- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06625580
Ultrasound-Guided Serratus and Transversus Thoracic Muscle Plane Block Vs. Erector Spinae Plane Block for Acute Poststernotomy Pain
Comparison of Ultrasound-Guided Serratus Anterior and Transversus Thoracic Muscle Plane Block Combination Versus Erector Spinae Plane Block for Acute Poststernotomy Pain Management After Cardiac Surgery
Poststernotomy pain represents a complication that can arise following cardiac surgery. Inadequately managed pain has been linked to various adverse outcomes, including myocardial ischemia, cardiac arrhythmias, heightened coagulation tendencies, pulmonary complications, and elevated incidences of delirium and wound infections.
The Erector Spinae Plane (ESP) block, Serratus Anterior Plane (SAP) block, and Transverse Thoracic Muscle Plane (TTMP) block are demonstrated as effective regional anesthesia techniques for sternotomy pain. While these blocks differ in ease of application and efficacy, the optimal analgesic approach for cardiac surgery remains unclear. The aim of this study is to compare the analgesic efficacy of ultrasound-guided SAP and TTMP blocks combination versus ESP block administered alone in patients undergoing open heart surgery.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Erzurum, Turkey
- Ataturk University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Cardiac Surgery with median sternotomy (valvular and coronary surgeries)
Exclusion Criteria:
- Minimal invasive cardiac surgeries
- Revision surgeries (during postoperative 48 hours)
- Redo cardiac surgeries
- Any contraindications for regional anesthesia technique (any allergies for local anesthetics)
- Preoperative chronic opioid usage
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: ultrasound guided transverse thoracic muscle plane block and serratus anterior plane block
ultrasound guided transverse thoracic muscle plane block and serratus anterior plane block will be performed with %0.25 bupivacaine
|
ultrasound guided transverse thoracic muscle plane block and serratus anterior plane block will be performed with 0.25% bupivacaine
|
|
Active Comparator: ultrasound guided erector spinae plane block
|
ultrasound guided erector spinae plane block will be performed with 0.25% bupivacaine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative opioid consumption
Time Frame: Postoperative 48 hours
|
postoperative opioid consumption will be recorded for 48 hours
|
Postoperative 48 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Visual Analog Scale
Time Frame: Postoperative 48 hours
|
Postoperative Visual Analog Scale assessment will be performed
|
Postoperative 48 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Muhammet Enes Aydin, Associate professor
Publications and helpful links
General Publications
- Aydin ME, Ahiskalioglu A, Ates I, Tor IH, Borulu F, Erguney OD, Celik M, Dogan N. Efficacy of Ultrasound-Guided Transversus Thoracic Muscle Plane Block on Postoperative Opioid Consumption After Cardiac Surgery: A Prospective, Randomized, Double-Blind Study. J Cardiothorac Vasc Anesth. 2020 Nov;34(11):2996-3003. doi: 10.1053/j.jvca.2020.06.044. Epub 2020 Jun 18.
- Muhammad QUA, Sohail MA, Azam NM, Bashir HH, Islam H, Ijaz R, Aquil S, Mansoor T, Dhakal B, Fatima T, Noor J, Khan AS, Iqbal A, Khatri M, Kumar S. Analgesic efficacy and safety of erector spinae versus serratus anterior plane block in thoracic surgery: a systematic review and meta-analysis of randomized controlled trials. J Anesth Analg Crit Care. 2024 Jan 12;4(1):3. doi: 10.1186/s44158-023-00138-y.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- ATATURK-Cardiovascular
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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