Coronary Artery BypassPhase 4NCT06601530

Effect of Transversus Thoracic Muscle Plane Block (TTMP) on Analgesia

A Phase 4 study testing Transversus Thoracic Muscle Plane Block and Tramadol in people with Coronary Artery Bypass and Anesthesia, Conduction, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Coronary Artery Bypass, Anesthesia, Conduction, Nerve Block
What is being tested?: Transversus Thoracic Muscle Plane Block and Tramadol
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Aug 2022to 1 Oct 2022
Phase: Phase 4
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

ASA (American Society of Anesthesiologists) classification I-III
Coronary artery bypass graft operation with median sternotomy under elective conditions

Who cannot join

Refusing to participate in the study
Under 18 and over 70
ASA class IV and above
EF (Ejection Fraction) < 40%
Emergency surgery or reoperation
Intraaortic balloon pump placement

Show all 12Show fewer

Known allergy to local anesthetics
Coagulation disorder
Infection at the block site
History of sternotomy
Those with chronic pain complaints and long-term use of analgesics
Patients who could not be extubated within 12 hours after the operation

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Istanbul University-Cerrahpasa
Istanbul, Fatih, 34098

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation of the Efficacy of Transversus Thoracic Muscle Plane Block in Patients Undergoing Coronary Artery Bypass Graft Surgery

In this prospective and controlled study, the investigators investigated the effect of transversus thoracic muscle plane block (TTMP) on analgesia in patients who undergo coronary artery bypass graft (CABG) surgery with median sternotomy. For this purpose, the investigators aimed to compare the hemodynamic responses to surgical incision and sternotomy and, pain intensity, total analgesic consumption, additional analgesic requirements of the patients in the first 24 hours after extubation under postoperative patient-controlled analgesia (PCA) adminisration.

Read the detailed description

Forty-six patients aged 18-70 years, ASA class I-III, who undergo CABG surgery were included in our study. The patients were randomized into the TTKPB group and the control group. Heart rate (HR) and mean arterial pressure (MAP) were recorded before peroperative induction, before skin incision, after skin incision, before sternotomy and after sternotomy. PCA with tramadol was applied after extubation and "Numeric rating scale" NRS scores, total tramadol consumption, number of requests and additional analgesic requirements were recorded at 0, 1, 2, 4, 8, 12 and 24 hours.

Conditions: Coronary Artery Bypass, Anesthesia, Conduction, Nerve Block, Pain, Postoperative
Being tested: Transversus Thoracic Muscle Plane Block, Tramadol
Keywords: Transversus thoracic muscle plane block, postopertive pain, sternotomy
Medical subject headings: Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transversus Thoracic Muscle Plane BlockProcedure or surgery
Also called Tramadol
Transversus thoracic muscle plane block is a single-shot nerve block technique that provides analgesia for the anterior chest wall Tramadol IV PCA (Patient Controlled Analgesia): Basal infusion 0.2 mg/kg/h, bolus 20 mg, lock time 20 minutes
TramadolDrug
Tramadol IV PCA (Patient Controlled Analgesia): Basal infusion 0.2 mg/kg/h, bolus 20 mg, lock time 20 minutes

Study groups in NCT06601530
Study group	Role	What they receive
Transversus Thoracic Muscle Plane Block Group	Experimental	Transversus thoracic muscle plane block is a single-shot nerve block technique that provides analgesia for the anterior chest wall Receives: Procedure: Transversus Thoracic Muscle Plane Block; Drug: Tramadol
Control Group	Active comparator	Not described Receives: Drug: Tramadol

What is being measured

The primary outcome is the main question the study is designed to answer.

Numeric Rating Scale (NRS) at rest
Numeric Rating Scale (NRS) for postoperative pain
Measured: Postoperative 24 hours
Numeric Rating Scale (NRS) during coughing
Numeric Rating Scale (NRS) for postoperative pain
Measured: Postoperative 24 hours
Mean arterial pressure
Postoperative 0, 1, 2, 4, 8, 12 and 24 hours
Measured: Postoperative 24 hours
Heart rate
Postoperative 0, 1, 2, 4, 8, 12 and 24 hours
Measured: Postoperative 24 hours
Mean arterial pressure
Peroperative induction, before skin incision, after skin incision, before sternotomy and after sternotomy.
Measured: Peroperative
Heart rate
Peroperative induction, before skin incision, after skin incision, before sternotomy and after sternotomy.
Measured: Peroperative
Bispectral Index (BIS)
Peroperative induction, before skin incision, after skin incision, before sternotomy and after sternotomy.
Measured: Peroperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 20221 Oct 2022

First posted19 Sep 2024
Study start1 Aug 2022
Primary completion1 Sep 2022
Study completion1 Oct 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Coronary Artery BypassStudies of the same condition, open and under way.
More trials run by Istanbul University - CerrahpasaThe 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06601530
Sponsor's protocol ID: 367860
Status last verified: Sep 2024
First submitted: 14 Sep 2024
Last updated: 19 Sep 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Publications

