- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06326333
Combination of Parasternal and Serratus Anterior Plane Block in Coronary Artery Bypass Graft Surgery
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Emine Nilgün N Zengin, MD
- Phone Number: +905063370548
- Email: nilbavullu@gmail.com
Study Contact Backup
- Name: Aslı Demir, MD
- Phone Number: 00905052491598
- Email: zaslidem@yahoo.com
Study Locations
-
-
Ankara
-
Çankaya, Ankara, Turkey, 06290
- Ankara City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patient refusing the procedure
- Emergency surgery
- History of chronic opioid or analgesic used
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Combined parasternal block and serratus anterior plane block
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. |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
0th hour of the extubation
|
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).
|
2nd hour of the extubation
|
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).
|
4th hour of the extubation
|
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).
|
8th hour of the extubation
|
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).
|
12th hour of the extubation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Remifentanyl Consumption
Time Frame: intraoperative period
|
Remifentanyl consumption for intraoperative period will be recorded
|
intraoperative period
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E.Kurul-E2-24-6176
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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