Postoperative PainHanedan BlockNCT07522229
Parasternal vs. Combined Parasternal-Serratus Block in Cardiac Surgery
A study testing Parasternal Intercostal Plane Block and Parasternal Intercostal Plane Block + Serratus Anterior Plane Block in people with Postoperative Pain and Cardiac Surgery, run by BEDİA MİNE HANEDAN at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to compare the analgesic efficacy of parasternal intercostal plane block (PIPB) alone versus the combination of parasternal intercostal plane block and serratus anterior plane block (SAPB) in adult patients undergoing elective cardiac surgery via sternotomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Cardiac Surgery
- What is being tested?
- Parasternal Intercostal Plane Block and Parasternal Intercostal Plane Block + Serratus Anterior 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
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Oct 2025to 5 May 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
- Inclusion Criteria Adult patients aged 18 years or older Patients scheduled for elective cardiac surgery Patients admitted postoperatively to the intensive care unit Patients who provide written informed consent
- Exclusion Criteria Known allergy to study medications Chronic opioid use before surgery Severe hepatic or renal failure Neurological or psychiatric disorders affecting pain assessment Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Analgesic Effects of Parasternal Intercostal Plane Block Versus Combined Parasternal and Serratus Plane Block After Cardiac Surgery: A Randomized Controlled Trial
This randomized controlled trial aims to compare the analgesic efficacy of parasternal intercostal plane block (PIPB) alone versus the combination of parasternal intercostal plane block and serratus anterior plane block (SAPB) in adult patients undergoing elective cardiac surgery via sternotomy. Seventy patients will be randomly assigned to two groups: Group A will receive bilateral PIPB, while Group B will receive bilateral PIPB combined with unilateral SAPB on the side of chest drain placement. Postoperative pain will be assessed using the visual analog scale (VAS) at rest and during movement over the first 24 hours. Secondary outcomes include time to extubation, length of stay in the intensive care unit, and time to mobilization. The study is designed as a prospective, single-center, single-blind trial conducted at Akdeniz University Hospital, Antalya, Turkey. We hypothesize that the combined block technique will provide superior analgesia, reduce opioid consumption, and improve recovery parameters compared to PIPB alone
Read the detailed description
Poststernotomy pain after cardiac surgery is a major clinical concern, often leading to impaired respiratory function, limited mobilization, and prolonged intensive care unit (ICU) stay. Although opioids are traditionally used as the mainstay of postoperative analgesia, their side effects-including respiratory depression, nausea, constipation, and delirium-limit their optimal use. Therefore, regional anesthesia techniques that reduce opioid consumption have gained increasing importance in cardiac anesthesia practice.
The parasternal intercostal plane block (PIPB) targets the anterior branches of the thoracic intercostal nerves and has been shown to provide effective analgesia around the sternotomy site. However, PIPB alone may be insufficient for controlling pain originating from lateral chest wall regions, particularly at chest drain insertion sites, which are innervated by the lateral cutaneous branches of the intercostal nerves. To address this limitation, the serratus anterior plane block (SAPB) has been proposed, as it effectively blocks the lateral thoracic dermatomes and thus may provide broader postoperative pain coverage.
This prospective, randomized, single-blind clinical trial is designed to compare the analgesic efficacy of bilateral PIPB alone versus bilateral PIPB combined with unilateral SAPB in adult patients undergoing elective cardiac surgery via sternotomy. A total of 70 patients will be randomly allocated into two groups: Group A will receive bilateral PIPB with standard intravenous morphine, while Group B will receive bilateral PIPB plus unilateral SAPB on the side of chest drain placement. Blocks will be performed under ultrasound guidance using bupivacaine at safe dose limits.
The primary outcome is postoperative pain intensity assessed by the visual analog scale (VAS) at rest and during coughing/movement within the first 24 hours. Secondary outcomes include time to extubation, ICU length of stay, and time to first mobilization. Additional endpoints are rescue opioid requirements and total analgesic consumption within the first 24 hours. We hypothesize that the combined PIPB + SAPB technique will provide superior analgesia, reduce opioid use, and enhance recovery parameters compared with PIPB alone.
- Conditions
- Postoperative Pain, Cardiac Surgery
- Being tested
- Parasternal Intercostal Plane Block, Parasternal Intercostal Plane Block + Serratus Anterior Plane Block
- Keywords
- Parasternal Intercostal Plane Block, Serratus Anterior Plane Block, Cardiac Surgery 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.
Parasternal Intercostal Plane BlockProcedure or surgery
Bilateral parasternal intercostal plane block will be performed under ultrasound guidance at the 3rd and 5th intercostal spaces using 0.25% bupivacaine (total 30 mL). At the end of surgery, intravenous morphine (0.1 mg/kg) will be administered.
