Heart Valvular DiseaseSPSIPB-MICSNCT07259824
SPSIP Block and Opioid Use After MICS
A study testing Serratus Posterior Superior Intercostal Plane Block (SPSIPB) in people with Heart Valvular Disease and Minimally Invasive Cardiac Surgery, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
This prospective, randomized, controlled, single-center clinical study aims to evaluate the effectiveness of the Serratus Posterior Superior Intercostal Plane Block (SPSIPB) in perioperative pain management among patients undergoing minimally invasive cardiac surgery (MICS). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Valvular Disease, Minimally Invasive Cardiac Surgery, Postoperative Pain Management
- What is being tested?
- Serratus Posterior Superior Intercostal Plane Block (SPSIPB)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Jan 2026to 22 Apr 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective minimally invasive cardiac surgery (MICS)
- Age between 18 and 75 years
- American Society of Anesthesiologists (ASA) physical status II-III
- Body mass index (BMI) between 18 and 35 kg/m²
- Patients who provide written informed consent for participation
Who cannot join
- Known allergy or hypersensitivity to local anesthetics
- Coagulopathy or current anticoagulant therapy
- Pregnancy or breastfeeding
- Impaired consciousness or inability to communicate
- Failed or technically inadequate block
- Refusal to undergo the block procedure
Show all 10Show fewer
- Cognitive or mental disorders preventing valid pain assessment
- Opioid intolerance or contraindication to opioid use
- Development of intraoperative or postoperative complications requiring reoperation, prolonged mechanical ventilation, or intensive care
- Incomplete postoperative data or patient withdrawal from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effectiveness of Serratus Posterior Superior Intercostal Plane Block in Perioperative Pain Management in Patients Undergoing Minimally Invasive Cardiac Surgery
This prospective, randomized, controlled, single-center clinical study aims to evaluate the effectiveness of the Serratus Posterior Superior Intercostal Plane Block (SPSIPB) in perioperative pain management among patients undergoing minimally invasive cardiac surgery (MICS). A total of 50 patients undergoing MICS will be randomized into two groups: one receiving standard analgesia plus ultrasound-guided SPSIPB with 30 mL of 0.25% bupivacaine, and a control group receiving standard analgesia only. The primary outcome is total postoperative opioid consumption within 24 hours. Secondary outcomes include postoperative pain scores, extubation time, block-related complications, and recovery parameters such as early mobilization, oral intake, Modified radiological atelectasis score and Quality of Recovery-15 scores.
Read the detailed description
Minimally invasive cardiac surgery (MICS) is increasingly performed as an alternative to traditional sternotomy-based procedures, providing benefits such as shorter recovery time, reduced hospital stay, and improved cosmetic outcomes. However, despite smaller incisions, patients frequently experience moderate to severe postoperative pain due to rib, pleural, and intercostal nerve injury. Uncontrolled pain may impair respiratory function, delay mobilization, and increase postoperative complications, including chronic post-thoracotomy pain.
Regional anesthesia techniques play an important role in multimodal analgesia after MICS, but the optimal approach remains uncertain. Thoracic epidural and paravertebral blocks have been widely used but are often limited by safety concerns in anticoagulated patients. Recently, ultrasound-guided interfascial plane blocks have gained attention due to their simplicity and low complication rates. The Serratus Posterior Superior Intercostal Plane Block (SPSIPB), first described in 2023, targets the fascial plane between the serratus posterior superior and intercostal muscles, typically at the second or third intercostal level, and provides broad sensory coverage from C3 to T10 dermatomes. To date, there is no published study investigating its use for pain control in MICS.
This study will be conducted at Ankara Bilkent City Hospital as a prospective, randomized, controlled, single-center clinical trial. A total of 50 patients (25 per group) aged 18-75 years (ASA II-III) scheduled for MICS will be enrolled after obtaining informed consent. Participants will be randomly assigned (1:1) to one of two groups using a computer-based randomization method:
Group SPSIPB (n=25): Standard anesthesia and analgesia + ultrasound-guided SPSIPB with 30 mL of 0.25% bupivacaine (unilateral, on the surgical side).
