administered (mg of Dilaudid)
Measured: 12, 24 and 48 hours after surgery
Amount of rescue analgesia administered
Amount of ketorolac or ketamine administered
Measured: Total in the first 48 hours after surgery
Pain score at rest
Numerical Rating Scale (NRS) pain score from the sternotomy site during inspirometry. The VAS score is a scale from 0 to 10 where 0 is equivalent to "no pain" and 10 is equal to "the worst imaginable pain"
Measured: 12, 24 and 48 hours after surgery
Pain score with inspirometry
Numerical Rating Scale (NRS) pain score from the sternotomy site during inspirometry. The VAS score is a scale from 0 to 10 where 0 is equivalent to "no pain" and 10 is equal to "the worst imaginable pain"
Measured: 12 and 48 hours after surgery
Intensive Care Unit (ICU) Length of Stay
Time spent in the intensive care unit after surgery (days)
Measured: From surgery until discharge from the ICU, assessed from the date of surgery up until 6 months after the completion of the study
Hospital Length of Stay
Time spent in the hospital after surgery (days)
Measured: From the date of surgery up until discharge from hospital, followed from the date of surgery up until 6 months after the completion of the study
Inspirometry
Volume inspired on inspirometry
Measured: 24 hours after surgery
Patient satisfaction with pain control
0 "extremely unsatisfied" to 10 "extremely satisfied"
Measured: at 48 hours after surgery
Mobilization
Time from ICU arrival to the first mobilization to a chair
Measured: From ICU arrival until first mobilization (approximately first 48 hours postoperatively)
Ambulation
Time from ICU arrival to the first mobilization to a chair
Measured: From ICU arrival until first ambulation (approximately first 72 hours postoperatively)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start26 Jan 2022
- Primary completion28 Apr 2023
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Bypass Graft SurgeryStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jewish General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Cameron, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05191745
- Sponsor's protocol ID
- 2022-3125
- Status last verified
- Jun 2024
- First submitted
- 3 Dec 2021
- Last updated
- 10 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cameron MJ, Long J, Yang SS, Kardash K. How Many Patients Are Needed to Detect a Difference in Pain With Parasternal Blocks? Anesth Analg. 2025 Jul 1;141(1):210-211. doi: 10.1213/ANE.0000000000007355. Epub 2024 Dec 17. No abstract available.
PubMed 39689005
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-acting Parasternal Blocks for Analgesia After Cardiac Surgery: A Randomized, Controlled, Double-Blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT05191745
- Acronym / sponsor ID
- 2022-3125
- Conditions
- Coronary Artery Bypass Graft Surgery
- Keywords
- Cardiac surgery, Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Jewish General HospitalUniversity, hospital or other
- Study start
- 26 Jan 2022 (actual)
- Primary completion
- 28 Apr 2023 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 13 Jan 2022 (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.
This is a randomized, double-blind, controlled clinical trial is to evaluate the duration of efficacy of parasternal blocks with the use of local anesthetic adjuncts for analgesia after coronary artery bypass grafting surgery.
Detailed description
This study will randomize patients to either standard pain control protocols or parasternal blocks after coronary artery bypass grafting-only surgery. This study will specifically examine the effectiveness and duration of analgesia of parasternal blocks with local anesthetic adjuncts, Dexamethasone 10mg and Dexmedetomidine 50mcg, added to the local anesthetic mixture
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Parasternal blocksPatients will receive bilateral parasternal blocks at the end of cardiac surgery. |
| Control group | Placebo comparator | Drug: Standard of carePatients will receive all standard care as per the hospital protocols. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients coming for elective and urgent coronary artery bypass (CABG)-only surgery.
Key exclusion criteria (3 listed)
- Patients with a history of regular opioid use.
- Patients with a history of chronic pain.
- Patients unable to provide consent.
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 |
|---|---|---|
| Parasternal blocksAlso: pecto-intercostal fascial blocksParasternal block with Bupivacaine 0.25% + Epinephrine 1:200,000 x 60cc + Dexamethasone 5mg and Dexmedetomidine 50mcg | Drug | Intervention group |
| Standard of careAll standard management of postoperative pain, as per local protocols | Drug | Control group |
Primary outcome
Pain with inspirometry at 24 hours after surgery
Time frame: 24 hours after surgery
Numerical Rating Scale (NRS) pain score from the sternotomy site during inspirometry. The VAS score is a scale from 0 to 10 where 0 is equivalent to "no pain" and 10 is equal to "the worst imaginable pain"
10 secondary outcomes
Opioid consumption
Time frame: 12, 24 and 48 hours after surgery
Amount of rescue analgesia administered
Time frame: Total in the first 48 hours after surgery
Pain score at rest
Time frame: 12, 24 and 48 hours after surgery
Pain score with inspirometry
Time frame: 12 and 48 hours after surgery
Intensive Care Unit (ICU) Length of Stay
Time frame: From surgery until discharge from the ICU, assessed from the date of surgery up until 6 months after the completion of the study
Hospital Length of Stay
Time frame: From the date of surgery up until discharge from hospital, followed from the date of surgery up until 6 months after the completion of the study
Inspirometry
Time frame: 24 hours after surgery
Patient satisfaction with pain control
Time frame: at 48 hours after surgery
Mobilization
Time frame: From ICU arrival until first mobilization (approximately first 48 hours postoperatively)
Ambulation
Time frame: From ICU arrival until first ambulation (approximately first 72 hours postoperatively)
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 10 Jun 2024.
- Derived from this study: PubMed 39689005Cameron MJ, Long J, Yang SS, Kardash K. How Many Patients Are Needed to Detect a Difference in Pain With Parasternal Blocks? Anesth Analg. 2025 Jul 1;141(1):210-211. doi: 10.1213/ANE.0000000000007355. Epub 2024 Dec 17. No abstract available.
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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?
A Phase 3 study testing Parasternal blocks in people with Coronary Artery Bypass Graft Surgery, run by Jewish General Hospital at 1 site in Canada.
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 1 inclusion and 3 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 10 Jun 2024. 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 Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain with inspirometry at 24 hours after surgery (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05191745, which also lists 1 linked publication.
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 10 Jun 2024.