Serratus Anterior Plane BlockNCT06326320
Combined SAPB in MICS
A study testing Combined SAPB in people with Serratus Anterior Plane Block and Acute Pain, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Minimally invasive cardiac surgery (MICS) has begun to be performed frequently in recent years. Compared to sternotomy, MISC reduces the risk of mediastinitis, leaves a more aesthetic scar, facilitates postoperative rehabilitation, and shortens the hospital stay. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Serratus Anterior Plane Block, Acute Pain, Postoperative Analgesia
- What is being tested?
- Combined SAPB
- 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 25 Jun 2025
- 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 40 kg/m2
- Elective Minimally Invasive Cardiac Surgery (MICS)
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 Combined Serratus Anterior Plane Block on Postoperative Acute Pain After Minimally Invasive Cardiac Surgery
Minimally invasive cardiac surgery (MICS) has begun to be performed frequently in recent years. Compared to sternotomy, MISC reduces the risk of mediastinitis, leaves a more aesthetic scar, facilitates postoperative rehabilitation, and shortens the hospital stay. MICS requires a thoracic incision in the right 4th or 5th intercostal space. This incision causes intense and long-lasting pain in the postoperative period. Pain is exacerbated by breathing movements, coughing, and respiratory physiotherapy.
Postoperative analgesia is a critical risk factor for the development of pulmonary and cardiovascular complications in any type of cardiothoracic 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.
Read more
In addition to intravenous medications, various neuraxial and peripheral nerve blocks can be used in cardiac surgery. In recent years, thoracic epidural analgesia has been avoided due to the use of intraoperative high-dose heparin. As an alternative, peripheral nerve blocks have recently gained popularity. SAPB is one of them. SAPB can be applied in three ways. While deep SAPB (DSAPB) is applied under the serratus anterior muscle, superficial SAPB (SSAPB) is applied above the serratus anterior muscle. Combined SAPB (CSAPB) is applied both below and above the serratus anterior muscle. These blocks can be performed with a single injection anywhere between the second and seventh ribs on the lateral chest wall.
In this study, the analgesic effects of ultrasound-guided CSAPB application in patients undergoing MICS will be evaluated.
- Conditions
- Serratus Anterior Plane Block, Acute Pain, Postoperative Analgesia, Minimal Invasive Cardiac Surgery
- Being tested
- Combined SAPB
- 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 SAPBProcedure or surgery
Combined Deep and Superficial Serratus Anterior Plane Block will be performed unilaterally, under US guidance, before the surgical operation, after the induction of anesthesia, when the patient is placed in the supine position. 40 ml of 0.25% bupivacaine will be used in applications.
| Study group | Role | What they receive |
|---|---|---|
| Combined serratus anterior plane block | Other | Following the visualization of the anatomical structures, the nerve block needle will be advanced via the in-plane technique beneath the serratus anterior muscles until the interfascial space was reached. After hydrodissection with 2 ml normal saline, 20 ml 0.25% bupivacaine will be injected into the area. Then, with the same needle, will be returned 1-2 cm from the deep serratus anterior area to superficial serratus anterior area above the serratus anterior muscle and will be injected 2 ml normal saline for hydrodissection. Finally 20ml of 0.25% bupivacaine will be injected for superficial serratus anterior block into the interfacial area. Receives: Procedure: Combined SAPB |
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 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 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 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 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 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 completion10 Jun 2025
- Study completion25 Jun 2025
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 Serratus Anterior Plane BlockStudies 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 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
- NCT06326320
- Sponsor's protocol ID
- E.Kurul-E2-24-6175
- Status last verified
- Jul 2025
- First submitted
- 17 Mar 2024
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zengin EN, Aykut A, Ozgok A, Zengin M, Kucuk O, Yildiz AI, Ungor F, Alagoz A, Salman N, Demir ZA. Feasibility and postoperative analgesic profile of multimodal analgesia including combined serratus anterior plane block in minimally invasive cardiac surgery: a prospective observational study. J Cardiothorac Surg. 2026 Apr 30;21(1):434. doi: 10.1186/s13019-026-04193-8.
PubMed 42063133
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Combined Serratus Anterior Plane Block on Postoperative Acute Pain After Minimally Invasive Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06326320
- Acronym / sponsor ID
- E.Kurul-E2-24-6175
- Conditions
- Serratus Anterior Plane Block, Acute Pain, Postoperative Analgesia, Minimal Invasive 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
- 10 Jun 2025 (actual)
- Study completion
- 25 Jun 2025 (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.
