Parasternal BlockNCT06326333
Combination of Parasternal and Serratus Anterior Plane Block in Coronary Artery Bypass Graft Surgery
A study testing Combined parasternal block and serratus anterior plane block in people with Parasternal Block and Serratus Anterior Plane Block, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Postoperative analgesia is a critical risk factor for the development of pulmonary and cardiovascular complications in coronary artery bypass graft (CABG) surgery. If patients with high pain levels cannot breathe effectively, it may lead to atelectasis, cardiac ischemia, and arrhythmias. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parasternal Block, Serratus Anterior Plane Block, Acute Pain
- What is being tested?
- Combined parasternal block and serratus anterior plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Feb 2024to 18 Apr 2024
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 80 years old
- American Society of Anesthesiologists (ASA) physical status I-II-III
- BMI 18 to 30 kg/m2
- Elective coronary artery bypass graft (CABG) surgery
Who cannot join
- Patient refusing the procedure
- Emergency surgery
- History of chronic opioid or analgesic used
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Combination of PSB and SAPB on Postoperative Analgesia in Coronary Artery Bypass Graft Surgery
Postoperative analgesia is a critical risk factor for the development of pulmonary and cardiovascular complications in coronary artery bypass graft (CABG) surgery. If patients with high pain levels cannot breathe effectively, it may lead to atelectasis, cardiac ischemia, and arrhythmias. This prolongs the time it takes for patients to be discharged and increases the frequency of postoperative pulmonary complications and postoperative morbidity.
In addition to intravenous medications, various neuraxial and peripheral nerve blocks can be used in cardiac surgery. In recent years, neuraxial anesthesia has been avoided due to the use of intraoperative high-dose heparin. As an alternative, peripheral nerve blocks have recently gained popularity. Parasternal block (PSB) and serratus anterior plane block (SAPB) are very superficial and easy to reach. Recently, in the literature, the number of cases performed with these blocks under ultrasound guidance and the number of randomized controlled prospective studies have increased.
With this study, it was aimed to observe the analgesic effects on both the sternum and the drain site by applying PSB and SAPB applications simultaneously in the postoperative analgesia of CABG patients.
- Conditions
- Parasternal Block, Serratus Anterior Plane Block, Acute Pain, Postoperative Analgesia, Cardiac Surgery
- Being tested
- Combined parasternal block and serratus anterior plane block
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined parasternal block and serratus anterior plane blockProcedure or surgery
The first PSB will be applied to the patients with 7.5 ml of 0.25% bupivacaine under real-time ultrasound guidance at the level of the second intercostal space.
The second PSB will be applied to the patients with 7.5 ml of 0.25% bupivacaine under real-time ultrasound guidance at the level of the fourth intercostal space.
The SAPB will be applied to the patients with 10 ml of 0.25% bupivacaine under real-time ultrasound guidance at the level of the sixth rib in the anterior axillary line.
The block applications will be applied bilaterally.
| Study group | Role | What they receive |
|---|---|---|
| Combined parasternal block and serratus anterior plane block | Other | In the parasternal block application, the needle will be advanced under the pectoralis major muscle and above the intercostal muscle with the ultrasound-guided in-plane technique. 7.5 ml of 0.25% bupivacaine will be injected into this area per each level, at the level of the second and fourth intercostal space.
Then, in the serratus anterior plane block application, in the anterior axillary line, the needle will be advanced under the serratus anterior muscle, above the sixth rib, with the in-plane technique under ultrasound guidance. 10 ml of 0.25% bupivacaine will be injected into this area.
The application will be applied bilaterally. Receives: Procedure: Combined parasternal block and serratus anterior plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores
After the extubation, pain will be assessed for the sternum and the drain area at the 0th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).
Measured: 0th hour of the extubation
Pain Scores
After the extubation, pain will be assessed for the sternum and the drain area at the 2nd-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).
Measured: 2nd hour of the extubation
Pain Scores
After the extubation, pain will be assessed for the sternum and the drain area at the 4th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).
Measured: 4th hour of the extubation
Pain Scores
After the extubation, pain will be assessed for the sternum and the drain area at the 8th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).
Measured: 8th hour of the extubation
Pain Scores
After the extubation, pain will be assessed for the sternum and the drain area at the 12th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).
