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Completed

NCT Number: NCT04444635

Serratus Anterior Plane Block in Pediatric Patients

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.

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Key information

Conditions

Anesthesia, Local

Age range

6 month–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University Hospitals

Cairo, 11562, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Serratus Anterior Plan Block+ Fentanyl infusion

Procedure

After induction of anesthesia, the patients will be put on the lateral position with the diseased side up. A linear ultrasound transducer will be placed in a sagittal plane over the mid-clavicular region of the thoracic cage.

Then counting down ribs till the fifth rib will be identified in the mid-axillary line. The following muscles will be identified overlying the fifth rib: the latissimus dorsi (superficial and posterior),teres major (superior) and serratus muscles (deep and inferior). Under complete sterile conditions, the needle (25 G needle) will be introduced in-plane with respect to the ultrasound probe targeting the plane superficial to the serratus anterior muscle. Then, 2 mg/kg of 0.25% bupivacaine will be injected with continuous ultrasound guidance. In addition to continuous fentanyl infusion

Other names: Serratus Anterior Plan Block

Fentanyl

Drug

Continuous fentanyl infusion throughout the surgical procedure.

Primary outcomes

  1. The total dose of postoperative operative fentanyl consumption in the first 24 hours.

    Time frame: 12 months

    The total dose of postoperative operative fentanyl consumption in micrograms in the first 24 hours will be calculated

Secondary outcomes

  1. Total dosage of additional fentanyl boluses usage in micrograms intraoperatively

    Time frame: 12 months

    Total dosage of additional fentanyl boluses usage in micrograms intraoperatively

  2. First rescue analgesia

    Time frame: 12 months

    Time (in minutes) to 1st rescue analgesia (morphine) post operatively which will be defined to be the elapsed time between stoppage of fentanyl infusion and a patient FLACC score equal or more than 4.

  3. Pain assessment postoperatively by Face, Leg, Activity, Cry, Consolability (FLACC) score, minimum is zero, and maximum is 6.

    Time frame: 12 months

    Pain assessment at 30 min, 60 min, 2 hours, 4hours, 8hours postoperatively by FLACC score.

  4. Intra and postoperative heart rate.

    Time frame: 12 months

    Intra and postoperative heart rate.

  5. Intraoperative and postoperative systolic blood pressure.

    Time frame: 12 months

    Intraoperative and postoperative systolic blood pressure.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Serratus Anterior Plane Block in Pediatric Patients Undergoing Thoracic Surgeries: A Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 23, 2020
Registry last updated
Jun 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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