Group Control (n=25): Standard anesthesia and analgesia only. All patients will receive intravenous tramadol (1 mg/kg) and paracetamol (1 g) at the end of surgery. Postoperative patient-controlled analgesia (PCA) with tramadol (15 mg bolus, 15-min lockout, no basal infusion) will be used in both groups. Rescue morphine (0.05 mg/kg) will be administered when NRS >4. Pain scores (NRS 0-10) will be recorded at 6, 12, and 24 hours postoperatively, both at rest and during deep breathing/coughing.
The primary outcome is total postoperative opioid consumption (morphine equivalent, mg) in the first 24 hours.
Secondary outcomes include intraoperative opioid use, postoperative pain scores, extubation time, block-related complications (e.g., pneumothorax, vascular puncture, hematoma, local anesthetic toxicity), postoperative recovery indicators (first oral intake, mobilization, respiratory function), Modified radiological atelectasis score, Quality of Recovery-15 (QoR-15) scores.
All postoperative assessments will be performed by a blinded senior anesthesia resident unaware of group allocation. Statistical analysis will be conducted using SPSS v26. Continuous variables will be analyzed with the independent t-test or Mann-Whitney U test as appropriate; categorical variables will be evaluated with chi-square or Fisher's exact test. Repeated pain scores will be compared using repeated-measures ANOVA or Friedman test. A p value <0.05 will be considered statistically significant.
The study is expected to start in January 2026. The results may provide new evidence on the effectiveness and safety of SPSIPB for postoperative analgesia in minimally invasive cardiac surgery.
- Conditions
- Heart Valvular Disease, Minimally Invasive Cardiac Surgery, Postoperative Pain Management, Serratus Posterior Superior Intercostal Plane Block
- Being tested
- Serratus Posterior Superior Intercostal Plane Block (SPSIPB), Sham Serratus Posterior Superior Intercostal Plane Block
- Keywords
- postoperative pain management, minimally invasive cardiac surgery, serratus posterior superior intercostal plane block, opioid consumption
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus Posterior Superior Intercostal Plane Block (SPSIPB)Procedure or surgery
The SPSIPB will be performed under ultrasound guidance using an in-plane technique. The needle will be advanced into the fascial plane between the serratus posterior superior and intercostal muscles at the 2nd-3rd intercostal level, and 30 mL of 0.25% bupivacaine will be injected unilaterally on the surgical side. This procedure will be applied in addition to standard anesthesia and analgesia.
Sham Serratus Posterior Superior Intercostal Plane BlockProcedure or surgery
The same ultrasound-guided procedure will be performed using identical technique and needle placement, but 30 mL of normal saline will be injected instead of local anesthetic. This sham block will be performed to maintain blinding, while all other anesthesia and analgesia protocols will be identical to the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| SPSIPB Group | Experimental | Patients in this group will receive ultrasound-guided Serratus Posterior Superior Intercostal Plane Block (SPSIPB) with 30 mL of 0.25% bupivacaine in addition to standard anesthesia and analgesia. Receives: Procedure: Serratus Posterior Superior Intercostal Plane Block (SPSIPB) |
| Sham Block Group | Sham comparator | Patients in this group will undergo the same ultrasound-guided block procedure using identical technique and needle placement, but 30 mL of normal saline will be injected instead of local anesthetic. All other anesthesia and analgesia protocols will be identical to the experimental group. Receives: Procedure: Sham Serratus Posterior Superior Intercostal Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total opioid consumption within 24 hours after surgery
The total amount of opioids (converted to intravenous morphine equivalent, mg) administered during the first 24 postoperative hours will be recorded from the patient-controlled analgesia (PCA) device and rescue analgesic doses.
