Postoperative PainNCT07472296
Comparison of Erector Spinae Plane Block (ESPB) With the Combination of Superficial Parasternal Intercostal Plane Block (SPIPB) and Serratus Anterior Plane Block (SAPB) in the Management of Postoperative Sternotomy Pain in Patients Undergoing Cardiac Surgery Via Sternotomy
A study testing Erector spinae plane block (ESPB), Superficial Parasternal Intercostal Plane Block (SPIPB) and Serratus Anterior Plane Block (SAPB) in people with Postoperative Pain and Sternotomy Pain, run by Uludag University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare the effectiveness of two regional anesthesia techniques in managing pain for participants undergoing cardiac surgery via sternotomy. The investigators will evaluate whether the Erector Spinae Plane Block (ESPB) or a combination of the Superficial Parasternal Intercostal Plane Block (SPIPB)… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pain, Sternotomy Pain, Acute Pain
- What is being tested?
- Erector spinae plane block (ESPB), Superficial Parasternal Intercostal Plane Block (SPIPB) and Serratus Anterior Plane Block (SAPB)
- 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 Nov 2025to Nov 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 classified as American Society of Anesthesiologists (ASA) physical status I, II, or III.
- Patients scheduled for elective cardiac surgery via median sternotomy.
- Patients who have provided written informed consent.
Who cannot join
- Pregnancy or suspected pregnancy.
- Body Mass Index (BMI) > 35 kg/m².
- Known allergy or hypersensitivity to local anesthetics (e.g., bupivacaine).
- Suspected coagulopathy or bleeding disorders.
- Infection at the site of the regional block injection.
- Severe hepatic or renal failure.
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- Severe neurological or psychiatric disorders.
- Emergency surgical procedures.
- Re-operation cases (Redo-surgery)
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
- Recruiting
Bursa Uludag University Hospital
Bursa, Nilüfer, 16235
Onur Alp, Medical Doctor, +905399565511 ext. +902242953131, onuralp@uludag.edu.tr
Ali Haydar Colak, Medical Doctor, +905065603517 ext. +902242953131, alihaydarcolak@uludag.edu.tr
About this study
Official title: Sternotomi İle Kardiyak Cerrahi Planlanan Hastalarda Postoperatif Sternotomi Ağrısının Yönetiminde Erektör Spina Plan Blok (ESPB) Ile Yüzeyel Parasternal İnterkostal Plan Bloğu (SPIPB) ve Serratus Anterior Plan Bloğu (SAPB) Kombinasyonunun Karşılaştırılması
This study aims to compare the effectiveness of two regional anesthesia techniques in managing pain for participants undergoing cardiac surgery via sternotomy. The investigators will evaluate whether the Erector Spinae Plane Block (ESPB) or a combination of the Superficial Parasternal Intercostal Plane Block (SPIPB) and Serratus Anterior Plane Block (SAPB) provides better pain control and recovery outcomes.
Read the detailed description
The investigators aim to compare the effects of the erector spinae plane block (ESPB) versus the combination of superficial parasternal intercostal plane block (SPIPB) and serratus anterior plane block (SAPB) in the management of postoperative sternotomy pain among participants scheduled for cardiac surgery via sternotomy.
Study design and methods: A total of 50 participants (aged 18-80, ASA I-III) scheduled for sternotomy will be randomly assigned to one of two groups:
ESPB Group: Participants receive the Erector Spinae Plane Block. SPIPB + SAPB Group: Participants receive a combination of both blocks. Prior to the induction of general anesthesia, participants are randomized into two groups: the ESPB group and the SPIPB + SAPB group. Nerve blocks are performed in both groups. Visual Analog Scale (VAS) scores at rest and during coughing, intraoperative opioid consumption, postoperative behavioral pain scores, extubation times, and time to the first rescue analgesic requirement are evaluated.
- Being tested
- Erector spinae plane block (ESPB), Superficial Parasternal Intercostal Plane Block (SPIPB), Serratus Anterior Plane Block (SAPB)
- Keywords
- Erector Spinae Plane Block, Serratus Anterior Plane Block, Superficial Parasternal Intercostal Plane Block, Opioid Consumption, Multimodal Analgesia
- Medical subject headings
- Pain, Postoperative, Acute Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinae plane block (ESPB)Procedure or surgery
Bilateral ultrasound-guided ESPB is performed at the T4 or T5 vertebral level. Following skin preparation and visualization of the transverse process and erector spinae muscle, a block needle is inserted. After confirming the needle tip position between the muscle and the transverse process, 0.5 mL/kg of 0.25% Bupivacaine is injected on each side.
