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

NCT06601530 | Completed Phase 4

• 1 other identifier: 367860
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Bypass; Anesthesia, Conduction; Nerve Block; Pain, Postoperative

Keywords

Transversus thoracic muscle plane block, postopertive pain, sternotomy

Outcome Measures

Primary Outcomes (7)

• Numeric Rating Scale (NRS) at rest

  Numeric Rating Scale (NRS) for postoperative pain

  Postoperative 24 hours

• Numeric Rating Scale (NRS) during coughing

  Numeric Rating Scale (NRS) for postoperative pain

  Postoperative 24 hours

• Mean arterial pressure

  Postoperative 0, 1, 2, 4, 8, 12 and 24 hours

  Postoperative 24 hours

• Heart rate

  Postoperative 0, 1, 2, 4, 8, 12 and 24 hours

  Postoperative 24 hours

• Mean arterial pressure

  Peroperative induction, before skin incision, after skin incision, before sternotomy and after sternotomy.

  Peroperative

• Heart rate

  Peroperative induction, before skin incision, after skin incision, before sternotomy and after sternotomy.

  Peroperative

• Bispectral Index (BIS)

  Peroperative induction, before skin incision, after skin incision, before sternotomy and after sternotomy.

  Peroperative

Study Arms (2)

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

Procedure: Transversus Thoracic Muscle Plane Block; Drug: Tramadol

Control Group

ACTIVE COMPARATOR

Drug: Tramadol

Interventions

Transversus Thoracic Muscle Plane Block PROCEDURE

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

Also known as: Tramadol

Transversus Thoracic Muscle Plane Block Group

Tramadol DRUG

Tramadol IV PCA (Patient Controlled Analgesia): Basal infusion 0.2 mg/kg/h, bolus 20 mg, lock time 20 minutes

Control Group; Transversus Thoracic Muscle Plane Block Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Fatih, 34098, Turkey (Türkiye)

Location

Related Publications (7)

• 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.

  PMID: 28632672 BACKGROUND

• 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.

  PMID: 25900900 BACKGROUND

• 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.

  PMID: 35281480 BACKGROUND

• 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.

  PMID: 34803399 BACKGROUND

• 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.

  PMID: 32717448 BACKGROUND

• 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.

  PMID: 34696966 BACKGROUND

• 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.

  PMID: 32665179 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Tramadol

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Study Officials

• Lale Yüceyar, Prof

  Istanbul University - Cerrahpasa

  STUDY CHAIR

• Nevzat Cem Sayılgan, MD

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 14, 2024
• First Posted: September 19, 2024
• Study Start: August 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: October 1, 2022
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF

Locations

TU (1)