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

September 14, 2024 updated by: Bensu Tavelli, Istanbul University - Cerrahpasa (IUC)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Fatih
      • Istanbul, Fatih, Turkey, 34098
        • Istanbul University-Cerrahpasa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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: Control Group
Drug: Tramadol
Tramadol IV PCA (Patient Controlled Analgesia): Basal infusion 0.2 mg/kg/h, bolus 20 mg, lock time 20 minutes
Experimental: Transversus Thoracic Muscle Plane Block Group
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
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
Other Names:
  • Tramadol
Drug: Tramadol
Tramadol IV PCA (Patient Controlled Analgesia): Basal infusion 0.2 mg/kg/h, bolus 20 mg, lock time 20 minutes

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa (IUC)

Investigators

  • Study Chair: Lale Yüceyar, Prof, Istanbul University - Cerrahpasa (IUC)
  • Study Director: Nevzat Cem Sayılgan, MD, Istanbul University - Cerrahpasa (IUC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

October 1, 2022

Study Registration Dates

First Submitted

September 14, 2024

First Submitted That Met QC Criteria

September 14, 2024

First Posted (Estimated)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 14, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 367860

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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