Superficial Parasternal Intercostal Plane Block (SPIPB)Procedure or surgery
Bilateral ultrasound-guided SPIPB is performed. 0.25% Bupivacaine is administered. This is part of a combined regional analgesia technique for sternotomy.
Serratus Anterior Plane Block (SAPB)Procedure or surgery
Bilateral ultrasound-guided SAPB is performed. 0.25% Bupivacaine is administered. This is part of a combined regional analgesia technique for the chest wall.
| Study group | Role | What they receive |
|---|---|---|
| Erector Spinae Plane Block Group | Active comparator | Participants in this group will receive a bilateral ultrasound-guided Erector Spinae Plane Block (ESPB) for postoperative analgesia. Receives: Procedure: Erector spinae plane block (ESPB) |
| SPIPB and SAPB Group | Active comparator | Participants in this group will receive a combination of bilateral ultrasound-guided Superficial Parasternal Intercostal Plane Block (SPIPB) and Serratus Anterior Plane Block (SAPB) for postoperative analgesia. Receives: Procedure: Superficial Parasternal Intercostal Plane Block (SPIPB); Procedure: Serratus Anterior Plane Block (SAPB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity (Visual Analog Scale Score)
Pain levels assessed using the Visual Analog Scale (0 = no pain, 10 = worst imaginable pain).
Measured: At 0, 1, 2, 4, 8, 12, 16 and 24 hours postoperatively.
Secondary outcomes (4)
Extubation Time
The duration from the end of the surgical procedure until the patient is successfully extubated.
Measured: From the end of surgery until the date of successful endotracheal tube removal, assessed up to 24 hours.
Total Postoperative Opioid Consumption
Total amount of opioid (e.g., morphine or fentanyl) administered to the patient in the first 24 hours.
Measured: From the end of surgery up to 24 hours postoperatively.
Behavioral Pain Scale (BPS)
Pain assessment based on facial expression, upper limb movement, and compliance with ventilation.
Measured: From ICU admission until extubation, assessed up to 24 hours.
Time to First Rescue Analgesic
The time elapsed from the end of surgery until the patient first requires additional pain medication.
Measured: From the end of surgery until the first dose of rescue analgesic, assessed up to 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 Nov 2025
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
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 Postoperative 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Onur Alp, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07472296
- Sponsor's protocol ID
- 25-AKD-251
- Status last verified
- Feb 2026
- First submitted
- 5 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators do not plan to share individual participant data to protect patient privacy and comply with institutional data protection regulations.
Publications
Yadav S, Raman R, Prabha R, Kaushal D, Yadav P, Kumar S. Randomized Controlled Trial of Ultrasound-Guided Parasternal Intercostal Nerve Block and Transversus Thoracis Muscle Plane Block for Postoperative Analgesia of Cardiac Surgical Patients. Cureus. 2024 Oct 23;16(10):e72174. doi: 10.7759/cureus.72174. eCollection 2024 Oct.
PubMed 39583527Zou M, Ruan W, Liu J, Xu J. Preemptive parasternal intercostal nerve block for patients undergoing off-pump coronary artery bypass grafting: a double-blind, randomized, controlled trial. Front Cardiovasc Med. 2023 May 18;10:1188518. doi: 10.3389/fcvm.2023.1188518. eCollection 2023.
PubMed 37273884Balan C, Boros C, Morosanu B, Coman A, Stanculea I, Valeanu L, Sefan M, Pavel B, Ioan AM, Wong A, Bubenek-Turconi SI. Nociception level index-directed superficial parasternal intercostal plane block vs erector spinae plane block in open-heart surgery: a propensity matched non-inferiority clinical trial. J Clin Monit Comput. 2025 Feb;39(1):59-72. doi: 10.1007/s10877-024-01236-0. Epub 2024 Oct 29.
