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Transversus Thoracis Muscle Plane Block for Postoperative Pain in Adult Cardiac Surgery

Primary Purpose

Postoperative Pain, Chest Pain, Coronary Artery Bypass

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Transversus Thoracic Muscle Plane Block
Parasternal Intercostal Plane Block
Sponsored by
Muğla Sıtkı Koçman University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring adult cardiac surgery, poststernotomy pain, transversus thoracic muscle plane block, parasternal intercostal block, behavioral pain scale, numeric rating scale

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • American Society of Anesthesiologists physical status II-III
  • Elective coronary artery bypass graft surgery under general anesthesia

Exclusion Criteria:

  • American Society of Anesthesiologists physical status IV
  • Emergency surgery and redo surgery
  • Low cardiac output syndrome, perioperative intra-aortic balloon pump support for any reason, bleeding disorder or abnormal coagulation profile, abnormal hepatic and renal parameters, uncontrolled diabetes mellitus, chronic obstructive pulmonary disease, atrial fibrillation on anticoagulation
  • Allergy to any study drugs, local infection at the block site
  • Opioid abuse

Sites / Locations

  • Mugla Sıtkı Kocman University Training nad research Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Transversus Thoracic Muscle Plane Block (TTMPB) Group

Parasternal Intercostal Block (PSIB) Group

Control Group

Arm Description

At the TTMPB group, the block will be performed by the surgeon before the closure of the sternum by visualizing the muscles and identifying them. In the TTMPB group patients will receive 40 ml %0.375 bupivacaine divided into 4 equal doses between internal intercostal muscle and transversus thoracic muscle at the 2nd and 3rd intercostal space and 4th and 5th intercostal space.

At the PSIB group, the block will be performed by ultrasound guidance after completion of surgery. PSIB Blocks will be performed under ultrasonography guidance using a linear 6 to 13 megahertz ultrasound probe by the anesthesist.In PSIB group patients will receive 40 ml %0.375 bupivacaine divided into 4 equal doses between psoas major muscle and external intercostal muscle at the 2nd and 3rd intercostal space and 4th and 5th intercostal space bilaterally.

At the control group, no intervention for pain management will be done.

Outcomes

Primary Outcome Measures

Postoperative opioid consumption
Tramadol consumption will be assessed by checking patient daily drug order records
Postoperative opioid consumption
Tramadol consumption will be assessed by checking patient daily drug order records

Secondary Outcome Measures

Behavioral Pain Scale
A blinded nurse will assess postoperative pain while they are intubated at the 1st and 4th hour by using 3 subscale Behavioral Pain Scale which ranges from 3 (no pain) to 12 (maximum pain)
Numeric Rating Scale
A blinded nurse will assess postoperative pain during resting and movement at postoperative 12th and 24th hour by using Numeric rating scale at the extubated patient by using 11-point Numerical Rating Scale which ranges from '0' (means no pain) to '10' (means worst pain imaginable)

Full Information

First Posted
October 11, 2020
Last Updated
April 5, 2022
Sponsor
Muğla Sıtkı Koçman University
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1. Study Identification

Unique Protocol Identification Number
NCT04591119
Brief Title
Transversus Thoracis Muscle Plane Block for Postoperative Pain in Adult Cardiac Surgery
Official Title
Bilateral Transversus Thoracis Muscle Plane Block for Acute Postoperative Pain in Adult Coronary Artery Bypass Graft Surgery: A Randomized Controlled Observer Blinded Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 20, 2020 (Actual)
Primary Completion Date
December 20, 2020 (Actual)
Study Completion Date
December 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Muğla Sıtkı Koçman University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Inadequate pain control after coronary artery bypass graft surgery increases mortality and results in a higher incidence of persistent poststernotomy pain syndrome. Our aim is to assess whether ultrasound-guided parasternal intercostal block (PSIB) or surgeon implied transversus thoracic muscle plane block (TTMPB) would improve the postoperative pain scores and decrease tramadol consumption better after coronary artery bypass graft surgery

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Chest Pain, Coronary Artery Bypass, Sternotomy
Keywords
adult cardiac surgery, poststernotomy pain, transversus thoracic muscle plane block, parasternal intercostal block, behavioral pain scale, numeric rating scale