Measured: 24 hours postoperatively
Secondary outcomes (7)
Postoperative pain scores (NRS)
Pain intensity will be assessed using the Numeric Rating Scale (0 = no pain, 10 = worst imaginable pain) at rest and during deep breathing/coughing.
Measured: 6, 12, and 24 hours postoperatively
Extubation time
Time from the end of surgery to tracheal extubation (minutes).
Measured: Immediate postoperative period
Intraoperative opioid consumption
Total intraoperative opioid dose.
Measured: During surgery
Block-related complications
Incidence of pneumothorax, vascular puncture, hematoma, local anesthetic systemic toxicity, or injection site pain.
Measured: Within 24 hours postoperatively
Postoperative recovery parameters
Time to first oral intake, time to first mobilization assesment
Measured: Within 48 hours postoperatively
Quality of Recovery (QoR-15) score
Patient recovery quality will be assessed using the validated QoR-15 questionnaire.The QoR-15 is a patient-reported outcome measure consisting of 15 items scored from 0 to 10. The total score ranges from 0 (extremely poor recovery) to 150 (excellent recovery), with higher scores reflecting better postoperative quality of recovery.
Measured: 24 and 48 hours postoperatively
Modified Radiological Atelectasis Score
modified radiological atelectasis score will be evaluated at 24 and 48 hours after surgery. Each lung lobe, including the lingula, is scored from 0 (normal) to 3 (total atelectasis), with higher total scores indicating more severe atelectasis.
Measured: 24 and 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start22 Jan 2026
- Primary completion15 Apr 2026
- Study completion22 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Heart Valvular DiseaseStudies 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
- This is a prospective, randomized, controlled, parallel-group clinical trial conducted at a single center. Eligible patients scheduled for minimally invasive cardiac surgery will be randomly assigned in a 1:1 ratio to receive either the Serratus Posterior Superior Intercostal Plane Block (SPSIPB) in addition to standard analgesia or standard analgesia alone. Both groups will be managed and evaluated under the same perioperative protocol, and outcomes will be assessed by blinded observers.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nisan Özsan, Ankara City Hospital Bilkent
- Investigators
- Zeliha A Demir, M.D., Principal investigator, Ankara Bilkent City Hospital, Department of Anesthesiology and Reanimation, Professor of AneshesiologyAslıhan Aykut, M.D., Study director, Ankara Bilkent City Hospital, Department of Anesthesiology and Reanimation, Associate Professor of AnesthesiologyNisan Özsan, M.D., Study chair, Ankara Bilkent City Hospital, Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07259824
- Sponsor's protocol ID
- NisanOzsan
- Acronym
- SPSIPB-MICS
- Status last verified
- Jan 2026
- First submitted
- 21 Nov 2025
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a single-center academic study. Individual participant data will not be shared publicly. Aggregate results will be reported in publication.
Publications
Turan EI, Isik S, Baydemir AE, Sahin AS. Serratus posterior superior intercostal plane block for postoperative analgesia in clavicle surgeries: new indications for a novel block. Minerva Anestesiol. 2024 Nov;90(11):1058-1060. doi: 10.23736/S0375-9393.24.18275-2. Epub 2024 Aug 5. No abstract available.
PubMed 39101308Avci O, Gundogdu O, Balci F, Tekcan MN, Ozbey M. Efficacy of serratus posterior superior intercostal plane block (SPSIPB) on post-operative pain and total analgesic consumption in patients undergoing video-assisted thoracoscopic surgery (VATS): A double-blinded randomised controlled trial. Indian J Anaesth. 2023 Dec;67(12):1116-1122. doi: 10.4103/ija.ija_589_23. Epub 2023 Dec 13.
PubMed 38343684Shimizu C, Wakimoto M, Kita T. Efficacy of epidural anesthesia in minimally invasive cardiac surgery. Saudi J Anaesth. 2024 Oct-Dec;18(4):528-533. doi: 10.4103/sja.sja_334_24. Epub 2024 Oct 2.
