Cardiac SurgeryNCT07785323
Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block for Cardiac Surgery
A study testing Serratus posterior superior intercostal plane block and Standard Perioperative Care in people with Cardiac Surgery and Postoperative Pain, run by Burak Çilingir at 1 site in Turkey (Türkiye).
Trial summary
This prospective, randomized, controlled study aims to evaluate the effects of ultrasound-guided bilateral single-shot serratus posterior superior intercostal plane (SPSIP) block on postoperative recovery and pain management in patients undergoing cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Surgery, Postoperative Pain, Postoperative Recovery After Cardiac Surgery
- What is being tested?
- Serratus posterior superior intercostal plane block and Standard Perioperative Care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Aug 2026to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients aged 18-80 years
- Patients scheduled for elective cardiac surgery
- American Society of Anesthesiologists (ASA) physical status III--IV
- Patients who provide written informed consent to participate in the study
Who cannot join
- Patient refusal to participate in the study
- Known allergy to local anesthetics
- Infection at the site of block application
- Coagulopathy or contraindication to regional anesthesia
- Emergency surgery
- Patients unable to communicate adequately or complete the study assessments
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Adıyaman Training and Research Hospital
Adıyaman, 02100
Burak Çilingir, Resident Physician, +90 552 075 78 85, burakcilingirr@gmail.com
About this study
Official title: The Effect of Ultrasound-Guided Bilateral Single-Shot Serratus Posterior Superior Intercostal Plane Block on Recovery After Cardiac Surgery
This prospective, randomized, controlled study aims to evaluate the effects of ultrasound-guided bilateral single-shot serratus posterior superior intercostal plane (SPSIP) block on postoperative recovery and pain management in patients undergoing cardiac surgery. A total of 50 adult patients will be randomized into two groups: an SPSIP block group and a control group. The investigators will assess postoperative pain, opioid consumption, and quality of recovery during the postoperative period.
Read the detailed description
This prospective, randomized, controlled study will include 50 adult patients undergoing elective cardiac surgery. Patients will be randomly allocated to either the SPSIP block group or the control group.
In the block group, an ultrasound-guided bilateral single-shot serratus posterior superior intercostal plane (SPSIP) block will be performed in addition to the standard perioperative analgesic management. Patients in the control group will receive standard perioperative analgesic management without the SPSIP block.
Postoperative pain intensity will be evaluated using the Numerical Rating Scale (NRS). Postoperative opioid requirements will also be recorded. In addition, postoperative recovery will be assessed using the Quality of Recovery-15T (QoR-15T) questionnaire. Patients will be followed during the postoperative period, including assessments at predefined time points up to 48 hours after surgery.
The primary objective of the study is to determine whether bilateral SPSIP block improves postoperative recovery and provides effective postoperative analgesia in patients undergoing cardiac surgery. Secondary evaluations will include postoperative pain scores and opioid consumption.
- Being tested
- Serratus posterior superior intercostal plane block, Standard Perioperative Care
- Keywords
- Serratus Posterior Superior Intercostal Plane Block, SPSIP Block, Quality of Recovery, QoR-15, QoR-15T, Postoperative Analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus posterior superior intercostal plane blockProcedure or surgery
Also called SPSIP Block
After induction of general anesthesia, an ultrasound-guided bilateral serratus posterior superior intercostal plane (SPSIP) block will be performed at the level of the third rib. Under ultrasound guidance, the needle will be advanced to the fascial plane between the serratus posterior superior muscle and the intercostal muscles. After confirmation of appropriate needle-tip position, 20 mL of 0.25% bupivacaine will be administered on each side. The same procedure will then be performed on the contralateral side.
Standard Perioperative CareProcedure or surgery
Participants in the control group will receive standard perioperative care without serratus posterior superior intercostal plane (SPSIP) block. The perioperative management and postoperative follow-up protocol will otherwise be the same as in the SPSIP block group.
| Study group | Role | What they receive |
|---|---|---|
| SPSIP Block Group | Active comparator | Participants in this group will receive ultrasound-guided bilateral single-shot serratus posterior superior intercostal plane (SPSIP) block in addition to standard perioperative care. Receives: Procedure: Serratus posterior superior intercostal plane block |
| Control Group | Active comparator | Participants in this group will receive standard perioperative care without SPSIP block. Receives: Procedure: Standard Perioperative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Quality of Recovery Assessed by QoR-15T
Postoperative quality of recovery will be assessed using the Turkish version of the Quality of Recovery-15 questionnaire (QoR-15T). The QoR-15T consists of 15 items assessing multiple dimensions of postoperative recovery. The total score ranges from 0 to 150, with higher scores indicating better quality of recovery.