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transversus Thoracic Muscle Plane Block (TTMPB) Group
Arm Type
Active Comparator
Arm Description
At the TTMPB group, the block will be performed by the surgeon before the closure of the sternum by visualizing the muscles and identifying them. In the TTMPB group patients will receive 40 ml %0.375 bupivacaine divided into 4 equal doses between internal intercostal muscle and transversus thoracic muscle at the 2nd and 3rd intercostal space and 4th and 5th intercostal space.
Arm Title
Parasternal Intercostal Block (PSIB) Group
Arm Type
Active Comparator
Arm Description
At the PSIB group, the block will be performed by ultrasound guidance after completion of surgery. PSIB Blocks will be performed under ultrasonography guidance using a linear 6 to 13 megahertz ultrasound probe by the anesthesist.In PSIB group patients will receive 40 ml %0.375 bupivacaine divided into 4 equal doses between psoas major muscle and external intercostal muscle at the 2nd and 3rd intercostal space and 4th and 5th intercostal space bilaterally.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
At the control group, no intervention for pain management will be done.
Intervention Type
Procedure
Intervention Name(s)
Transversus Thoracic Muscle Plane Block
Intervention Description
40 ml %0.375 bupivacaine divided into 4 equal doses will be injected by the surgeon between internal intercostal muscle and transversus thoracis muscle at the 2nd and 3rd intercostal space and 4th and 5th intercostal space
Intervention Type
Procedure
Intervention Name(s)
Parasternal Intercostal Plane Block
Intervention Description
40 ml %0.375 bupivacaine injection will be performed by ultrasound guidance after completion of surgery between psoas major muscle and external intercostal muscle at the 2nd and 3rd intercostal space and 4th and 5th intercostal space bilaterally by anesthesiologist.
Primary Outcome Measure Information:
Title
Postoperative opioid consumption
Description
Tramadol consumption will be assessed by checking patient daily drug order records
Time Frame
Postoperative 24th hour
Title
Postoperative opioid consumption
Description
Tramadol consumption will be assessed by checking patient daily drug order records
Time Frame
Postoperative 1st, 4th and 12th hour
Secondary Outcome Measure Information:
Title
Behavioral Pain Scale
Description
A blinded nurse will assess postoperative pain while they are intubated at the 1st and 4th hour by using 3 subscale Behavioral Pain Scale which ranges from 3 (no pain) to 12 (maximum pain)
Time Frame
postoperative 1st and 4th hour
Title
Numeric Rating Scale
Description
A blinded nurse will assess postoperative pain during resting and movement at postoperative 12th and 24th hour by using Numeric rating scale at the extubated patient by using 11-point Numerical Rating Scale which ranges from '0' (means no pain) to '10' (means worst pain imaginable)
Time Frame
Postoperative 12th and 24th hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists physical status II-III Elective coronary artery bypass graft surgery under general anesthesia Exclusion Criteria: American Society of Anesthesiologists physical status IV Emergency surgery and redo surgery Low cardiac output syndrome, perioperative intra-aortic balloon pump support for any reason, bleeding disorder or abnormal coagulation profile, abnormal hepatic and renal parameters, uncontrolled diabetes mellitus, chronic obstructive pulmonary disease, atrial fibrillation on anticoagulation Allergy to any study drugs, local infection at the block site Opioid abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melike Korkmaz Toker, Assist.Prof
Organizational Affiliation
Mugla Sıtkı Kocman University Department of Anesthesiology and Reanimation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mugla Sıtkı Kocman University Training nad research Hospital
City
Mugla
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
via mail
Citations:
PubMed Identifier
26144912
Citation
Ueshima H, Takeda Y, Ishikawa S, Otake H. RETRACTED: Ultrasound-guided transversus thoracic muscle plane block: a cadaveric study of the spread of injectate. J Clin Anesth. 2015 Dec;27(8):696. doi: 10.1016/j.jclinane.2015.05.013. Epub 2015 Jul 3. No abstract available.
Results Reference
background
PubMed Identifier
24396082
Citation
de la Torre PA, Garcia PD, Alvarez SL, Miguel FJ, Perez MF. A novel ultrasound-guided block: a promising alternative for breast analgesia. Aesthet Surg J. 2014 Jan 1;34(1):198-200. doi: 10.1177/1090820X13515902. No abstract available.
Results Reference
background

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Transversus Thoracis Muscle Plane Block for Postoperative Pain in Adult Cardiac Surgery

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