Serratus Anterior Plane Block in Pediatric Patients

Cairo University (CU)

Status: Completed

Conditions: Anesthesia, Local

Treatments: Drug: Fentanyl; Procedure: Serratus Anterior Plan Block+ Fentanyl infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT04444635

N110-2020

Details and patient eligibility

About

The aim of this work is to study the efficacy of ultrasound guided serratus anterior plane block in pediatric patients undergoing thoracic surgeries.

It is a randomized controlled trial.

Full description

It is a prospective randomized controlled study. It is designed to estimate and compare the analgesic effect of single shot serratus anterior plane block in pediatric patients undergoing thoracic surgeries with fentanyl infusion versus fentanyl infusion alone as the control group. Our primary outcome will be the total dose of intra-operative fentanyl boluses.

Randomization will be achieved by using an online random number generator. Blindness will be achieved by patient codes which will be placed into sequentially numbered sealed opaque envelopes by a research assistant who is not involved in the study. A physician not involved in patient management will be responsible for opening the envelope and give the instructions contained within each envelope to the anaesthesiologist who is expert in doing the serratus anterior plane block in patients included within the block group. This expert anaesthesiologist will not be involved in collecting data but another anaesthesia doctor will be responsible for patient management and collecting the intraoperative and postoperative data.

Enrollment: 70 patients

Sex: All

Ages: 6 months to 3 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: 6 months-3 years.
• American Society of anesthesiology (ASA) I and II.
• Pediatric patients undergoing thoracic surgeries (with anterior thoracotomy incision).

Exclusion criteria

• Patients whose parents or legal guardians refusing to participate.
• Preoperative mechanical ventilation.
• Known or suspected coagulopathy.
• Infection at the site of injection.
• Known or suspected allergy to any of the studied drugs.
• Elevated liver enzymes more than the normal values.
• Procedures with anticipated significant hemodynamic stability.
• Renal function impairment (Creatinine value more than 1.2mg/dl or blood urea nitrogen (BUN) more than 20mg/dl).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups

Serratus Anterior Plan block plus fentanyl infusion

Active Comparator group

Description:

The patients will receive serratus anterior block in addition to continous intraoperative fentanyl infusion.

Treatment:

Drug: Fentanyl

Procedure: Serratus Anterior Plan Block+ Fentanyl infusion

Fentanyl infusion only

Active Comparator group

Description:

The patient will receive fentanyl infusion only.

Treatment:

Drug: Fentanyl