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Postoperative PainNCT07452627

Comparison of the Efficacy of Combined Transversus Thoracic Plane Block and Serratus Anterior Plane Block Versus Erector Spinae Plane Block in the Management of Sternotomy Pain

A study testing TTP Block, ESP Block and SAP Block in people with Postoperative Pain and Sternotomy, run by Uludag University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Background and Purpose: Median sternotomy is the standard surgical approach for cardiac procedures, yet it is associated with significant postoperative pain. Inadequate pain management can lead to pulmonary complications and chronic pain syndromes. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Postoperative Pain, Sternotomy, Nerve Block
What is being tested?
TTP Block, ESP Block and SAP Block
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
1 Dec 2025to Dec 2026
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 between 18 and 80 years.
  • Patients with American Society of Anesthesiologists (ASA) physical status I, II, or III.
  • Patients who provide written informed consent.
  • Patients scheduled for cardiac surgery via elective sternotomy.

Who cannot join

  • Pregnancy or suspected pregnancy
  • Body Mass Index (BMI) > 35 kg/m²
  • History of allergy to local anesthetics or opioids
  • Suspected coagulopathy or infection at the injection site
  • Severe neurological, psychiatric, hepatic, or renal failure

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, 1 recruiting
  • Bursa Uludag University Hospital

    Bursa, Nilüfer, 16235

    Ali Haydar Colak, MD, +90 506 560 35 17 ext. +902242954476, alihaydarcolak@uludag.edu.tr

    Onur Alp, MD, +90 539 956 55 11 ext. +902242953131, onuralp@uludag.edu.tr

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: STERNOTOMİ AĞRISININ YÖNETİMİNDE TRANSVERSUS TORASİK PLAN BLOK VE SERRATUS ANTERİOR PLAN BLOK KOMBİNASYONU İLE EREKTÖR SPİNA PLAN BLOK ETKİNLİĞİNİN KARŞILAŞTIRILMASI

Background and Purpose: Median sternotomy is the standard surgical approach for cardiac procedures, yet it is associated with significant postoperative pain. Inadequate pain management can lead to pulmonary complications and chronic pain syndromes. While opioids are a cornerstone of multimodal analgesia, their side effects-such as sedation, respiratory depression, and nausea-can delay recovery. Furthermore, neuraxial techniques like epidural analgesia are often avoided in cardiac surgery due to the risks associated with systemic heparinization. This study aims to compare the efficacy of two non-neuraxial regional anesthesia techniques: the combination of Transversus Thoracic Plane Block (TTPB) and Serratus Anterior Plane Block (SAPB) versus the Erector Spinae Plane Block (ESPB).

Study Design and Population: This prospective, randomized study includes 50 patients (ASA I-III, aged 18-80) undergoing elective cardiac surgery via median sternotomy. Patients are randomized into two groups:

Read more

TTPB + SAPB Group: Patients receive ultrasound-guided blocks targeting the anterior and lateral chest wall.

ESPB Group: Patients receive ultrasound-guided blocks targeting the paravertebral and intercostal spaces from a posterior approach.

Intervention and Procedures: Following standardized anesthesia induction and invasive monitoring, the respective blocks are performed under ultrasound guidance. Intraoperative hemodynamic data are recorded at key surgical stages (incision, sternotomy, CPB). In the postoperative period in the intensive care unit (ICU), all patients will receive a standardized multimodal analgesia protocol including intravenous (IV) paracetamol and IV tenoxicam. While patients are intubated, pain will be assessed using the Behavioral Pain Scale (BPS). If the BPS score is above 3, IV fentanyl will be administered as rescue analgesia.

Following extubation, pain levels will be evaluated using the Visual Analog Scale (VAS) at rest and during coughing at specific time points (0, 1, 2, 4, 8, 12, 16, and 24 hours). If the post-extubation VAS score is 4 or higher, intramuscular meperidine will be given as rescue analgesia. Additionally, IV ondansetron will be administered in case of nausea or vomiting. The study will also evaluate the time to extubation, time to clinical transport, and patient/surgeon satisfaction using a 5-point Likert scale.

