PainNCT07420712
Serratus Posterior Superior Intercostal Plane Block in Minimally Invasive Cardiac Surgery
A study testing Serratus Posterior Superior Intercostal Plane Block in people with Pain and Analgesia, run by Kartal Kosuyolu High Speciality Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This single-centre, prospective, randomised controlled trial investigates whether preoperative ultrasound-guided serratus posterior superior intercostal plane block (SPSIPB) reduces postoperative opioid consumption and pain scores in adults undergoing elective minimally invasive cardiac surgery through a right or left… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Serratus Posterior Superior Intercostal Plane Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Feb 2026to 1 Sep 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- American Society of Anesthesiologists physical status I-III
- Elective minimally invasive cardiac surgery through a right or left minithoracotomy, irrespective of the cardiac procedure (coronary artery bypass grafting with or without cardiopulmonary bypass, valve surgery, atrial septal defect closure or cardiac tumour excision)
- Written informed consent
Who cannot join
- Bleeding diathesis
- Anticoagulant therapy
- Known allergy to local anaesthetics, non-steroidal anti-inflammatory drugs or opioids
- Infection at the block site
- Severe preoperative haemodynamic instability or uncontrolled arrhythmia
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kosuyolu High Specialization Training and Research Hospital
Istanbul, 34870
About this study
Official title: Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia in Minimally Invasive Cardiac Surgery Via Thoracotomy: A Randomised Controlled Trial
This single-centre, prospective, randomised controlled trial investigates whether preoperative ultrasound-guided serratus posterior superior intercostal plane block (SPSIPB) reduces postoperative opioid consumption and pain scores in adults undergoing elective minimally invasive cardiac surgery through a right or left minithoracotomy. Patients are randomly allocated in a 1:1 ratio to receive SPSIPB with 30 mL of 0.25% bupivacaine or no block. Both groups receive the same postoperative analgesic regimen, consisting of intravenous paracetamol 1 g every 8 h and intravenous tramadol patient-controlled analgesia. The primary outcome is cumulative tramadol consumption during the first 24 h after extubation. Secondary outcomes include postoperative pain scores, intraoperative remifentanil consumption and haemodynamic responses.
Read the detailed description
Study design and setting: This is a single-centre, prospective, randomised controlled, parallel-group trial with a 1:1 allocation ratio, conducted at Kosuyolu High Specialization Education and Research Hospital, Istanbul, Turkey. Ethics committee approval (2025/12/1164) covers elective minimally invasive cardiac procedures performed through a right or left minithoracotomy.
Participants: Adults with American Society of Anesthesiologists (ASA) physical status I-III who are scheduled for elective minimally invasive cardiac surgery through a right or left minithoracotomy, irrespective of the cardiac procedure (coronary artery bypass grafting with or without cardiopulmonary bypass, valve surgery, atrial septal defect closure or cardiac tumour excision).
Randomisation and blinding: An investigator who is not involved in block performance or outcome assessment generates the allocation sequence using block randomisation (block size of six; 1:1 allocation) and places assignments in sequentially numbered, sealed, opaque envelopes. The principal investigator, who performs all blocks, opens the envelope immediately before the procedure. The anaesthesiologist responsible for intraoperative management, surgical team, intensive care unit staff, nurses and acute pain team performing postoperative assessments are unaware of group allocation. Patients are not explicitly informed of their allocation; no sham block is performed in the control group.
Intervention: In the SPSIPB group, ultrasound-guided serratus posterior superior intercostal plane block is performed in the block room approximately 30 min before transfer to the operating room, with the patient in the lateral decubitus position and the operative side uppermost. The needle is advanced in-plane in a caudocranial direction until its tip is positioned between the serratus posterior superior muscle and the third rib, followed by injection of 30 mL of 0.25% bupivacaine. No regional block is performed in the control group.
