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Efficacy of TTMPB in Adult Cardiac Surgery

Primary Purpose

Acute Post Operative Pain

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Transversus thoracic muscle plane block
Standard postoperative analgesia
Sponsored by
Eric Albrecht
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Post Operative Pain focused on measuring Transversus Thoracic Muscle Plane Block, Adult Cardiac Surgery, Sternotomy

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Direct informed consent as documented by signature Major adult (≥ 18 years old) with body weight ≥ 50 kg. For the record, fifty kilograms is the minimal weight to ensure that participants remain safely away from maximal doses of LA (3 mg/kg) Planned and primary cardiac surgery via a sternotomy approach Planned for ultra-fast-track procedure (i.e. postoperative extubation time of maximum two hours) Exclusion Criteria: Participation in another study with investigational drug within the 30 days preceding and during the present study Refusal and/or inability to understand or sign the informed consent Emergent cardiac surgery Previous cardiac surgery Known hypersensitivity or true allergy to bupivacaine and other amide-class LA Chronic pain history Substance abuse history Inability to follow the procedures of the study (e.g. due to language problems, psychological / psychiatric disorders, dementia) Clinically significant concomitant diseases: severe cardiac dysfunction (i.e. LVEF ≤ 35%); severe chronic obstructive pulmonary disease (i.e. FEV < 50%); severe hepatic disease. Severe obesity (BMI > 35kg/m2)

Sites / Locations

  • CHUVaudoisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Intervention group

Arm Description

Patients will benefit of our institutional intensive-care unit analgesia protocol

Patients will benefit of a transversus thoracic muscle plane block and our institutional intensive-care unit analgesia protocol

Outcomes

Primary Outcome Measures

Total amount (in mg) of opioid consumption within the first 24 hours
Total opioid consumption

Secondary Outcome Measures

Full Information

First Posted
December 13, 2022
Last Updated
January 19, 2023
Sponsor
Eric Albrecht
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1. Study Identification

Unique Protocol Identification Number
NCT05681507
Brief Title
Efficacy of TTMPB in Adult Cardiac Surgery
Official Title
Efficacy of Transversus Thoracic Muscle Plane Block in Adult Cardiac Surgery: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Eric Albrecht

4. Oversight

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

5. Study Description

Brief Summary
The goal of this clinical trial is to compare the efficacy of Transversus Thoracic Muscle Plane Block (TTMPB) integrated in a modern multimodal analgesia protocol, following the ERAS® recommendations, in adult patients undergoing planned open heart surgery. The main study question is: Does the addition of TTMPB to a standard analgesic protocol significantly improve analgesia following elective open heart surgery? The investigators will primarily compare postoperative opioid consumption and pain scores in patients who will be randomly allocated to one of two groups: The control group will receive standard analgesia per institutional Intensive Care Unit protocol. The intervention group will receive the same standard of care plus a TTMP block (40ml of bupivacaine 0.375%, total dose of 150 mg). The investigators will also study the impact of group allocation on secondary outcomes, such as the rate of early mobilization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Post Operative Pain
Keywords
Transversus Thoracic Muscle Plane Block, Adult Cardiac Surgery, Sternotomy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Patients will benefit of our institutional intensive-care unit analgesia protocol
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Patients will benefit of a transversus thoracic muscle plane block and our institutional intensive-care unit analgesia protocol
Intervention Type
Drug
Intervention Name(s)
Transversus thoracic muscle plane block
Other Intervention Name(s)
TTMPB
Intervention Description
Ultrasound guided bilateral parasternal injection of bupivacain 0.375%, 20ml, at 4th thoracic vertebral level.
Intervention Type
Procedure
Intervention Name(s)
Standard postoperative analgesia
Intervention Description
Standard of postoperative ICU analgesic care, per institutional protocol
Primary Outcome Measure Information:
Title
Total amount (in mg) of opioid consumption within the first 24 hours
Description
Total opioid consumption
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Direct informed consent as documented by signature Major adult (≥ 18 years old) with body weight ≥ 50 kg. For the record, fifty kilograms is the minimal weight to ensure that participants remain safely away from maximal doses of LA (3 mg/kg) Planned and primary cardiac surgery via a sternotomy approach Planned for ultra-fast-track procedure (i.e. postoperative extubation time of maximum two hours) Exclusion Criteria: Participation in another study with investigational drug within the 30 days preceding and during the present study Refusal and/or inability to understand or sign the informed consent Emergent cardiac surgery Previous cardiac surgery Known hypersensitivity or true allergy to bupivacaine and other amide-class LA Chronic pain history Substance abuse history Inability to follow the procedures of the study (e.g. due to language problems, psychological / psychiatric disorders, dementia) Clinically significant concomitant diseases: severe cardiac dysfunction (i.e. LVEF ≤ 35%); severe chronic obstructive pulmonary disease (i.e. FEV < 50%); severe hepatic disease. Severe obesity (BMI > 35kg/m2)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Valentina Rancati, Attending physician
Phone
0041 79 556 88 68
Email
valentina.rancati@chuv.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Albrecht, Attending physician
Phone
0041 21 314 20 07
Email
eric.albrecht@chuv.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valentina Rancati, Attending physician
Organizational Affiliation
Centre Hospitalier Universitaire Vaudois
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHUVaudois
City
Lausanne
State/Province
VD
ZIP/Postal Code
1011
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valentina Rancati, Attending Physician
Phone
0041795568868
Email
valentina.rancati@chuv.ch

12. IPD Sharing Statement

Learn more about this trial

Efficacy of TTMPB in Adult Cardiac Surgery

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