Primary and Secondary Outcomes:

The primary objective of this study is to compare postoperative pain intensity between the study groups using the Visual Analog Scale (VAS) (0-10) and the Behavioral Pain Scale (BPS) (3-12).

Secondary objectives include:

Opioid Consumption: Comparison of total intraoperative and postoperative opioid (IV fentanyl and IM meperidine) consumption within the first 24 hours.

Recovery Milestones: Measurement of time to extubation, time to first mobilization, and time to clinical transport to the surgical ward.

Clinical Satisfaction and Safety: Assessment of patient and surgeon satisfaction using a 5-point Likert scale, and monitoring the incidence of opioid-related side effects, specifically postoperative nausea and vomiting (PONV) requiring ondansetron.

Expected Impact:

By identifying the most effective regional anesthesia technique (TTPB+SAPB vs. ESPB) in conjunction with a standardized multimodal analgesia protocol (IV paracetamol and tenoxicam), this study seeks to maximize postoperative pain control and patient comfort. The results aim to achieve superior analgesia with lower pain scores, thereby facilitating earlier mobilization, reducing the incidence of postoperative complications, and enhancing the overall recovery process for patients undergoing cardiac surgery via median sternotomy. This approach ultimately contributes to the development of more effective, pain-centered recovery protocols in the intensive care unit.

Read the detailed description

Following informed consent, patients will be randomly assigned to either Group TTPB+SAPB or Group ESPB in a 1:1 ratio using a computer-generated sequence to ensure allocation concealment. This is a prospective, observer-blinded trial. While the anesthesiologist performing the blocks is aware of group assignments, the investigators responsible for postoperative data collection will be blinded to the intervention to minimize bias.

Standardized Anesthesia Management All patients will receive a standardized anesthetic protocol. Premedication with IV midazolam will be followed by standard monitoring including ECG, SpO2, and invasive arterial pressure. General anesthesia will be induced with propofol, fentanyl, and rocuronium, and maintained with sevoflurane in an oxygen-air mixture. The Bispectral Index (BIS) will be monitored to maintain a target range between 40 and 60.

Regional Anesthesia Interventions

Blocks will be performed under ultrasound guidance after induction but before surgical incision:

Group TTPB + SAPB: Transversus Thoracic Plane Block will be performed at the T4-T5 level between the internal intercostal and transversus thoracis muscles. Serratus Anterior Plane Block will be performed over the 5th rib in the mid-axillary line targeting the lateral cutaneous branches.

Group ESPB: The T4 transverse process will be identified, and local anesthetic will be injected into the plane between the erector spinae muscle and the transverse process tip to allow for cranio-caudal spread.

Intraoperative and Postoperative Analgesia Protocol Intraoperative hemodynamic parameters will be recorded at key stages (baseline, incision, sternotomy, CPB). If heart rate or MAP increases by >20% from baseline, a rescue bolus of fentanyl will be administered. Postoperatively, all patients will receive a multimodal analgesia regimen consisting of IV paracetamol and IV tenoxicam. Rescue analgesia will be provided based on pain scale assessments as defined in the protocol.

Statistical Analysis Sample size calculation was performed to achieve 80% power with a 5% significance level, requiring a total of 50 patients to account for potential dropouts. Continuous variables will be compared using the Student's t-test or Mann-Whitney U test, while categorical variables will be analyzed using the Chi-square or Fisher's exact test.

Being tested
TTP Block, ESP Block, SAP Block
Keywords
Transversus Thoracic Plane Block, Serratus Anterior Plane Block, Erector Spinae Plane Block, Sternotomy Pain, Cardiac Surgery, Multimodal 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.