PubMed 39600439Dost B, Turunc E, Aydin ME, Kaya C, Aykut A, Demir ZA, Narayanan M, De Cassai A. Pain Management in Minimally Invasive Cardiac Surgery: A Review of Current Clinical Evidence. Pain Ther. 2025 Jun;14(3):913-930. doi: 10.1007/s40122-025-00739-1. Epub 2025 Apr 24.
PubMed 40272720Piekarski F, Rohner M, Monsefi N, Bakhtiary F, Velten M. Anesthesia for Minimal Invasive Cardiac Surgery: The Bonn Heart Center Protocol. J Clin Med. 2024 Jul 5;13(13):3939. doi: 10.3390/jcm13133939.
PubMed 38999504
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Serratus Posterior Superior Intercostal Plane Block in Perioperative Pain Management in Patients Undergoing Minimally Invasive Cardiac Surgery
- ClinicalTrials.gov ID
- NCT07259824
- Acronym / sponsor ID
- SPSIPB-MICS / NisanOzsan
- Conditions
- Heart Valvular Disease, Minimally Invasive Cardiac Surgery, Postoperative Pain Management, Serratus Posterior Superior Intercostal Plane Block
- Keywords
- postoperative pain management, minimally invasive cardiac surgery, serratus posterior superior intercostal plane block, opioid consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 22 Jan 2026 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 22 Apr 2026 (actual)
- First posted
- 2 Dec 2025 (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, single-center clinical study aims to evaluate the effectiveness of the Serratus Posterior Superior Intercostal Plane Block (SPSIPB) in perioperative pain management among patients undergoing minimally invasive cardiac surgery (MICS). A total of 50 patients undergoing MICS will be randomized into two groups: one receiving standard analgesia plus ultrasound-guided SPSIPB with 30 mL of 0.25% bupivacaine, and a control group receiving standard analgesia only. The primary outcome is total postoperative opioid consumption within 24 hours. Secondary outcomes include postoperative pain scores, extubation time, block-related complications, and recovery parameters such as early mobilization, oral intake, Modified radiological atelectasis score and Quality of Recovery-15 scores.
Detailed description
Minimally invasive cardiac surgery (MICS) is increasingly performed as an alternative to traditional sternotomy-based procedures, providing benefits such as shorter recovery time, reduced hospital stay, and improved cosmetic outcomes. However, despite smaller incisions, patients frequently experience moderate to severe postoperative pain due to rib, pleural, and intercostal nerve injury. Uncontrolled pain may impair respiratory function, delay mobilization, and increase postoperative complications, including chronic post-thoracotomy pain.
Regional anesthesia techniques play an important role in multimodal analgesia after MICS, but the optimal approach remains uncertain. Thoracic epidural and paravertebral blocks have been widely used but are often limited by safety concerns in anticoagulated patients. Recently, ultrasound-guided interfascial plane blocks have gained attention due to their simplicity and low complication rates. The Serratus Posterior Superior Intercostal Plane Block (SPSIPB), first described in 2023, targets the fascial plane between the serratus posterior superior and intercostal muscles, typically at the second or third intercostal level, and provides broad sensory coverage from C3 to T10 dermatomes. To date, there is no published study investigating its use for pain control in MICS.
This study will be conducted at Ankara Bilkent City Hospital as a prospective, randomized, controlled, single-center clinical trial. A total of 50 patients (25 per group) aged 18-75 years (ASA II-III) scheduled for MICS will be enrolled after obtaining informed consent. Participants will be randomly assigned (1:1) to one of two groups using a computer-based randomization method:
Group SPSIPB (n=25): Standard anesthesia and analgesia + ultrasound-guided SPSIPB with 30 mL of 0.25% bupivacaine (unilateral, on the surgical side).
