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Efficacy of TTMPB in Adult Cardiac Surgery

NCT05681507 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2023-01-23

No results posted yet for this 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.

Conditions

  • Acute Post Operative Pain

Interventions

DRUG

Transversus thoracic muscle plane block

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

PROCEDURE

Standard postoperative analgesia

Standard of postoperative ICU analgesic care, per institutional protocol

Sponsors & Collaborators

  • Eric Albrecht

    lead OTHER

Principal Investigators

  • Valentina Rancati, Attending physician · Centre Hospitalier Universitaire Vaudois

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2023-12-31
Completion
2024-05-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05681507 on ClinicalTrials.gov