Measured: Postoperative 24 hours
Secondary outcomes (8)
Total Postoperative Tramadol Consumption
Total postoperative tramadol consumption will be recorded as the cumulative amount of tramadol administered during the first 48 hours after surgery. Tramadol consumption will be reported in milligrams (mg).
Measured: From the end of surgery to postoperative 48 hours
Postoperative Pain Intensity
Postoperative pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. VAS scores will be recorded at postoperative 2, 4, 6, 8, 10, 12, 24, 36, and 48 hours.
Measured: Postoperative 2, 4, 6, 8, 10, 12, 24, 36, and 48 hours
Number of Participants With Postoperative Nausea and/or Vomiting (PONV)
The occurrence of postoperative nausea and/or vomiting (PONV) will be assessed at postoperative 2, 4, 6, 8, 10, 12, 24, 36, and 48 hours. At each predefined time point, the presence or absence of nausea and/or vomiting will be recorded as a binary outcome (yes/no). The number of participants experiencing nausea and/or vomiting will be recorded and compared between the groups.
Measured: Postoperative 2, 4, 6, 8, 10, 12, 24, 36, and 48 hours
Intensive Care Unit Length of Stay
The duration of the first postoperative intensive care unit (ICU) stay will be recorded for each participant. ICU length of stay will be calculated from postoperative admission to the ICU until the first discharge from the ICU and will be reported in hours.
Measured: From postoperative ICU admission until first ICU discharge, an average of 7 days
Ward Length of Stay
The duration of postoperative ward stay will be recorded for each participant. Ward length of stay will be calculated from the first discharge from the intensive care unit to hospital discharge and will be reported in days.
Measured: From first ICU discharge until hospital discharge, an average of 14 days
Total Hospital Length of Stay
The total length of hospital stay will be recorded for each participant. Hospital length of stay will be calculated from the day of surgery until hospital discharge and will be reported in days.
Measured: From the day of surgery until hospital discharge, an average of 14 days
Total Duration of Surgery
The total duration of surgery will be recorded for each participant. Surgical duration will be defined as the time from the start of surgery to the completion of surgery and will be reported in minutes.
Measured: Intraoperative period, from the start to the end of surgery
Postoperative Extubation Time
Postoperative extubation time will be defined as the time from the end of surgery to removal of the endotracheal tube and will be recorded in hours.
Measured: From the end of surgery until extubation, an average of 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start20 Aug 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to two parallel groups: the SPSIP block group or the control group. Participants in the SPSIP block group will receive ultrasound-guided bilateral single-shot serratus posterior superior intercostal plane block in addition to standard perioperative care, while participants in the control group will receive standard perioperative care without the block.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Burak Çilingir
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Burak Çilingir, Adiyaman University Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07785323
- Sponsor's protocol ID
- AURH-AR-BC-01
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ultrasound-Guided Bilateral Single-Shot Serratus Posterior Superior Intercostal Plane Block on Recovery After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT07785323
- Acronym / sponsor ID
- AURH-AR-BC-01
- Keywords
- Serratus Posterior Superior Intercostal Plane Block, SPSIP Block, Quality of Recovery, QoR-15, QoR-15T, Postoperative Analgesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Burak ÇilingirUniversity, hospital or other
- Study start
- 20 Aug 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 25 Aug 2026 (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 prospective, randomized, controlled study aims to evaluate the effects of ultrasound-guided bilateral single-shot serratus posterior superior intercostal plane (SPSIP) block on postoperative recovery and pain management in patients undergoing cardiac surgery. A total of 50 adult patients will be randomized into two groups: an SPSIP block group and a control group. The investigators will assess postoperative pain, opioid consumption, and quality of recovery during the postoperative period.
Detailed description
This prospective, randomized, controlled study will include 50 adult patients undergoing elective cardiac surgery. Patients will be randomly allocated to either the SPSIP block group or the control group.
In the block group, an ultrasound-guided bilateral single-shot serratus posterior superior intercostal plane (SPSIP) block will be performed in addition to the standard perioperative analgesic management. Patients in the control group will receive standard perioperative analgesic management without the SPSIP block.
