Comparison of Post-operative Analgesia in Pediatric Superficial TTMPB (PEPOST)

August 29, 2023 updated by: Eric Albrecht, Centre Hospitalier Universitaire Vaudois

When a patient is to undergo heart surgery with a sternotomy, a transthoracic block is performed. The thoracic block is an analgesic technique which consists of injecting anesthetic product into the nerves, in order to avoid significant pain. The common technique is to make injections in the sternum by the surgeon. A new, increasingly widespread method is performed by the anesthetist who performs the block under ultrasound.

This research project aims to determine if performing this transthoracic block under ultrasound is more effective than injections performed by the surgeon without ultrasound.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Cardiac surgery, and more specifically associated sternotomy, leads to severe pain in the postoperative period. Adequate analgesia is therefore challenging, but of paramount importance to reduce associated side effects such as pulmonary hypertensive crisis, tachyarrhythmia, systemic hypertension, hypoxia, and increased morbidity and length of stay. Actual opioid crisis and risks associated with intravenous analgesics raises the question of having an alternative and better approach to relieve severe pain. Currently in the postoperative suites opiates are also used for sedative purposes. This strategy of sedation has to change. Recent advances in regional anaesthesia could be the answer.

Thoracic epidural or paravertebral blocks provide effective analgesia for open cardiac surgery in paediatric patients. However, the major risk of epidural hematomas caused by heparinization, hemodynamic instability, technical difficulties and pneumothorax has limited the application of these two techniques in open cardiac surgery, and promoted the development of new approaches with safe, reliable, and cost-effective techniques, such as ultrasound-guided peripheral nerve blocks. This might be the most effective method for pain management in paediatric patients undergoing cardiac surgery according to recent studies. Superficial Thoracic Transversus Muscle Plane Block has been recently described and evaluated for pain management in adult cardiac surgery. It works through the blockade of multiple anterior branches of the intercostal nerves (Th2-6) in the internal mammary region. It has also been described in children in a few papers: Zhang and al. in a randomized controlled trial in 100 children, Abdelbaser and al. conducted a randomized double blind study including 80 children. In these studies, the injection of local anaesthetics was made between the intercostal and transversus thoracis muscles. But in very small children, the risk of pleura or internal mammary artery puncture associated with this injection is relatively important. Superficial TTMPB (located between the intercostal and pectoralis major muscles) seems to have the same analgesic potency without the aforementioned risks.That is to say that TTMPB is better than nothing but, to our knowledge, there is no study comparing infiltration by surgeon and TTMPB.

The risks of the procedure are the same with all regional anaesthesia, which are vascular or nerves punction, hematoma and failure of anaesthesia.

This study is set up to test the hypothesis that analgesia performed by TTMPB may have a better antalgic effect than blocks made by surgeons, in patients who undergo cardiac sternotomy. At first, the standard in CHUV was injections made by surgeon. Nowadays the decision of technic used is made with a discussion between anesthesist and surgeon during operative time. The investigators want to bring an evidence based decision with this study.

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 16 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All patients undergoing sternotomy for a cardiac surgery in CHUV, which is an academic hospital in Switzerland.

Participants fulfilling all of the following inclusion criteria are eligible for the study :

  • Informed Consent as documented by signature.
  • Age from 0 to 16 years old.
  • Undergoing cardiac surgery with sternotomy in CHUV, Lausanne.

Exclusion Criteria:

  • • Patients older than 16 years.

    • Pregnancy.
    • Sternotomy for operation other than cardiac surgery.
    • Contraindication to local anesthesic, e.g. known hypersensitivity or allergy to Bupivacaine.
    • Infection at the site of injection.
    • Not having consented for this procedure/ refusal of participation. Reoperation during the same hospitalisation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control
Infiltration will be performed by surgeon at the site of sternotomy
Procedure: Control
Infiltration by surgeon
Active Comparator: With TTMPB
Regional anesthesia is performed with direct view of the nerves and vascular position
Procedure: Transversus Thoracic Muscle Plane Block
The transversus thoracic muscle plane block It is most commonly performed following cardiothoracic surgeries (or any surgeries requiring sternotomy) to provide analgesia to the anterior chest wall. he TTMPB, and thoracic fascial plane blocks, are increasingly being employed as part of enhanced recovery after surgery (ERAS) protocols for cardiothoracic procedures. They have been shown to significantly reduce both the time to extubation and the incidence of acute and chronic perioperative pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioids dose
Time Frame: Day 0, Hour 24 post-operative.
Opioids dose administered for analgesia in mg and divided by patient weight in kg
Day 0, Hour 24 post-operative.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioids dose
Time Frame: Day 0 at Hour 4, 12 and Day 1 post-operative
Opioids dose administered for analgesia in mg and divided by patient weight in kg
Day 0 at Hour 4, 12 and Day 1 post-operative
Time to extubation
Time Frame: From the time of arrival in the Intensive Care Unit until the time of extubation assessed up to 3 months
Time to extubation in minutes
From the time of arrival in the Intensive Care Unit until the time of extubation assessed up to 3 months
Dose of catecholamine (noradrenaline) used
Time Frame: At Day 0 Hour 4, 12, 24 and Day 1 post-operative
Total dose per kg infused
At Day 0 Hour 4, 12, 24 and Day 1 post-operative
Length of stay in ICU before discharge
Time Frame: From the time of arrival in the Intensive Care Unit until discharge assessed up to 3 months
Length of stay in ICU before discharge in days
From the time of arrival in the Intensive Care Unit until discharge assessed up to 3 months
Adverse Event
Time Frame: Day 1 post operatively
Analysis of adverse events and adverse events of special interest (complications) such as hematomas, arterial puncture, fail of the block, pneumothorax.
Day 1 post operatively
FLACC pain scale (Face, Legs, Activity, Cry, Consolability)
Time Frame: at Day 0 at Hours 4, 12 and 24 post-operative;
Postoperative pain evaluated by the Flacc pain scale, From 0 to 10 were 10 is the worst pain experimented by the patient and 0 is the normal state.
at Day 0 at Hours 4, 12 and 24 post-operative;

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Vaudois

Investigators

  • Principal Investigator: Sylvain Mauron, MD, Centre Hospitalier Universitaire Vaudois

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

February 23, 2023

First Submitted That Met QC Criteria

March 18, 2023

First Posted (Actual)

March 31, 2023

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PEPOST 2022-01964

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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