Group Control (n=25): Standard anesthesia and analgesia only. All patients will receive intravenous tramadol (1 mg/kg) and paracetamol (1 g) at the end of surgery. Postoperative patient-controlled analgesia (PCA) with tramadol (15 mg bolus, 15-min lockout, no basal infusion) will be used in both groups. Rescue morphine (0.05 mg/kg) will be administered when NRS >4. Pain scores (NRS 0-10) will be recorded at 6, 12, and 24 hours postoperatively, both at rest and during deep breathing/coughing.
The primary outcome is total postoperative opioid consumption (morphine equivalent, mg) in the first 24 hours.
Secondary outcomes include intraoperative opioid use, postoperative pain scores, extubation time, block-related complications (e.g., pneumothorax, vascular puncture, hematoma, local anesthetic toxicity), postoperative recovery indicators (first oral intake, mobilization, respiratory function), Modified radiological atelectasis score, Quality of Recovery-15 (QoR-15) scores.
All postoperative assessments will be performed by a blinded senior anesthesia resident unaware of group allocation. Statistical analysis will be conducted using SPSS v26. Continuous variables will be analyzed with the independent t-test or Mann-Whitney U test as appropriate; categorical variables will be evaluated with chi-square or Fisher's exact test. Repeated pain scores will be compared using repeated-measures ANOVA or Friedman test. A p value <0.05 will be considered statistically significant.
The study is expected to start in January 2026. The results may provide new evidence on the effectiveness and safety of SPSIPB for postoperative analgesia in minimally invasive cardiac surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective, randomized, controlled, parallel-group clinical trial conducted at a single center. Eligible patients scheduled for minimally invasive cardiac surgery will be randomly assigned in a 1:1 ratio to receive either the Serratus Posterior Superior Intercostal Plane Block (SPSIPB) in addition to standard analgesia or standard analgesia alone. Both groups will be managed and evaluated under the same perioperative protocol, and outcomes will be assessed by blinded observers.
| Arm | Type | Receives |
|---|---|---|
| SPSIPB Group | Experimental | Procedure: Serratus Posterior Superior Intercostal Plane Block (SPSIPB)Patients in this group will receive ultrasound-guided Serratus Posterior Superior Intercostal Plane Block (SPSIPB) with 30 mL of 0.25% bupivacaine in addition to standard anesthesia and analgesia. |
| Sham Block Group | Sham comparator | Procedure: Sham Serratus Posterior Superior Intercostal Plane BlockPatients in this group will undergo the same ultrasound-guided block procedure using identical technique and needle placement, but 30 mL of normal saline will be injected instead of local anesthetic. All other anesthesia and analgesia protocols will be identical to the experimental group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients scheduled for elective minimally invasive cardiac surgery (MICS)
- Age between 18 and 75 years
- American Society of Anesthesiologists (ASA) physical status II-III
- Body mass index (BMI) between 18 and 35 kg/m²
- Patients who provide written informed consent for participation
Key exclusion criteria (10 listed)
- Known allergy or hypersensitivity to local anesthetics
- Coagulopathy or current anticoagulant therapy
- Pregnancy or breastfeeding
- Impaired consciousness or inability to communicate
- Failed or technically inadequate block
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 Block (SPSIPB)The SPSIPB will be performed under ultrasound guidance using an in-plane technique. The needle will be advanced into the fascial plane between the serratus posterior superior and intercostal muscles at the 2nd-3rd intercostal level, and 30 mL of 0.25% bupivacaine will be injected unilaterally on the surgical side. This procedure will be applied in addition to standard anesthesia and analgesia. | Procedure or surgery | SPSIPB Group |
| Sham Serratus Posterior Superior Intercostal Plane BlockThe same ultrasound-guided procedure will be performed using identical technique and needle placement, but 30 mL of normal saline will be injected instead of local anesthetic. This sham block will be performed to maintain blinding, while all other anesthesia and analgesia protocols will be identical to the experimental group. | Procedure or surgery | Sham Block Group |
Primary outcome
Total opioid consumption within 24 hours after surgery
Time frame: 24 hours postoperatively
The total amount of opioids (converted to intravenous morphine equivalent, mg) administered during the first 24 postoperative hours will be recorded from the patient-controlled analgesia (PCA) device and rescue analgesic doses.
