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Clinical Trials/NCT06546722
NCT06546722
Not Yet Recruiting
N/A

Transversus Thoracic Plane Block for Perioperative Analgesia in Cardiac Surgery: a Randomized Controlled Prospective Study

Saint-Joseph University1 site in 1 country150 target enrollmentSeptember 1, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Transversus Thoracic Plane Block
Sponsor
Saint-Joseph University
Enrollment
150
Locations
1
Primary Endpoint
postoperative pain score
Status
Not Yet Recruiting
Last Updated
last year

Overview

Brief Summary

The goal of this clinical trial is to learn if perioperative Transversus Thoracic Plane Block (TTPB) decrease perioperative pain after cardiac surgery. The main questions it aims to answer are:

  1. does Transversus Thoracic Plane Block decrease perioperative pain after cardiac surgery more than the standard analgesic treatment?
  2. Are the results different if the investigators perform Transversus Thoracic Plane Block before surgery or at the end of surgery?
Registry
clinicaltrials.gov
Start Date
September 1, 2024
End Date
December 30, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Saint-Joseph University
Responsible Party
Principal Investigator
Principal Investigator

Joanna Tohme

Medical Doctor, Principal investigator

Saint-Joseph University

Eligibility Criteria

Inclusion Criteria

  • All patients scheduled for cardiac surgery via sternotomy under cardiopulmonary bypass

Exclusion Criteria

  • Previous cardiac surgery
  • Urgent surgery
  • Pregnant women
  • Allergy to local anesthetics
  • Opioid dependence
  • Low ejection fraction \< 30%
  • Presence or onset of cognitive or neurological disorders preventing pain assessment
  • Infection at injection sites
  • Coagulopathy
  • Patients on dual antiplatelet therapy

Outcomes

Primary Outcomes

postoperative pain score

Time Frame: First 24h postoperatively

The primary outcome is Postoperative Pain Score: Numeric rating scale (NRS) ratings will be assessed at T1 (= upon patient awakening), T2 (= 12 hours postoperatively), T3 (= 24 hours postoperatively) as well as during various painful moments (coughing, drain removal, mobilization). Numeric rating scale (NRS) is a unidimensional measure of pain intensity. It consists of the patient evaluating his pain out of a series of numbers ranging from 0 to 10, where the 2 respective endpoints are "0 = no pain" and "10 = worst possible pain."

Secondary Outcomes

  • Incidence of postoperative pneumonia and pneumothorax in cardiac intensive care unit(First 24h postoperatively)
  • Perioperative opioid requirement(First 24h postoperatively)
  • Time to first opioid administration(First 24h postoperatively)
  • Length of stay at cardiac intensive care unit and hospital stay(3 months postoperatively)
  • Time to extubation(First 24h postoperatively)
  • Patient satisfaction at 24 hours post surgery(First 24h postoperatively)

Study Sites (1)

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