Parasternal Intercostal Plane Block + Serratus Anterior Plane BlockProcedure or surgery
Bilateral parasternal intercostal plane block will be performed as in Arm 1. In addition, a unilateral serratus anterior plane block will be performed under ultrasound guidance at the 4th-6th intercostal level on the side of chest drain placement, with 0.25% bupivacaine (5-7 mL per injection site, not exceeding 2.5 mg/kg).
| Study group | Role | What they receive |
|---|---|---|
| Parasternal Intercostal Plane Block | Experimental | Patients will receive bilateral parasternal intercostal plane block with bupivacaine under ultrasound guidance, plus standard intravenous morphine at the end of surgery. Receives: Procedure: Parasternal Intercostal Plane Block; Procedure: Parasternal Intercostal Plane Block + Serratus Anterior Plane Block |
| Parasternal + Serratus Plane Block | Experimental | Patients will receive bilateral parasternal intercostal plane block combined with unilateral serratus anterior plane block (on the chest drain side), using bupivacaine under ultrasound guidance. Receives: Procedure: Parasternal Intercostal Plane Block; Procedure: Parasternal Intercostal Plane Block + Serratus Anterior Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain intensity (VAS)
Pain intensity measured using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Measured: 24 hours after surgery
Secondary outcomes (3)
Time to extubation
The duration (in minutes) from the end of surgery to successful extubation.
Measured: Postoperative period until extubation.
Length of stay in the intensive care unit (ICU)
Duration of ICU stay measured from admission to the intensive care unit after surgery until transfer to the hospital ward.
Measured: From ICU admission after surgery until ICU discharge, up to 30 days
Time to first mobilization
Time from admission to the intensive care unit after surgery until the first documented patient mobilization attempt.
Measured: From ICU admission after surgery until the first mobilization attempt, assessed up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start5 Oct 2025
- Primary completion5 May 2026
- Study completion5 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- BEDİA MİNE HANEDAN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, BEDİA MİNE HANEDAN, Konya City Hospital
- Investigators
- BEDİA MİNE HANEDAN, Principal investigator, Konya şehir hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07522229
- Sponsor's protocol ID
- HanedanBlock-01
- Acronym
- Hanedan Block
- Status last verified
- May 2026
- First submitted
- 25 Sep 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators have not yet determined whether individual participant data (IPD) will be shared. If sharing is pursued, de-identified data related to postoperative pain scores, opioid consumption, and recovery parameters may be made available to qualified researchers upon reasonable request after the main results are published.
Publications
Kuwano K, Kawasaki M, Maeyama T, Hagimoto N, Nakamura N, Shirakawa K, Hara N. Soluble form of fas and fas ligand in BAL fluid from patients with pulmonary fibrosis and bronchiolitis obliterans organizing pneumonia. Chest. 2000 Aug;118(2):451-8. doi: 10.1378/chest.118.2.451.
PubMed 10936140Servidio AG, Capata G, Levantino L, Riccio G, Contorno S, Barbi E, Maschio M. COVID-19 lockdown beneficial effects on lung function in a cohort of cystic fibrosis patients. Ital J Pediatr. 2021 Jan 18;47(1):12. doi: 10.1186/s13052-021-00970-4. No abstract available.
PubMed 33461569
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Analgesic Effects of Parasternal Intercostal Plane Block Versus Combined Parasternal and Serratus Plane Block After Cardiac Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07522229
- Acronym / sponsor ID
- Hanedan Block / HanedanBlock-01
- Conditions
- Postoperative Pain, Cardiac Surgery
- Keywords
- Parasternal Intercostal Plane Block, Serratus Anterior Plane Block, Cardiac Surgery Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- BEDİA MİNE HANEDANUniversity, hospital or other
- Study start
- 5 Oct 2025 (actual)
- Primary completion
- 5 May 2026 (actual)
- Study completion
- 5 May 2026 (actual)
- First posted
- 13 Apr 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 randomized controlled trial aims to compare the analgesic efficacy of parasternal intercostal plane block (PIPB) alone versus the combination of parasternal intercostal plane block and serratus anterior plane block (SAPB) in adult patients undergoing elective cardiac surgery via sternotomy. Seventy patients will be randomly assigned to two groups: Group A will receive bilateral PIPB, while Group B will receive bilateral PIPB combined with unilateral SAPB on the side of chest drain placement. Postoperative pain will be assessed using the visual analog scale (VAS) at rest and during movement over the first 24 hours. Secondary outcomes include time to extubation, length of stay in the intensive care unit, and time to mobilization. The study is designed as a prospective, single-center, single-blind trial conducted at Akdeniz University Hospital, Antalya, Turkey. We hypothesize that the combined block technique will provide superior analgesia, reduce opioid consumption, and improve recovery parameters compared to PIPB alone
Detailed description
Poststernotomy pain after cardiac surgery is a major clinical concern, often leading to impaired respiratory function, limited mobilization, and prolonged intensive care unit (ICU) stay. Although opioids are traditionally used as the mainstay of postoperative analgesia, their side effects-including respiratory depression, nausea, constipation, and delirium-limit their optimal use. Therefore, regional anesthesia techniques that reduce opioid consumption have gained increasing importance in cardiac anesthesia practice.