Anaesthesia and analgesia: General anaesthesia is standardised in both groups using propofol, rocuronium and sevoflurane. Intraoperative remifentanil infusion is titrated to maintain systolic blood pressure within ±20% of the pre-incision value. Postoperatively, all patients receive intravenous paracetamol 1 g every 8 h and intravenous tramadol patient-controlled analgesia (10-mg bolus, 15-min lockout interval, no basal infusion, maximum 100 mg over 4 h and 400 mg over 24 h). Intravenous tenoxicam 20 mg is administered as rescue analgesia for a numeric rating scale (NRS) score ≥4 at rest and/or on movement.
Assessments and outcomes: The primary outcome is cumulative tramadol consumption recorded from the patient-controlled analgesia device during the first 24 h after extubation. Blinded nurses and the acute pain team assess NRS pain scores at rest and during shoulder flexion, as well as postoperative nausea and vomiting, at 1, 4, 8, 16 and 24 h after extubation. Secondary outcomes include rescue analgesia requirements, intraoperative remifentanil consumption, the change in systolic blood pressure 1 min after skin incision, time to extubation and intensive care unit length of stay. The timing of the first rescue analgesic dose and other perioperative haemodynamic variables are also recorded.
- Being tested
- Serratus Posterior Superior Intercostal Plane Block
- Keywords
- Serratus posterior superior intercostal plane block (SPSIPB), minimally invasive cardiac surgery, minithoracotomy, regional anaesthesia, postoperative analgesia
- Medical subject headings
- Pain, Agnosia
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
Procedure: Serratus posterior superior intercostal plane block With the patient in the lateral decubitus position (operative side up), an 80-mm, 22-G block needle is advanced in-plane in a caudocranial direction under ultrasound guidance until its tip lies between the serratus posterior superior muscle and the third rib; after hydrodissection with 1-2 mL of saline, 30 mL of 0.25% bupivacaine is injected. The block is performed approximately 30 min before transfer to the operating room.
Other name: SPSIPB Arm: SPSIPB group
.
| Study group | Role | What they receive |
|---|---|---|
| SPSIPB Group | Experimental | Ultrasound-guided serratus posterior superior intercostal plane block on the side of the thoracotomy (30 mL of 0.25% bupivacaine), performed before induction of general anaesthesia, plus standard postoperative analgesia (intravenous paracetamol 1 g every 8 h and intravenous tramadol patient-controlled analgesia). Receives: Procedure: Serratus Posterior Superior Intercostal Plane Block |
| Control Group | No intervention | No regional block. Standard postoperative analgesia only (intravenous paracetamol 1 g every 8 h and intravenous tramadol patient-controlled analgesia). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative tramadol consumption
Total tramadol delivered by intravenous patient-controlled analgesia (mg).
Measured: First 24 hours after extubation
Secondary outcomes (8)
Resting pain scores 1 to 24 hours after extubation
Pain at rest on the NRS (0-10).
Measured: 1, 4, 8, 16 and 24 hours after extubation
Pain scores on movement
Pain during shoulder flexion on the NRS (0-10).
Measured: 1, 4, 8, 16 and 24 hours after extubation
Rescue analgesia requirement
Number of patients who receive intravenous tenoxicam 20 mg as rescue analgesia for an NRS score ≥ 4 at rest and/or on movement.
Measured: First 24 hours after extubation
Intraoperative remifentanil consumption
Total remifentanil infused during surgery (µg).
Measured: From induction of anaesthesia to the end of surgery
Change in systolic blood pressure at skin incision
Change in invasive systolic blood pressure from the pre-incision value to 1 minute after skin incision (mmHg).
Measured: Immediately before and 1 minute after skin incision
Postoperative nausea and vomiting
Number of patients with nausea or vomiting, defined as a highest score ≥ 1 within 24 hours on a 0-3 scale (0 = none; 1 = nausea without vomiting; 2 = a single episode of vomiting or persistent nausea; 3 = recurrent vomiting or severe retching), assessed at 1, 4, 8, 16 and 24 hours after extubation.
Measured: First 24 hours after extubation
Time to extubation
Time from the end of surgery to tracheal extubation (h).
Measured: From the end of surgery to extubation, up to 24 hours
Length of intensive care unit stay
Time from intensive care unit admission to discharge (h).