PubMed 39470954Bousquet P, Labaste F, Gobin J, Marcheix B, Minville V. Bilateral Parasternal Block and Bilateral Erector Spinae Plane Block Reduce Opioid Consumption in During Cardiac Surgery. J Cardiothorac Vasc Anesth. 2021 Apr;35(4):1249-1250. doi: 10.1053/j.jvca.2020.07.021. Epub 2020 Jul 9. No abstract available.
PubMed 32843270Dost B, Kaya C, Turunc E, Dokmeci H, Yucel SM, Karakaya D. Erector spinae plane block versus its combination with superficial parasternal intercostal plane block for postoperative pain after cardiac surgery: a prospective, randomized, double-blind study. BMC Anesthesiol. 2022 Sep 16;22(1):295. doi: 10.1186/s12871-022-01832-0.
PubMed 36114466
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sternotomi İle Kardiyak Cerrahi Planlanan Hastalarda Postoperatif Sternotomi Ağrısının Yönetiminde Erektör Spina Plan Blok (ESPB) Ile Yüzeyel Parasternal İnterkostal Plan Bloğu (SPIPB) ve Serratus Anterior Plan Bloğu (SAPB) Kombinasyonunun Karşılaştırılması
- ClinicalTrials.gov ID
- NCT07472296
- Acronym / sponsor ID
- 25-AKD-251
- Keywords
- Erector Spinae Plane Block, Serratus Anterior Plane Block, Superficial Parasternal Intercostal Plane Block, Opioid Consumption, Multimodal Analgesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 16 Mar 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 study aims to compare the effectiveness of two regional anesthesia techniques in managing pain for participants undergoing cardiac surgery via sternotomy. The investigators will evaluate whether the Erector Spinae Plane Block (ESPB) or a combination of the Superficial Parasternal Intercostal Plane Block (SPIPB) and Serratus Anterior Plane Block (SAPB) provides better pain control and recovery outcomes.
Detailed description
The investigators aim to compare the effects of the erector spinae plane block (ESPB) versus the combination of superficial parasternal intercostal plane block (SPIPB) and serratus anterior plane block (SAPB) in the management of postoperative sternotomy pain among participants scheduled for cardiac surgery via sternotomy.
Study design and methods: A total of 50 participants (aged 18-80, ASA I-III) scheduled for sternotomy will be randomly assigned to one of two groups:
ESPB Group: Participants receive the Erector Spinae Plane Block. SPIPB + SAPB Group: Participants receive a combination of both blocks. Prior to the induction of general anesthesia, participants are randomized into two groups: the ESPB group and the SPIPB + SAPB group. Nerve blocks are performed in both groups. Visual Analog Scale (VAS) scores at rest and during coughing, intraoperative opioid consumption, postoperative behavioral pain scores, extubation times, and time to the first rescue analgesic requirement are evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae Plane Block Group | Active comparator | Procedure: Erector spinae plane block (ESPB)Participants in this group will receive a bilateral ultrasound-guided Erector Spinae Plane Block (ESPB) for postoperative analgesia. |
| SPIPB and SAPB Group | Active comparator | Procedure: Superficial Parasternal Intercostal Plane Block (SPIPB), Procedure: Serratus Anterior Plane Block (SAPB)Participants in this group will receive a combination of bilateral ultrasound-guided Superficial Parasternal Intercostal Plane Block (SPIPB) and Serratus Anterior Plane Block (SAPB) for postoperative analgesia. |
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 between 18 and 80 years.
- Patients classified as American Society of Anesthesiologists (ASA) physical status I, II, or III.
- Patients scheduled for elective cardiac surgery via median sternotomy.
- Patients who have provided written informed consent.
Key exclusion criteria (9 listed)
- Pregnancy or suspected pregnancy.
- Body Mass Index (BMI) > 35 kg/m².
- Known allergy or hypersensitivity to local anesthetics (e.g., bupivacaine).
- Suspected coagulopathy or bleeding disorders.
- Infection at the site of the regional block injection.