The parasternal intercostal plane block (PIPB) targets the anterior branches of the thoracic intercostal nerves and has been shown to provide effective analgesia around the sternotomy site. However, PIPB alone may be insufficient for controlling pain originating from lateral chest wall regions, particularly at chest drain insertion sites, which are innervated by the lateral cutaneous branches of the intercostal nerves. To address this limitation, the serratus anterior plane block (SAPB) has been proposed, as it effectively blocks the lateral thoracic dermatomes and thus may provide broader postoperative pain coverage.
This prospective, randomized, single-blind clinical trial is designed to compare the analgesic efficacy of bilateral PIPB alone versus bilateral PIPB combined with unilateral SAPB in adult patients undergoing elective cardiac surgery via sternotomy. A total of 70 patients will be randomly allocated into two groups: Group A will receive bilateral PIPB with standard intravenous morphine, while Group B will receive bilateral PIPB plus unilateral SAPB on the side of chest drain placement. Blocks will be performed under ultrasound guidance using bupivacaine at safe dose limits.
The primary outcome is postoperative pain intensity assessed by the visual analog scale (VAS) at rest and during coughing/movement within the first 24 hours. Secondary outcomes include time to extubation, ICU length of stay, and time to first mobilization. Additional endpoints are rescue opioid requirements and total analgesic consumption within the first 24 hours. We hypothesize that the combined PIPB + SAPB technique will provide superior analgesia, reduce opioid use, and enhance recovery parameters compared with PIPB alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parasternal Intercostal Plane Block | Experimental | Procedure: Parasternal Intercostal Plane Block, Procedure: Parasternal Intercostal Plane Block + Serratus Anterior Plane BlockPatients will receive bilateral parasternal intercostal plane block with bupivacaine under ultrasound guidance, plus standard intravenous morphine at the end of surgery. |
| Parasternal + Serratus Plane Block | Experimental | Procedure: Parasternal Intercostal Plane Block, Procedure: Parasternal Intercostal Plane Block + Serratus Anterior Plane BlockPatients will receive bilateral parasternal intercostal plane block combined with unilateral serratus anterior plane block (on the chest drain side), using bupivacaine under ultrasound guidance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Parasternal Intercostal Plane BlockBilateral parasternal intercostal plane block will be performed under ultrasound guidance at the 3rd and 5th intercostal spaces using 0.25% bupivacaine (total 30 mL). At the end of surgery, intravenous morphine (0.1 mg/kg) will be administered. | Procedure or surgery | Parasternal + Serratus Plane Block, Parasternal Intercostal Plane Block |
| Parasternal Intercostal Plane Block + Serratus Anterior Plane BlockBilateral parasternal intercostal plane block will be performed as in Arm 1. In addition, a unilateral serratus anterior plane block will be performed under ultrasound guidance at the 4th-6th intercostal level on the side of chest drain placement, with 0.25% bupivacaine (5-7 mL per injection site, not exceeding 2.5 mg/kg). | Procedure or surgery | Parasternal + Serratus Plane Block, Parasternal Intercostal Plane Block |
Primary outcome
Postoperative pain intensity (VAS)
Time frame: 24 hours after surgery
Pain intensity measured using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
3 secondary outcomes
Time to extubation
Time frame: Postoperative period until extubation.
Length of stay in the intensive care unit (ICU)
Time frame: From ICU admission after surgery until ICU discharge, up to 30 days
Time to first mobilization
Time frame: From ICU admission after surgery until the first mobilization attempt, assessed up to 30 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 6 May 2026.
- Background: PubMed 10936140Kuwano K, Kawasaki M, Maeyama T, Hagimoto N, Nakamura N, Shirakawa K, Hara N. Soluble form of fas and fas ligand in BAL fluid from patients with pulmonary fibrosis and bronchiolitis obliterans organizing pneumonia. Chest. 2000 Aug;118(2):451-8. doi: 10.1378/chest.118.2.451.
- Background: PubMed 33461569Servidio AG, Capata G, Levantino L, Riccio G, Contorno S, Barbi E, Maschio M. COVID-19 lockdown beneficial effects on lung function in a cohort of cystic fibrosis patients. Ital J Pediatr. 2021 Jan 18;47(1):12. doi: 10.1186/s13052-021-00970-4. No abstract available.
- Individual participant dataSharing planned: Yes. The investigators have not yet determined whether individual participant data (IPD) will be shared. If sharing is pursued, de-identified data related to postoperative pain scores, opioid consumption, and recovery parameters may be made available to qualified researchers upon reasonable request after the main results are published.
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
BEDİA MİNE HANEDAN principal investigator
Konya şehir hastanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parasternal Intercostal Plane Block and Parasternal Intercostal Plane Block + Serratus Anterior Plane Block in people with Postoperative Pain and Cardiac Surgery, run by BEDİA MİNE HANEDAN 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?
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 6 May 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?
Postoperative pain intensity (VAS) (time frame: 24 hours after surgery). 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 NCT07522229, which also lists 2 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 6 May 2026.