Minimally invasive cardiac surgery (MICS) has begun to be performed frequently in recent years. Compared to sternotomy, MISC reduces the risk of mediastinitis, leaves a more aesthetic scar, facilitates postoperative rehabilitation, and shortens the hospital stay. MICS requires a thoracic incision in the right 4th or 5th intercostal space. This incision causes intense and long-lasting pain in the postoperative period. Pain is exacerbated by breathing movements, coughing, and respiratory physiotherapy.
Postoperative analgesia is a critical risk factor for the development of pulmonary and cardiovascular complications in any type of cardiothoracic 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, thoracic epidural analgesia has been avoided due to the use of intraoperative high-dose heparin. As an alternative, peripheral nerve blocks have recently gained popularity. SAPB is one of them. SAPB can be applied in three ways. While deep SAPB (DSAPB) is applied under the serratus anterior muscle, superficial SAPB (SSAPB) is applied above the serratus anterior muscle. Combined SAPB (CSAPB) is applied both below and above the serratus anterior muscle. These blocks can be performed with a single injection anywhere between the second and seventh ribs on the lateral chest wall.
In this study, the analgesic effects of ultrasound-guided CSAPB application in patients undergoing MICS will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined serratus anterior plane block | Other | Procedure: Combined SAPBFollowing the visualization of the anatomical structures, the nerve block needle will be advanced via the in-plane technique beneath the serratus anterior muscles until the interfascial space was reached. After hydrodissection with 2 ml normal saline, 20 ml 0.25% bupivacaine will be injected into the area. Then, with the same needle, will be returned 1-2 cm from the deep serratus anterior area to superficial serratus anterior area above the serratus anterior muscle and will be injected 2 ml normal saline for hydrodissection. Finally 20ml of 0.25% bupivacaine will be injected for superficial serratus anterior block into the interfacial area. |
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 40 kg/m2
- Elective Minimally Invasive Cardiac Surgery (MICS)
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 SAPBCombined Deep and Superficial Serratus Anterior Plane Block will be performed unilaterally, under US guidance, before the surgical operation, after the induction of anesthesia, when the patient is placed in the supine position. 40 ml of 0.25% bupivacaine will be used in applications. | Procedure or surgery | Combined serratus anterior plane block |
Primary outcome
Pain Scores
Time frame: 0th hour 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 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 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 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 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 11 Jul 2025.
- Derived from this study: PubMed 42063133Zengin EN, Aykut A, Ozgok A, Zengin M, Kucuk O, Yildiz AI, Ungor F, Alagoz A, Salman N, Demir ZA. Feasibility and postoperative analgesic profile of multimodal analgesia including combined serratus anterior plane block in minimally invasive cardiac surgery: a prospective observational study. J Cardiothorac Surg. 2026 Apr 30;21(1):434. doi: 10.1186/s13019-026-04193-8.
Related trials for Serratus Anterior Plane Block
Not yet recruiting
Effect of Serratus and Pectoralis II Plane Block Versus Pectoralis II Alone on Acute Postoperative Pain After Mastectomy
Mastectomy, Mastectomy Plus Axillary Lymph Node Dissection
RecruitingObservational study
Assessment of Morbidity and Mortality Following Serratus Anterior Plane Block (SAPB) for Unilateral Rib Fractures
Pain Management, Rib Fracture Multiple
Not yet recruitingObservational study
Two-Point Versus Single-Point Serratus Anterior Plane Block for Post-Thoracoscopic Surgery Analgesia
Lung Cancer, Pain
Not yet recruiting
Timing of Serratus Anterior Plane Block in Mastectomy Surgery
Quality of Recovery After Mastectomy, Serratus Anterior Plane Block
Active, not recruitingPhase 4
Comparison of the Analgesic Efficacy of Ultrasound-guided Retrolaminar Block Versus Serratus Anterior Plane Block in Patients Undergoing Radical Mastectomy
Serratus Anterior Plane Block
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 SAPB in people with Serratus Anterior Plane Block and Acute Pain, 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 11 Jul 2025. 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 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?
On the ClinicalTrials.gov record for NCT06326320, 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 11 Jul 2025; AzTrials last refreshed its copy on 27 Oct 2026.