- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07299760
Analgesic Efficacy of Parasternal Block Versus Parasternal Plus Serratus Anterior Plane Block After Coronary Bypass Surgery
Evaluation of the Analgesic Efficacy of Parasternal Block and Parasternal Plus Serratus Anterior Plane Block in Patients Undergoing Coronary Artery Bypass Grafting Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: Postoperative pain after coronary artery bypass surgery arises from both the sternotomy incision and the chest tube insertion sites and may impair mobilisation, deep breathing, and coughing. Fascial plane blocks of the chest wall, such as parasternal block and serratus anterior plane block, are increasingly used because they are technically simple and have a low complication risk. Previous observational data suggested that combining bilateral parasternal block and serratus anterior plane block provides effective analgesia after CABG, but sample size was small and no randomized comparison has been performed.
Objectives: The primary objective is to compare postoperative pain intensity between parasternal block alone and parasternal plus serratus anterior plane block in adult patients undergoing elective CABG with sternotomy. Secondary objectives are to compare total opioid consumption (tramadol via patient-controlled analgesia), need for rescue analgesics, incidence of opioid-related adverse events (e.g. nausea and vomiting), and intensive care unit and hospital length of stay between the two groups.
Methods: This is a prospective, randomized, parallel-group, low-risk interventional study conducted in the Anaesthesiology and Reanimation Department of Ankara Etlik City Hospital. Adult patients (≥18 years) scheduled for elective coronary bypass surgery due to coronary artery disease and classified as ASA II-IV will be screened for eligibility. After induction of general anaesthesia and before surgical incision, all patients will receive an ultrasound-guided bilateral parasternal block. Patients randomized to the experimental arm will additionally receive a bilateral serratus anterior plane block. Local anaesthetic dosing will follow routine clinical practice, with a total dose not exceeding 2 mg/kg of 0.25% bupivacaine. All patients will receive 40 ml of 0.25% bupivacaine. The parasternal group will receive a bilateral parasternal block via administering 20 ml of 0.25% bupivacaine bilaterally. The parasternal+serratus anterior plane block group will receive 10 ml of 0.25% bupivacaine to bilateral parasternal and deep serratus planes.
Pain intensity will be assessed using the Numeric Rating Scale (NRS, 0-10) at extubation (T0) and postoperative 4, 6, 12, and 24 hours (T4, T6, T12, T24). Postoperative analgesia will include standard intravenous acetaminophen and tramadol via patient-controlled analgesia; total tramadol dose (demand and delivered), rescue analgesic requirement, and adverse events will be recorded in the first 24 postoperative hours.
Sample size: Based on a two-group comparison with an effect size of 0.6, α = 0.0,5, and β = 0.2, 72 patients are required to achieve 80% power.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ankara
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Yenimahalle, Ankara, Turkey (Türkiye), 06810
- Etlik City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
- Age ≥ 18 years
- American Society of Anesthesiologists (ASA) physical status III-IV
- Scheduled for elective coronary artery bypass grafting surgery with sternotomy for coronary artery disease
- Able to provide written informed consent
Exclusion Criteria
- Allergy or contraindication to local anaesthetic agents
- Minimally invasive bypass surgery or off-pump procedures planned
- Emergency cardiac surgery
- Preoperative Numeric Rating Scale (NRS) pain score ≥ 3
- Chronic opioid use in the preoperative period
- Infection or structural abnormality at planned block sites
- Any condition preventing postoperative pain assessment or PCA use (e.g. severe cognitive impairment)
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 |
|---|---|
|
Active Comparator: Arm A: Parasternal Block
After induction of general anaesthesia and before skin incision, an ultrasound-guided bilateral parasternal intercostal plane block will be performed.
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After induction of general anaesthesia and before skin incision, an ultrasound-guided bilateral parasternal intercostal plane block will be performed.
A linear ultrasound probe will be placed parasagittally at the 2nd and 4th intercostal spaces approximately 2-3 cm lateral to the sternum.
A block needle will be advanced in-plane beneath the pectoralis major muscle and above the internal intercostal muscles, and local anaesthetic (0.25% bupivacaine) will be injected bilaterally.
Total dose will not exceed 2 mg/kg.
Postoperative systemic analgesia (patient-controlled analgesia) will be identical in both groups.
|
|
Experimental: Arm B: Serratus Anterior Plane Block
In addition to the bilateral parasternal block described for the comparator arm, patients randomized to the experimental arm will receive an ultrasound-guided bilateral serratus anterior plane block.
|
After induction of general anaesthesia and before skin incision, an ultrasound-guided bilateral parasternal intercostal plane block will be performed.
A linear ultrasound probe will be placed parasagittally at the 2nd and 4th intercostal spaces approximately 2-3 cm lateral to the sternum.
A block needle will be advanced in-plane beneath the pectoralis major muscle and above the internal intercostal muscles, and local anaesthetic (0.25% bupivacaine) will be injected bilaterally.
Total dose will not exceed 2 mg/kg.
Postoperative systemic analgesia (patient-controlled analgesia) will be identical in both groups.
In addition to the bilateral parasternal block described for the comparator arm, patients randomized to the experimental arm will receive an ultrasound-guided bilateral serratus anterior plane block.
With the patient in supine position, the linear ultrasound probe will be placed over the 6th rib in the anterior axillary line.
The needle will be advanced in-plane beneath the serratus anterior muscle and above the rib, and 0.25% bupivacaine will be injected into the fascial plane on each side.
The combined total dose of local anaesthetic for both blocks will not exceed 2 mg/kg.
Postoperative systemic analgesia will be identical in both groups.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Tramadol Consumption
Time Frame: 24-hour post-extubation
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Cumulative dose of tramadol (mg) delivered by patient-controlled analgesia (PCA) in the first 24 hours post-extubation
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24-hour post-extubation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Resting Numeric Rating Scale (NRS) Pain Score
Time Frame: 24 hour post-extubation
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NRS score during rest (0= no pain, 10= worst imaginable pain)
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24 hour post-extubation
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Dynamic Numeric Rating Scale (NRS) Pain Score
Time Frame: 24-hour post-extubation
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NRS score during coughing or deep inspiration (0= no pain, 10= worst imaginable pain)
|
24-hour post-extubation
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Collaborators and Investigators
Publications and helpful links
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 (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PS_SAPB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
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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