PECs Block for Pacemaker Insertion in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-20

Study Completion Date

2022-08-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Evaluation of Ultrasound Guided Modified Pectoral Nerves Blocks in Transvenous Subpectoral pacemaker insertion in Children: Randomized Controlled Trial

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effective Use of Pecs and Transversus Thoracics Plane Blocks for Subcutaneous Cardiac Pacemaker Insertion: A Case Series

NCT03899701

Anesthesia, Local

WITHDRAWN NA

Truncal Ultrasound Guided Regional Anesthesia for Implantation and Revision of Automatic Implantable Cardioverter Defibrillators (AICDs) and Pacemakers in Pediatric Patients

NCT04184349

Analgesia After Pacemaker AICDS Implantation Pediatrics

COMPLETED PHASE4

Characterization of Cardiac Electrophysiological Effects of Autonomic Neuromodulation

NCT05377216

Ventricular Tachycardia

RECRUITING EARLY_PHASE1

Safety and Effectiveness of Left Bundle Branch Pacing in Patients With Cardiac Dysfunction and AV Block

NCT05553626

Atrioventricular Block, Second and Third Degree Heart Failure Left Bundle Branch Pacing

UNKNOWN NA

Percutaneous Inferior Cervical Sympathetic Block for Treatment of Refractory Ventricular Tachycardia

NCT04770051

Ventricular Tachycardia

WITHDRAWN PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

BACKGROUND Pectoral nerve blocks (PECs) can reduce intraprocedural anesthetic requirements and postoperative pain. Little is known about the utility of PECs in reducing pain and narcotic use after pacemaker (PM)placement in children. OBJECTIVE The purpose of this study was to determine whether PECs can decrease postoperative pain and opioid use after PM placement in children.

METHODS A single-center controlled trial of pediatric patients undergoing transvenous PM placement between 2020 and 2021 will be performed. Demographics, procedural variables, postoperative pain, and postoperative opioid usage will be compared between patients who undergone PECs and those who undergone conventional anesthetic (Control).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Complete Heart Block

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The patient will be randomly assigned to two equal groups. conventional control group(C) (n=20) where20 children will receive IV paracetamol 20 mg / kg . and Pectoral nerves blocks group (P) (n=20) where 20 children will have PECs Block .

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

An online randomization program (http://www.randomizer.org) will be used to generate random list and to allocate patients into two study groups: Random allocation numbers will be concealed in opaque closed envelops. The patient and investigator performing the block and assessing study outcomes will all be blinded to the study group allocation.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

control

conventional control group(C) (n=20) where20 children will receive IV paracetamol 20 mg / kg and atracurium top ups at a dose of 0.1mg/kg. every 30 minutes.

Group Type ACTIVE_COMPARATOR

paracetamol

Intervention Type DRUG

iv post operative analgesia

PECs

Pectoral nerves blocks group (P) (n=20) where 20 children will have PECs Block and atracurium top ups upon request.

Group Type ACTIVE_COMPARATOR

modifiedPECs block

Intervention Type PROCEDURE

sonar guided pectoral nerve block

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

paracetamol

iv post operative analgesia

Intervention Type DRUG

modifiedPECs block

sonar guided pectoral nerve block

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

perfalgan PECs 2 block

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* congenital or post-operative heart block.

Exclusion Criteria

* ⦁ Redo patient

* History of allergic reactions to local anesthetics.
* Bleeding disorders with International Normalization Ratio( INR) \> 1.5 and/or platelets \< 50 000.
* Rash or signs of infection at the injection site.
* Emergency procedure

Minimum Eligible Age

1 Year

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No