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Transversus Thoracic Muscle Plane Block for Open Heart Surgery (TTMP)

Primary Purpose

Pain, Acute, Pain, Chest

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bupivacaine
Saline
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Acute

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

American Society of Anesthesiologist's physiologic state I-III patients Undergoing Open Heart Surgery

Exclusion Criteria:

chronic pain bleeding disorders renal or hepatic insufficiency patients on chronic non-steroidal anti-inflammatory medications emergency cases

Sites / Locations

  • Ataturk University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

ultrasound guided transverse thoracic muscle plane block

ultrasound guided sham block

Arm Description

Outcomes

Primary Outcome Measures

Postoperative opioid consumption
First 24 hours total fentanyl consumption with patient controlled analgesia

Secondary Outcome Measures

Visual analog pain score
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain)

Full Information

First Posted
September 17, 2019
Last Updated
January 28, 2020
Sponsor
Ataturk University
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1. Study Identification

Unique Protocol Identification Number
NCT04094532
Brief Title
Transversus Thoracic Muscle Plane Block for Open Heart Surgery
Acronym
TTMP
Official Title
Ultrasound Guided Transversus Thoracic Muscle Plane Block for Open Heart Surgery: Randomized Controlled Double Blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
January 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk 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
Poststernotomy pain is a complication of cardiac surgery. Poorly controlled pain is associated with myocardial ischemia, cardiac arrhythmias, hypercoagulability, pulmonary complications, and increased rates of delirium and wound infection. The transverse thoracic muscle plane (TTMP) block is a novel plane block that provide pain for sternotomy. The aim of this study was to evaluate the analgesic effect of ultrasound guided TTMP block in patients undergoing open heart surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute, Pain, Chest

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ultrasound guided transverse thoracic muscle plane block
Arm Type
Active Comparator
Arm Title
ultrasound guided sham block
Arm Type
Sham Comparator
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
Ultrasound guided 20 ml % 0.250 bupivacaine injection to transverse thoracic muscle plane bilaterally
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Ultrasound guided 20 ml % 0.9 saline injection to transverse thoracic muscle plane bilaterally
Primary Outcome Measure Information:
Title
Postoperative opioid consumption
Description
First 24 hours total fentanyl consumption with patient controlled analgesia
Time Frame
first 24 hours
Secondary Outcome Measure Information:
Title
Visual analog pain score
Description
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain)
Time Frame
postextubation 0-24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologist's physiologic state I-III patients Undergoing Open Heart Surgery Exclusion Criteria: chronic pain bleeding disorders renal or hepatic insufficiency patients on chronic non-steroidal anti-inflammatory medications emergency cases
Facility Information:
Facility Name
Ataturk University
City
Erzurum
State/Province
Yakutiye
ZIP/Postal Code
25100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27093277
Citation
Murata H, Hida K, Hara T. Transverse Thoracic Muscle Plane Block: Tricks and Tips to Accomplish the Block. Reg Anesth Pain Med. 2016 May-Jun;41(3):411-2. doi: 10.1097/AAP.0000000000000374. No abstract available.
Results Reference
background

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Transversus Thoracic Muscle Plane Block for Open Heart Surgery

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