Measured: 12th hour of the extubation
Secondary outcomes (1)
Remifentanyl Consumption
Remifentanyl consumption for intraoperative period will be recorded
Measured: intraoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start7 Feb 2024
- Primary completion27 Mar 2024
- Study completion18 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parasternal BlockStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilgün Zengin, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06326333
- Sponsor's protocol ID
- E.Kurul-E2-24-6176
- Status last verified
- Apr 2024
- First submitted
- 17 Mar 2024
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Combination of PSB and SAPB on Postoperative Analgesia in Coronary Artery Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT06326333
- Acronym / sponsor ID
- E.Kurul-E2-24-6176
- Conditions
- Parasternal Block, Serratus Anterior Plane Block, Acute Pain, Postoperative Analgesia, Cardiac Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 7 Feb 2024 (actual)
- Primary completion
- 27 Mar 2024 (actual)
- Study completion
- 18 Apr 2024 (actual)
- First posted
- 22 Mar 2024 (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.
Postoperative analgesia is a critical risk factor for the development of pulmonary and cardiovascular complications in coronary artery bypass graft (CABG) surgery. If patients with high pain levels cannot breathe effectively, it may lead to atelectasis, cardiac ischemia, and arrhythmias. This prolongs the time it takes for patients to be discharged and increases the frequency of postoperative pulmonary complications and postoperative morbidity.
In addition to intravenous medications, various neuraxial and peripheral nerve blocks can be used in cardiac surgery. In recent years, neuraxial anesthesia has been avoided due to the use of intraoperative high-dose heparin. As an alternative, peripheral nerve blocks have recently gained popularity. Parasternal block (PSB) and serratus anterior plane block (SAPB) are very superficial and easy to reach. Recently, in the literature, the number of cases performed with these blocks under ultrasound guidance and the number of randomized controlled prospective studies have increased.
With this study, it was aimed to observe the analgesic effects on both the sternum and the drain site by applying PSB and SAPB applications simultaneously in the postoperative analgesia of CABG patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined parasternal block and serratus anterior plane block | Other | Procedure: Combined parasternal block and serratus anterior plane blockIn the parasternal block application, the needle will be advanced under the pectoralis major muscle and above the intercostal muscle with the ultrasound-guided in-plane technique. 7.5 ml of 0.25% bupivacaine will be injected into this area per each level, at the level of the second and fourth intercostal space. Then, in the serratus anterior plane block application, in the anterior axillary line, the needle will be advanced under the serratus anterior muscle, above the sixth rib, with the in-plane technique under ultrasound guidance. 10 ml of 0.25% bupivacaine will be injected into this area. The application will be applied bilaterally. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 to 80 years old
- American Society of Anesthesiologists (ASA) physical status I-II-III
- BMI 18 to 30 kg/m2
- Elective coronary artery bypass graft (CABG) surgery
Key exclusion criteria (3 listed)
- Patient refusing the procedure
- Emergency surgery
- History of chronic opioid or analgesic used
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 |
|---|---|---|
| Combined parasternal block and serratus anterior plane blockThe first PSB will be applied to the patients with 7.5 ml of 0.25% bupivacaine under real-time ultrasound guidance at the level of the second intercostal space. The second PSB will be applied to the patients with 7.5 ml of 0.25% bupivacaine under real-time ultrasound guidance at the level of the fourth intercostal space. The SAPB will be applied to the patients with 10 ml of 0.25% bupivacaine under real-time ultrasound guidance at the level of the sixth rib in the anterior axillary line. The block applications will be applied bilaterally. | Procedure or surgery | Combined parasternal block and serratus anterior plane block |
Primary outcome
Pain Scores
Time frame: 0th hour of the extubation
After the extubation, pain will be assessed for the sternum and the drain area at the 0th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).
Pain Scores
Time frame: 2nd hour of the extubation
After the extubation, pain will be assessed for the sternum and the drain area at the 2nd-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).
Pain Scores
Time frame: 4th hour of the extubation
After the extubation, pain will be assessed for the sternum and the drain area at the 4th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).
Pain Scores
Time frame: 8th hour of the extubation
After the extubation, pain will be assessed for the sternum and the drain area at the 8th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).
Pain Scores
Time frame: 12th hour of the extubation
After the extubation, pain will be assessed for the sternum and the drain area at the 12th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).
1 secondary outcome
Remifentanyl Consumption
Time frame: intraoperative period
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 22 Apr 2024.
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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 study testing Combined parasternal block and serratus anterior plane block in people with Parasternal Block and Serratus Anterior Plane Block, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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 4 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 22 Apr 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 Turkey (Türkiye). 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?
Pain Scores (time frame: 0th hour of the extubation). The study lists 5 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 22 Apr 2024.