NCT05681507

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 12, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

January 23, 2023

Status Verified

January 1, 2023

Enrollment Period

1.1 years

First QC Date

December 13, 2022

Last Update Submit

January 19, 2023

Conditions

Acute Post Operative Pain

Keywords

Transversus Thoracic Muscle Plane BlockAdult Cardiac SurgerySternotomy

Outcome Measures

Primary Outcomes (1)

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

    Total opioid consumption

    24 hours

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

Procedure: Standard postoperative analgesia

Intervention group

EXPERIMENTAL

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

Transversus thoracic muscle plane blockDRUG

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

Also known as: TTMPB
Intervention group
Standard postoperative analgesiaPROCEDURE

Standard of postoperative ICU analgesic care, per institutional protocol

Control group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHUVaudois

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Valentina Rancati, Attending physician

    Centre Hospitalier Universitaire Vaudois

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Valentina Rancati, Attending physician

CONTACT

0041 79 556 88 68valentina.rancati@chuv.ch

Eric Albrecht, Attending physician

CONTACT

0041 21 314 20 07eric.albrecht@chuv.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Clinical Anesthesia

Study Record Dates

First Submitted

December 13, 2022

First Posted

January 12, 2023

Study Start

December 1, 2022

Primary Completion

December 31, 2023

Study Completion

May 31, 2024

Last Updated

January 23, 2023

Record last verified: 2023-01

Locations

CH(1)