  • TTP BlockProcedure or surgery

    A combination of Transversus Thoracic Plane Block (TTPB) at the T4-T5 level will be performed using 0.25% bupivacaine (0.5 mg/kg)

  • ESP BlockProcedure or surgery

    Erector Spinae Plane Block (ESPB) at the T4 transverse process level will be performed using 0.25% bupivacaine (0.5 mg/kg)

  • SAP BlockProcedure or surgery

    Serratus Anterior Plane Block (SAPB) at the 5th rib level will be performed using 0.25% bupivacaine (0.5 mg/kg)

Study groups in NCT07452627
Study groupRoleWhat they receive
TTPB+ SAPB GroupExperimentalPatients in this group will receive a combination of Transversus Thoracic Plane Block and Serratus Anterior Plane Block for postoperative analgesia.
Receives: Procedure: TTP Block; Procedure: SAP Block
ESPB GroupExperimentalPatients in this group will receive Erector Spinae Plane Block for postoperative analgesia.
Receives: Procedure: ESP Block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative Pain Intensity

    Pain will be assessed using the Visual Analog Scale (VAS) (0 = no pain, 10 = worst possible pain) during rest and coughing at the 0th minute, and 1st, 2nd, 4th, 8th, 12th, 16th, and 24th hours post-extubation.

    Measured: Up to 24 hours post-extubation.

Secondary outcomes (6)
  1. Behavioral Pain Scale (BPS) Scores

    Assessment of pain in intubated patients (Score range: 3-12). Higher scores indicate more pain.

    Measured: From admission to ICU until extubation (approx. 6-12 hours).

  2. Total Rescue Analgesic Consumption

    The total amount (mg) of intravenous Fentanyl and intramuscular Meperidine administered as rescue analgesics.

    Measured: Up to 24 hours post-operation.

  3. Time to Extubation

    The duration from the end of surgery until the patient meets extubation criteria and is extubated.

    Measured: From the end of surgery up to 12 hours.

  4. Time to Transport to Ward

    The duration from ICU admission until the patient is stable enough to be transferred to the surgical ward.

    Measured: Up to 48 hours.

  5. Patient Satisfaction Score

    Evaluated using a 5-point Likert Scale (1 = very dissatisfied, 5 = very satisfied).

    Measured: At the 24th hour post-operation.

  6. Surgeon Satisfaction Score

    The primary surgeon's satisfaction with the analgesia quality and ease of the procedure, evaluated using a 5-point Likert scale (1=Very Dissatisfied, 5=Very Satisfied).

    Measured: Up to 24 hours postoperatively.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2026
  2. Study start1 Dec 2025
  3. Primary completion1 Nov 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07452627
Sponsor's protocol ID
25-AKD-310
Status last verified
Feb 2026
First submitted
28 Feb 2026
Last updated
10 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: "The individual participant data (IPD) will not be shared to protect patient privacy and confidentiality. The data collected for this study will only be used for the purposes of this specific research and will not be made available to other researchers to comply with institutional ethical guidelines."

Publications

  • Dost B, De Cassai A, Balzani E, Tulgar S, Ahiskalioglu A. Effects of ultrasound-guided regional anesthesia in cardiac surgery: a systematic review and network meta-analysis. BMC Anesthesiol. 2022 Dec 29;22(1):409. doi: 10.1186/s12871-022-01952-7.

    PubMed 36581838
  • Nagaraja PS, Ragavendran S, Singh NG, Asai O, Bhavya G, Manjunath N, Rajesh K. Comparison of continuous thoracic epidural analgesia with bilateral erector spinae plane block for perioperative pain management in cardiac surgery. Ann Card Anaesth. 2018 Jul-Sep;21(3):323-327. doi: 10.4103/aca.ACA_16_18.

    PubMed 30052229
  • Mansour MA, Mahmoud HE, Fakhry DM, Kassim DY. Comparison of the effects of transversus thoracic muscle plane block and pecto-intercostal fascial block on postoperative opioid consumption in patients undergoing open cardiac surgery: a prospective randomized study. BMC Anesthesiol. 2024 Feb 10;24(1):63. doi: 10.1186/s12871-024-02432-w.

    PubMed 38341525

Questions about this trial

What is this clinical trial studying?

A study testing TTP Block, ESP Block and SAP Block in people with Postoperative Pain and Sternotomy, run by Uludag University 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 5 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: looking for participants now, as of the sponsor's last update on 10 Mar 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative Pain Intensity (time frame: Up to 24 hours post-extubation.). 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 NCT07452627, which also lists 3 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 10 Mar 2026.

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