Pain, AcuteNCT06625580
Ultrasound-Guided Serratus and Transversus Thoracic Muscle Plane Block Vs. Erector Spinae Plane Block for Acute Poststernotomy Pain
A study testing transverse thoracic muscle plane and serratus anterior plane block and erector spinae plane block in people with Pain, Acute and Pain, Chest, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute, Pain, Chest
- What is being tested?
- transverse thoracic muscle plane and serratus anterior plane block and erector spinae plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 1 Jul 2024
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cardiac Surgery with median sternotomy (valvular and coronary surgeries)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Pain, Acute, Pain, Chest
- Being tested
- transverse thoracic muscle plane and serratus anterior plane block, erector spinae plane block
- Medical subject headings
- Acute Pain, Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transverse thoracic muscle plane and serratus anterior plane blockProcedure or surgery
ultrasound guided transverse thoracic muscle plane block and serratus anterior plane block will be performed with 0.25% bupivacaine
erector spinae plane blockProcedure or surgery
ultrasound guided erector spinae plane block will be performed with 0.25% bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| ultrasound guided transverse thoracic muscle plane block and serratus anterior plane block | Active comparator | ultrasound guided transverse thoracic muscle plane block and serratus anterior plane block will be performed with %0.25 bupivacaine Receives: Procedure: transverse thoracic muscle plane and serratus anterior plane block |
| ultrasound guided erector spinae plane block | Active comparator | ultrasound guided erector spinae plane block Receives: Procedure: erector spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative opioid consumption
postoperative opioid consumption will be recorded for 48 hours
Measured: Postoperative 48 hours
Secondary outcomes (1)
Postoperative Visual Analog Scale
Postoperative Visual Analog Scale assessment will be performed
Measured: Postoperative 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start1 Sep 2023
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
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 Pain, AcuteStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed E Aydin, Ataturk University
- Investigators
- Muhammet Enes Aydin, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06625580
- Sponsor's protocol ID
- ATATURK-Cardiovascular
- Status last verified
- Aug 2023
- First submitted
- 22 Sep 2024
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 32665179Muhammad 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.
PubMed 38217050
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06625580
- Acronym / sponsor ID
- ATATURK-Cardiovascular
- Conditions
- Pain, Acute, Pain, Chest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 3 Oct 2024 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ultrasound guided transverse thoracic muscle plane block and serratus anterior plane block | Active comparator | Procedure: transverse thoracic muscle plane and serratus anterior plane blockultrasound guided transverse thoracic muscle plane block and serratus anterior plane block will be performed with %0.25 bupivacaine |
| ultrasound guided erector spinae plane block | Active comparator | Procedure: erector spinae plane blockultrasound guided erector spinae plane block |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cardiac Surgery with median sternotomy (valvular and coronary surgeries)
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| transverse thoracic muscle plane and serratus anterior plane blockultrasound guided transverse thoracic muscle plane block and serratus anterior plane block will be performed with 0.25% bupivacaine | Procedure or surgery | ultrasound guided transverse thoracic muscle plane block and serratus anterior plane block |
| erector spinae plane blockultrasound guided erector spinae plane block will be performed with 0.25% bupivacaine | Procedure or surgery | ultrasound guided erector spinae plane block |
Primary outcome
Postoperative opioid consumption
Time frame: Postoperative 48 hours
postoperative opioid consumption will be recorded for 48 hours
1 secondary outcome
Postoperative Visual Analog Scale
Time frame: Postoperative 48 hours
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 3 Oct 2024.
- Background: PubMed 32665179Aydin 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.
- Background: PubMed 38217050Muhammad 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.
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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. This study is not recruiting at the moment.
Muhammet Enes Aydin principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transverse thoracic muscle plane and serratus anterior plane block and erector spinae plane block in people with Pain, Acute and Pain, Chest, run by Ataturk 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 3 Oct 2024. 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 opioid consumption (time frame: Postoperative 48 hours). 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 NCT06625580, 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 3 Oct 2024.