Measured: From intensive care unit admission to discharge, up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start20 Feb 2026
- Primary completion1 Sep 2026
- Study completion1 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Single-centre, prospective, randomised, controlled, parallel-group trial with 1:1 allocation.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kartal Kosuyolu High Speciality Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mustafa Burgaç, Kartal Kosuyolu High Speciality Training and Research Hospital
- Investigators
- Mustafa Burgaç, himself, Principal investigator, mustafaburgac@outlook.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07420712
- Sponsor's protocol ID
- 2025/12/1164
- Status last verified
- Oct 2026
- First submitted
- 4 Feb 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published results, the study protocol and the statistical analysis code will be available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia in Minimally Invasive Cardiac Surgery Via Thoracotomy: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07420712
- Acronym / sponsor ID
- 2025/12/1164
- Keywords
- Serratus posterior superior intercostal plane block (SPSIPB), minimally invasive cardiac surgery, minithoracotomy, regional anaesthesia, postoperative analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Kartal Kosuyolu High Speciality Training and Research HospitalOther government
- Study start
- 20 Feb 2026 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 19 Feb 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 single-centre, prospective, randomised controlled trial investigates whether preoperative ultrasound-guided serratus posterior superior intercostal plane block (SPSIPB) reduces postoperative opioid consumption and pain scores in adults undergoing elective minimally invasive cardiac surgery through a right or left minithoracotomy. Patients are randomly allocated in a 1:1 ratio to receive SPSIPB with 30 mL of 0.25% bupivacaine or no block. Both groups receive the same postoperative analgesic regimen, consisting of intravenous paracetamol 1 g every 8 h and intravenous tramadol patient-controlled analgesia. The primary outcome is cumulative tramadol consumption during the first 24 h after extubation. Secondary outcomes include postoperative pain scores, intraoperative remifentanil consumption and haemodynamic responses.
Detailed description
Study design and setting: This is a single-centre, prospective, randomised controlled, parallel-group trial with a 1:1 allocation ratio, conducted at Kosuyolu High Specialization Education and Research Hospital, Istanbul, Turkey. Ethics committee approval (2025/12/1164) covers elective minimally invasive cardiac procedures performed through a right or left minithoracotomy.
Participants: Adults with American Society of Anesthesiologists (ASA) physical status I-III who are scheduled for elective minimally invasive cardiac surgery through a right or left minithoracotomy, irrespective of the cardiac procedure (coronary artery bypass grafting with or without cardiopulmonary bypass, valve surgery, atrial septal defect closure or cardiac tumour excision).
Randomisation and blinding: An investigator who is not involved in block performance or outcome assessment generates the allocation sequence using block randomisation (block size of six; 1:1 allocation) and places assignments in sequentially numbered, sealed, opaque envelopes. The principal investigator, who performs all blocks, opens the envelope immediately before the procedure. The anaesthesiologist responsible for intraoperative management, surgical team, intensive care unit staff, nurses and acute pain team performing postoperative assessments are unaware of group allocation. Patients are not explicitly informed of their allocation; no sham block is performed in the control group.
Intervention: In the SPSIPB group, ultrasound-guided serratus posterior superior intercostal plane block is performed in the block room approximately 30 min before transfer to the operating room, with the patient in the lateral decubitus position and the operative side uppermost. The needle is advanced in-plane in a caudocranial direction until its tip is positioned between the serratus posterior superior muscle and the third rib, followed by injection of 30 mL of 0.25% bupivacaine. No regional block is performed in the control group.
Anaesthesia and analgesia: General anaesthesia is standardised in both groups using propofol, rocuronium and sevoflurane. Intraoperative remifentanil infusion is titrated to maintain systolic blood pressure within ±20% of the pre-incision value. Postoperatively, all patients receive intravenous paracetamol 1 g every 8 h and intravenous tramadol patient-controlled analgesia (10-mg bolus, 15-min lockout interval, no basal infusion, maximum 100 mg over 4 h and 400 mg over 24 h). Intravenous tenoxicam 20 mg is administered as rescue analgesia for a numeric rating scale (NRS) score ≥4 at rest and/or on movement.