Postoperative pain intensity will be evaluated using the Numerical Rating Scale (NRS). Postoperative opioid requirements will also be recorded. In addition, postoperative recovery will be assessed using the Quality of Recovery-15T (QoR-15T) questionnaire. Patients will be followed during the postoperative period, including assessments at predefined time points up to 48 hours after surgery.
The primary objective of the study is to determine whether bilateral SPSIP block improves postoperative recovery and provides effective postoperative analgesia in patients undergoing cardiac surgery. Secondary evaluations will include postoperative pain scores and opioid consumption.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to two parallel groups: the SPSIP block group or the control group. Participants in the SPSIP block group will receive ultrasound-guided bilateral single-shot serratus posterior superior intercostal plane block in addition to standard perioperative care, while participants in the control group will receive standard perioperative care without the block.
| Arm | Type | Receives |
|---|---|---|
| SPSIP Block Group | Active comparator | Procedure: Serratus posterior superior intercostal plane blockParticipants in this group will receive ultrasound-guided bilateral single-shot serratus posterior superior intercostal plane (SPSIP) block in addition to standard perioperative care. |
| Control Group | Active comparator | Procedure: Standard Perioperative CareParticipants in this group will receive standard perioperative care without SPSIP block. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18-80 years
- Patients scheduled for elective cardiac surgery
- American Society of Anesthesiologists (ASA) physical status III--IV
- Patients who provide written informed consent to participate in the study
Key exclusion criteria (6 listed)
- Patient refusal to participate in the study
- Known allergy to local anesthetics
- Infection at the site of block application
- Coagulopathy or contraindication to regional anesthesia
- Emergency 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 |
|---|---|---|
| Serratus posterior superior intercostal plane blockAlso: SPSIP BlockAfter induction of general anesthesia, an ultrasound-guided bilateral serratus posterior superior intercostal plane (SPSIP) block will be performed at the level of the third rib. Under ultrasound guidance, the needle will be advanced to the fascial plane between the serratus posterior superior muscle and the intercostal muscles. After confirmation of appropriate needle-tip position, 20 mL of 0.25% bupivacaine will be administered on each side. The same procedure will then be performed on the contralateral side. | Procedure or surgery | SPSIP Block Group |
| Standard Perioperative CareParticipants in the control group will receive standard perioperative care without serratus posterior superior intercostal plane (SPSIP) block. The perioperative management and postoperative follow-up protocol will otherwise be the same as in the SPSIP block group. | Procedure or surgery | Control Group |
Primary outcome
Postoperative Quality of Recovery Assessed by QoR-15T
Time frame: Postoperative 24 hours
Postoperative quality of recovery will be assessed using the Turkish version of the Quality of Recovery-15 questionnaire (QoR-15T). The QoR-15T consists of 15 items assessing multiple dimensions of postoperative recovery. The total score ranges from 0 to 150, with higher scores indicating better quality of recovery.
8 secondary outcomes
Total Postoperative Tramadol Consumption
Time frame: From the end of surgery to postoperative 48 hours
Postoperative Pain Intensity
Time frame: Postoperative 2, 4, 6, 8, 10, 12, 24, 36, and 48 hours
Number of Participants With Postoperative Nausea and/or Vomiting (PONV)
Time frame: Postoperative 2, 4, 6, 8, 10, 12, 24, 36, and 48 hours
Intensive Care Unit Length of Stay
Time frame: From postoperative ICU admission until first ICU discharge, an average of 7 days
Ward Length of Stay
Time frame: From first ICU discharge until hospital discharge, an average of 14 days
Total Hospital Length of Stay
Time frame: From the day of surgery until hospital discharge, an average of 14 days
Total Duration of Surgery
Time frame: Intraoperative period, from the start to the end of surgery
Postoperative Extubation Time
Time frame: From the end of surgery until extubation, an average of 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serratus posterior superior intercostal plane block and Standard Perioperative Care in people with Cardiac Surgery and Postoperative Pain, run by Burak Çilingir 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 6 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: opening soon, as of the sponsor's last update on 25 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BURAK ÇİLİNGİR, Resident Physician (+90 552 075 78 85, burakcilingirr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Quality of Recovery Assessed by QoR-15T (time frame: Postoperative 24 hours). 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 25 Aug 2026.