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Status unknownNCT05681507Updated Jan 23, 2023

Efficacy of TTMPB in Adult Cardiac Surgery

An interventional study of Transversus thoracic muscle plane block and Standard postoperative analgesia in Acute Post Operative Pain, sponsored by Eric Albrecht. Status unknown at 1 site in Switzerland. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-01-23.

Sponsored by Eric Albrecht · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Post Operative Pain

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Keywords

  • Transversus Thoracic Muscle Plane Block
  • Adult Cardiac Surgery
  • Sternotomy
03

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
140 participants (estimated)

Study arms

  • Active comparator
    Control group

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

    Procedure: Standard postoperative analgesia

  • Experimental
    Intervention group

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

    Drug: Transversus thoracic muscle plane block

Interventions

  • DrugTransversus thoracic muscle plane block

    Ultrasound guided bilateral parasternal injection of bupivacain 0.375%, 20ml, at 4th thoracic vertebral level.

    Also known as: TTMPB

  • ProcedureStandard postoperative analgesia

    Standard of postoperative ICU analgesic care, per institutional protocol

05

What researchers measure

Primary outcomes

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

    Total opioid consumption

    Time frame: 24 hours

06

Study locations

1 of 1 sites recruiting
  • CHUVaudois
    Lausanne, VD 1011, Switzerland
    Recruiting
07

Registry details

Key details

Study ID
NCT05681507
Lead sponsor
Eric Albrecht
Responsible party
Eric Albrecht (Professor of Clinical Anesthesia, Centre Hospitalier Universitaire Vaudois) — Sponsor-investigator
First posted
Jan 12, 2023
Start date
Dec 1, 2022
Primary completion
Dec 31, 2023 (estimated)
Completion
May 31, 2024 (estimated)
Last update
Jan 23, 2023

Study contacts

Valentina Rancati, Attending physician
Contact
valentina.rancati@chuv.ch
0041 79 556 88 68
Eric Albrecht, Attending physician
Contact
eric.albrecht@chuv.ch
0041 21 314 20 07
Valentina Rancati, Attending physician
principal investigator · Centre Hospitalier Universitaire Vaudois

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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