Assessments and outcomes: The primary outcome is cumulative tramadol consumption recorded from the patient-controlled analgesia device during the first 24 h after extubation. Blinded nurses and the acute pain team assess NRS pain scores at rest and during shoulder flexion, as well as postoperative nausea and vomiting, at 1, 4, 8, 16 and 24 h after extubation. Secondary outcomes include rescue analgesia requirements, intraoperative remifentanil consumption, the change in systolic blood pressure 1 min after skin incision, time to extubation and intensive care unit length of stay. The timing of the first rescue analgesic dose and other perioperative haemodynamic variables are also recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Single-centre, prospective, randomised, controlled, parallel-group trial with 1:1 allocation.
| Arm | Type | Receives |
|---|---|---|
| SPSIPB Group | Experimental | Procedure: Serratus Posterior Superior Intercostal Plane BlockUltrasound-guided serratus posterior superior intercostal plane block on the side of the thoracotomy (30 mL of 0.25% bupivacaine), performed before induction of general anaesthesia, plus standard postoperative analgesia (intravenous paracetamol 1 g every 8 h and intravenous tramadol patient-controlled analgesia). |
| Control Group | No intervention | –No regional block. Standard postoperative analgesia only (intravenous paracetamol 1 g every 8 h and intravenous tramadol patient-controlled analgesia). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older
- American Society of Anesthesiologists physical status I-III
- Elective minimally invasive cardiac surgery through a right or left minithoracotomy, irrespective of the cardiac procedure (coronary artery bypass grafting with or without cardiopulmonary bypass, valve surgery, atrial septal defect closure or cardiac tumour excision)
- Written informed consent
Key exclusion criteria (6 listed)
- Bleeding diathesis
- Anticoagulant therapy
- Known allergy to local anaesthetics, non-steroidal anti-inflammatory drugs or opioids
- Infection at the block site
- Severe preoperative haemodynamic instability or uncontrolled arrhythmia
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 BlockProcedure: Serratus posterior superior intercostal plane block With the patient in the lateral decubitus position (operative side up), an 80-mm, 22-G block needle is advanced in-plane in a caudocranial direction under ultrasound guidance until its tip lies between the serratus posterior superior muscle and the third rib; after hydrodissection with 1-2 mL of saline, 30 mL of 0.25% bupivacaine is injected. The block is performed approximately 30 min before transfer to the operating room. Other name: SPSIPB Arm: SPSIPB group . | Procedure or surgery | SPSIPB Group |
Primary outcome
Cumulative tramadol consumption
Time frame: First 24 hours after extubation
Total tramadol delivered by intravenous patient-controlled analgesia (mg).
8 secondary outcomes
Resting pain scores 1 to 24 hours after extubation
Time frame: 1, 4, 8, 16 and 24 hours after extubation
Pain scores on movement
Time frame: 1, 4, 8, 16 and 24 hours after extubation
Rescue analgesia requirement
Time frame: First 24 hours after extubation
Intraoperative remifentanil consumption
Time frame: From induction of anaesthesia to the end of surgery
Change in systolic blood pressure at skin incision
Time frame: Immediately before and 1 minute after skin incision
Postoperative nausea and vomiting
Time frame: First 24 hours after extubation
Time to extubation
Time frame: From the end of surgery to extubation, up to 24 hours
Length of intensive care unit stay
Time frame: From intensive care unit admission to discharge, up to 10 days
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 26 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the published results, the study protocol and the statistical analysis code will be available from the corresponding author on reasonable request.
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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.
Mustafa Burgaç, himself principal investigator
mustafaburgac@outlook.com
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 in people with Pain and Analgesia, run by Kartal Kosuyolu High Speciality Training and Research Hospital 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: finished, as of the sponsor's last update on 26 Oct 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?
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?
Cumulative tramadol consumption (time frame: First 24 hours after extubation). 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 26 Oct 2026.