- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07522229
Parasternal vs. Combined Parasternal-Serratus Block in Cardiac Surgery (Hanedan Block)
Comparison of the Analgesic Effects of Parasternal Intercostal Plane Block Versus Combined Parasternal and Serratus Plane Block After Cardiac Surgery: A Randomized Controlled Trial
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Konya, Turkey (Türkiye)
- SBÜ Konya Şehir Hastanesi
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Parasternal Intercostal Plane Block
Patients will receive bilateral parasternal intercostal plane block with bupivacaine under ultrasound guidance, plus standard intravenous morphine at the end of surgery.
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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.
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).
|
|
Experimental: Parasternal + Serratus Plane Block
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.
|
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.
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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24 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to extubation
Time Frame: Postoperative period until extubation.
|
The duration (in minutes) from the end of surgery to successful extubation.
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Postoperative period until extubation.
|
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Length of stay in the intensive care unit (ICU)
Time Frame: From ICU admission after surgery until ICU discharge, up to 30 days
|
Duration of ICU stay measured from admission to the intensive care unit after surgery until transfer to the hospital ward.
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From ICU admission after surgery until ICU discharge, up to 30 days
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Time to first mobilization
Time Frame: From ICU admission after surgery until the first mobilization attempt, assessed up to 30 days
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Time from admission to the intensive care unit after surgery until the first documented patient mobilization attempt.
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From ICU admission after surgery until the first mobilization attempt, assessed up to 30 days
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of rescue opioid administrations
Time Frame: Within the first 24 hours after surgery
|
Total number of rescue opioid administrations required for postoperative analgesia.
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Within the first 24 hours after surgery
|
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Total dose of rescue opioids
Time Frame: Within the first 24 hours after surgery
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Total cumulative dose of rescue opioids administered for postoperative analgesia.
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Within the first 24 hours after surgery
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: BEDİA MİNE HANEDAN, Konya şehir hastanesi
Publications and helpful links
General 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.
- Servidio 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HanedanBlock-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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