Fujii S, Vissa D, Ganapathy S, Johnson M, Zhou J. Transversus Thoracic Muscle Plane Block on a Cadaver With History of Coronary Artery Bypass Grafting. Reg Anesth Pain Med. 2017 Jul/Aug;42(4):535-537. doi: 10.1097/AAP.0000000000000607. No abstract available.
PubMed 28632672
Dogan Baki E, Kavrut Ozturk N, Ayoglu RU, Emmiler M, Karsli B, Uzel H. Effects of Parasternal Block on Acute and Chronic Pain in Patients Undergoing Coronary Artery Surgery. Semin Cardiothorac Vasc Anesth. 2016 Sep;20(3):205-12. doi: 10.1177/1089253215576756. Epub 2015 Apr 21.
PubMed 25900900
Hamed MA, Boules ML, Sobhy MM, Abdelhady MA. The Analgesic Efficacy of Ultrasound-Guided Bilateral Transversus Thoracic Muscle Plane Block After Open-Heart Surgeries: A Randomized Controlled Study. J Pain Res. 2022 Mar 5;15:675-682. doi: 10.2147/JPR.S355231. eCollection 2022.
PubMed 35281480
Shokri H, Ali I, Kasem AA. Evaluation of the Analgesic Efficacy of Bilateral Ultrasound-Guided Transversus Thoracic Muscle Plane Block on Post-Sternotomy Pain: A Randomized Controlled Trial. Local Reg Anesth. 2021 Nov 12;14:145-152. doi: 10.2147/LRA.S338685. eCollection 2021.
PubMed 34803399
Abdelbaser II, Mageed NA. Analgesic efficacy of ultrasound guided bilateral transversus thoracis muscle plane block in pediatric cardiac surgery: a randomized, double-blind, controlled study. J Clin Anesth. 2020 Dec;67:110002. doi: 10.1016/j.jclinane.2020.110002. Epub 2020 Jul 24.
PubMed 32717448
Kaya C, Dost B, Dokmeci O, Yucel SM, Karakaya D. Comparison of Ultrasound-Guided Pecto-intercostal Fascial Block and Transversus Thoracic Muscle Plane Block for Acute Poststernotomy Pain Management After Cardiac Surgery: A Prospective, Randomized, Double-Blind Pilot Study. J Cardiothorac Vasc Anesth. 2022 Aug;36(8 Pt A):2313-2321. doi: 10.1053/j.jvca.2021.09.041. Epub 2021 Oct 1.
PubMed 34696966
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 32665179

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
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Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
RecruitingEarly Phase 1
Thiamine Intervention and Coronary Artery Bypass Grafting
Coronary Heart Disease, Coronary Artery Bypass Grafting
Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Anaesthetic Management in Patients Undergoing Coronary Artery Bypass Grafting
Preoperative Fasting, Pulmonary Aspiration During Anesthetic Induction
Active, not recruiting
Investigation of the Effects of Respiratory Muscle Training Combined With Otago Exercises in Elderly Patients Undergoing Coronary Artery Bypass Graft Surgery
Coronary Artery Bypass Graft (CABG)

All Coronary Artery Bypass trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigation of the Efficacy of Transversus Thoracic Muscle Plane Block in Patients Undergoing Coronary Artery Bypass Graft Surgery
ClinicalTrials.gov ID: NCT06601530
Acronym / sponsor ID: 367860
Conditions: Coronary Artery Bypass, Anesthesia, Conduction, Nerve Block, Pain, Postoperative
Keywords: Transversus thoracic muscle plane block, postopertive pain, sternotomy
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: Istanbul University - CerrahpasaUniversity, hospital or other
Study start: 1 Aug 2022 (actual)
Primary completion: 1 Sep 2022 (actual)
Study completion: 1 Oct 2022 (actual)
First posted: 19 Sep 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 2

Arm	Type	Receives
Transversus Thoracic Muscle Plane Block Group	Experimental	Procedure: Transversus Thoracic Muscle Plane Block, Drug: TramadolTransversus thoracic muscle plane block is a single-shot nerve block technique that provides analgesia for the anterior chest wall
Control Group	Active comparator	Drug: Tramadol

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

ASA (American Society of Anesthesiologists) classification I-III
Coronary artery bypass graft operation with median sternotomy under elective conditions

Key exclusion criteria (12 listed)

Refusing to participate in the study
Under 18 and over 70
ASA class IV and above
EF (Ejection Fraction) < 40%
Emergency surgery or reoperation