7 secondary outcomes
Postoperative pain scores (NRS)
Time frame: 6, 12, and 24 hours postoperatively
Extubation time
Time frame: Immediate postoperative period
Intraoperative opioid consumption
Time frame: During surgery
Block-related complications
Time frame: Within 24 hours postoperatively
Postoperative recovery parameters
Time frame: Within 48 hours postoperatively
Quality of Recovery (QoR-15) score
Time frame: 24 and 48 hours postoperatively
Modified Radiological Atelectasis Score
Time frame: 24 and 48 hours postoperatively
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 24 Apr 2026.
- Background: PubMed 39101308Turan EI, Isik S, Baydemir AE, Sahin AS. Serratus posterior superior intercostal plane block for postoperative analgesia in clavicle surgeries: new indications for a novel block. Minerva Anestesiol. 2024 Nov;90(11):1058-1060. doi: 10.23736/S0375-9393.24.18275-2. Epub 2024 Aug 5. No abstract available.
- Background: PubMed 38343684Avci O, Gundogdu O, Balci F, Tekcan MN, Ozbey M. Efficacy of serratus posterior superior intercostal plane block (SPSIPB) on post-operative pain and total analgesic consumption in patients undergoing video-assisted thoracoscopic surgery (VATS): A double-blinded randomised controlled trial. Indian J Anaesth. 2023 Dec;67(12):1116-1122. doi: 10.4103/ija.ija_589_23. Epub 2023 Dec 13.
- Background: PubMed 39600439Shimizu C, Wakimoto M, Kita T. Efficacy of epidural anesthesia in minimally invasive cardiac surgery. Saudi J Anaesth. 2024 Oct-Dec;18(4):528-533. doi: 10.4103/sja.sja_334_24. Epub 2024 Oct 2.
- Background: PubMed 40272720Dost B, Turunc E, Aydin ME, Kaya C, Aykut A, Demir ZA, Narayanan M, De Cassai A. Pain Management in Minimally Invasive Cardiac Surgery: A Review of Current Clinical Evidence. Pain Ther. 2025 Jun;14(3):913-930. doi: 10.1007/s40122-025-00739-1. Epub 2025 Apr 24.
- Background: PubMed 38999504Piekarski F, Rohner M, Monsefi N, Bakhtiary F, Velten M. Anesthesia for Minimal Invasive Cardiac Surgery: The Bonn Heart Center Protocol. J Clin Med. 2024 Jul 5;13(13):3939. doi: 10.3390/jcm13133939.
- Individual participant dataSharing planned: No. This is a single-center academic study. Individual participant data will not be shared publicly. Aggregate results will be reported in publication.
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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.
Zeliha A Demir, M.D. principal investigator
Ankara Bilkent City Hospital, Department of Anesthesiology and Reanimation, Professor of Aneshesiology
Aslıhan Aykut, M.D. study director
Ankara Bilkent City Hospital, Department of Anesthesiology and Reanimation, Associate Professor of Anesthesiology
Nisan Özsan, M.D. study chair
Ankara Bilkent City Hospital, Department of Anesthesiology and Reanimation
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 (SPSIPB) in people with Heart Valvular Disease and Minimally Invasive Cardiac Surgery, 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 5 inclusion and 10 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 24 Apr 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. Some participants in this study may receive a placebo. 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?
Total opioid consumption within 24 hours after surgery (time frame: 24 hours postoperatively). 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 NCT07259824, which also lists 5 linked publications.
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 24 Apr 2026.