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 |
|---|---|---|
| Erector spinae plane block (ESPB)Bilateral ultrasound-guided ESPB is performed at the T4 or T5 vertebral level. Following skin preparation and visualization of the transverse process and erector spinae muscle, a block needle is inserted. After confirming the needle tip position between the muscle and the transverse process, 0.5 mL/kg of 0.25% Bupivacaine is injected on each side. | Procedure or surgery | Erector Spinae Plane Block Group |
| Superficial Parasternal Intercostal Plane Block (SPIPB)Bilateral ultrasound-guided SPIPB is performed. 0.25% Bupivacaine is administered. This is part of a combined regional analgesia technique for sternotomy. | Procedure or surgery | SPIPB and SAPB Group |
| Serratus Anterior Plane Block (SAPB)Bilateral ultrasound-guided SAPB is performed. 0.25% Bupivacaine is administered. This is part of a combined regional analgesia technique for the chest wall. | Procedure or surgery | SPIPB and SAPB Group |
Primary outcome
Pain Intensity (Visual Analog Scale Score)
Time frame: At 0, 1, 2, 4, 8, 12, 16 and 24 hours postoperatively.
Pain levels assessed using the Visual Analog Scale (0 = no pain, 10 = worst imaginable pain).
4 secondary outcomes
Extubation Time
Time frame: From the end of surgery until the date of successful endotracheal tube removal, assessed up to 24 hours.
Total Postoperative Opioid Consumption
Time frame: From the end of surgery up to 24 hours postoperatively.
Behavioral Pain Scale (BPS)
Time frame: From ICU admission until extubation, assessed up to 24 hours.
Time to First Rescue Analgesic
Time frame: From the end of surgery until the first dose of rescue analgesic, assessed up to 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 16 Mar 2026.
- Background: PubMed 39583527Yadav S, Raman R, Prabha R, Kaushal D, Yadav P, Kumar S. Randomized Controlled Trial of Ultrasound-Guided Parasternal Intercostal Nerve Block and Transversus Thoracis Muscle Plane Block for Postoperative Analgesia of Cardiac Surgical Patients. Cureus. 2024 Oct 23;16(10):e72174. doi: 10.7759/cureus.72174. eCollection 2024 Oct.
- Background: PubMed 37273884Zou M, Ruan W, Liu J, Xu J. Preemptive parasternal intercostal nerve block for patients undergoing off-pump coronary artery bypass grafting: a double-blind, randomized, controlled trial. Front Cardiovasc Med. 2023 May 18;10:1188518. doi: 10.3389/fcvm.2023.1188518. eCollection 2023.
- Background: PubMed 39470954Balan C, Boros C, Morosanu B, Coman A, Stanculea I, Valeanu L, Sefan M, Pavel B, Ioan AM, Wong A, Bubenek-Turconi SI. Nociception level index-directed superficial parasternal intercostal plane block vs erector spinae plane block in open-heart surgery: a propensity matched non-inferiority clinical trial. J Clin Monit Comput. 2025 Feb;39(1):59-72. doi: 10.1007/s10877-024-01236-0. Epub 2024 Oct 29.
- Background: PubMed 32843270Bousquet P, Labaste F, Gobin J, Marcheix B, Minville V. Bilateral Parasternal Block and Bilateral Erector Spinae Plane Block Reduce Opioid Consumption in During Cardiac Surgery. J Cardiothorac Vasc Anesth. 2021 Apr;35(4):1249-1250. doi: 10.1053/j.jvca.2020.07.021. Epub 2020 Jul 9. No abstract available.
- Background: PubMed 36114466Dost B, Kaya C, Turunc E, Dokmeci H, Yucel SM, Karakaya D. Erector spinae plane block versus its combination with superficial parasternal intercostal plane block for postoperative pain after cardiac surgery: a prospective, randomized, double-blind study. BMC Anesthesiol. 2022 Sep 16;22(1):295. doi: 10.1186/s12871-022-01832-0.
- Individual participant dataSharing planned: No. The investigators do not plan to share individual participant data to protect patient privacy and comply with institutional data protection regulations.
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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 Erector spinae plane block (ESPB), Superficial Parasternal Intercostal Plane Block (SPIPB) and Serratus Anterior Plane Block (SAPB) in people with Postoperative Pain and Sternotomy Pain, 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 9 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 16 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?
Pain Intensity (Visual Analog Scale Score) (time frame: At 0, 1, 2, 4, 8, 12, 16 and 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 NCT07472296, 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 16 Mar 2026.