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
Transversus Thoracic Muscle Plane BlockAlso: TramadolTransversus thoracic muscle plane block is a single-shot nerve block technique that provides analgesia for the anterior chest wall Tramadol IV PCA (Patient Controlled Analgesia): Basal infusion 0.2 mg/kg/h, bolus 20 mg, lock time 20 minutes	Procedure or surgery	Transversus Thoracic Muscle Plane Block Group
TramadolTramadol IV PCA (Patient Controlled Analgesia): Basal infusion 0.2 mg/kg/h, bolus 20 mg, lock time 20 minutes	Drug	Control Group, Transversus Thoracic Muscle Plane Block Group

Primary outcome

Numeric Rating Scale (NRS) at rest
Time frame: Postoperative 24 hours
Numeric Rating Scale (NRS) for postoperative pain
Numeric Rating Scale (NRS) during coughing
Time frame: Postoperative 24 hours
Numeric Rating Scale (NRS) for postoperative pain
Mean arterial pressure
Time frame: Postoperative 24 hours
Postoperative 0, 1, 2, 4, 8, 12 and 24 hours
Heart rate
Time frame: Postoperative 24 hours
Postoperative 0, 1, 2, 4, 8, 12 and 24 hours
Mean arterial pressure
Time frame: Peroperative
Peroperative induction, before skin incision, after skin incision, before sternotomy and after sternotomy.
Heart rate
Time frame: Peroperative
Peroperative induction, before skin incision, after skin incision, before sternotomy and after sternotomy.
Bispectral Index (BIS)
Time frame: Peroperative
Peroperative induction, before skin incision, after skin incision, before sternotomy and after sternotomy.

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 19 Sep 2024.
Background: PubMed 28632672Fujii S, Vissa D, Ganapathy S, Johnson M, Zhou J. Transversus Thoracic Muscle Plane Block on a Cadaver With History of Coronary Artery Bypass Grafting. Reg Anesth Pain Med. 2017 Jul/Aug;42(4):535-537. doi: 10.1097/AAP.0000000000000607. No abstract available.
Background: PubMed 25900900Dogan Baki E, Kavrut Ozturk N, Ayoglu RU, Emmiler M, Karsli B, Uzel H. Effects of Parasternal Block on Acute and Chronic Pain in Patients Undergoing Coronary Artery Surgery. Semin Cardiothorac Vasc Anesth. 2016 Sep;20(3):205-12. doi: 10.1177/1089253215576756. Epub 2015 Apr 21.
Background: PubMed 35281480Hamed MA, Boules ML, Sobhy MM, Abdelhady MA. The Analgesic Efficacy of Ultrasound-Guided Bilateral Transversus Thoracic Muscle Plane Block After Open-Heart Surgeries: A Randomized Controlled Study. J Pain Res. 2022 Mar 5;15:675-682. doi: 10.2147/JPR.S355231. eCollection 2022.
Background: PubMed 34803399Shokri H, Ali I, Kasem AA. Evaluation of the Analgesic Efficacy of Bilateral Ultrasound-Guided Transversus Thoracic Muscle Plane Block on Post-Sternotomy Pain: A Randomized Controlled Trial. Local Reg Anesth. 2021 Nov 12;14:145-152. doi: 10.2147/LRA.S338685. eCollection 2021.
Background: PubMed 32717448Abdelbaser II, Mageed NA. Analgesic efficacy of ultrasound guided bilateral transversus thoracis muscle plane block in pediatric cardiac surgery: a randomized, double-blind, controlled study. J Clin Anesth. 2020 Dec;67:110002. doi: 10.1016/j.jclinane.2020.110002. Epub 2020 Jul 24.
Background: PubMed 34696966Kaya C, Dost B, Dokmeci O, Yucel SM, Karakaya D. Comparison of Ultrasound-Guided Pecto-intercostal Fascial Block and Transversus Thoracic Muscle Plane Block for Acute Poststernotomy Pain Management After Cardiac Surgery: A Prospective, Randomized, Double-Blind Pilot Study. J Cardiothorac Vasc Anesth. 2022 Aug;36(8 Pt A):2313-2321. doi: 10.1053/j.jvca.2021.09.041. Epub 2021 Oct 1.
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.
Individual participant dataSharing planned: Yes

Related trials for Coronary Artery Bypass

Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
RecruitingEarly Phase 1
Thiamine Intervention and Coronary Artery Bypass Grafting
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Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Anaesthetic Management in Patients Undergoing Coronary Artery Bypass Grafting
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Active, not recruiting
Investigation of the Effects of Respiratory Muscle Training Combined With Otago Exercises in Elderly Patients Undergoing Coronary Artery Bypass Graft Surgery
Coronary Artery Bypass Graft (CABG)

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.

Lale Yüceyar, Prof study chair

Istanbul University - Cerrahpasa

Nevzat Cem Sayılgan, MD study director

Istanbul University - Cerrahpasa

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 12 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 19 Sep 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Numeric Rating Scale (NRS) at rest (time frame: Postoperative 24 hours). The study lists 7 primary outcomes in all. 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 NCT06601530, which also lists 7 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 19 Sep 2024.