Serratus Anterior Plane Block in Pediatric Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia, Local
• Intervention / Treatment: Procedure: Serratus Anterior Plan Block+ Fentanyl infusion; Drug: Fentanyl

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11562
    • Cairo University hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Serratus Anterior Plan block plus fentanyl infusion; The patients will receive serratus anterior block in addition to continous intraoperative fentanyl infusion.	Procedure: Serratus Anterior Plan Block+ Fentanyl infusion; 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; Drug: Fentanyl; Continuous fentanyl infusion throughout the surgical procedure.
Active Comparator: Fentanyl infusion only; The patient will receive fentanyl infusion only.	Drug: Fentanyl; Continuous fentanyl infusion throughout the surgical procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The total dose of postoperative operative fentanyl consumption in the first 24 hours.	The total dose of postoperative operative fentanyl consumption in micrograms in the first 24 hours will be calculated	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total dosage of additional fentanyl boluses usage in micrograms intraoperatively	Total dosage of additional fentanyl boluses usage in micrograms intraoperatively	12 months
First rescue analgesia	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.	12 months
Pain assessment postoperatively by Face, Leg, Activity, Cry, Consolability (FLACC) score, minimum is zero, and maximum is 6.	Pain assessment at 30 min, 60 min, 2 hours, 4hours, 8hours postoperatively by FLACC score.	12 months
Intra and postoperative heart rate.	Intra and postoperative heart rate.	12 months
Intraoperative and postoperative systolic blood pressure.	Intraoperative and postoperative systolic blood pressure.	12 months

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• Perkins FM, Kehlet H. Chronic pain as an outcome of surgery. A review of predictive factors. Anesthesiology. 2000 Oct;93(4):1123-33. doi: 10.1097/00000542-200010000-00038. No abstract available.
• Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.
• Rogers ML, Henderson L, Mahajan RP, Duffy JP. Preliminary findings in the neurophysiological assessment of intercostal nerve injury during thoracotomy. Eur J Cardiothorac Surg. 2002 Feb;21(2):298-301. doi: 10.1016/s1010-7940(01)01104-6.
• Senturk M, Ozcan PE, Talu GK, Kiyan E, Camci E, Ozyalcin S, Dilege S, Pembeci K. The effects of three different analgesia techniques on long-term postthoracotomy pain. Anesth Analg. 2002 Jan;94(1):11-5, table of contents. doi: 10.1213/00000539-200201000-00003.
• Lonnqvist PA, Morton NS. Postoperative analgesia in infants and children. Br J Anaesth. 2005 Jul;95(1):59-68. doi: 10.1093/bja/aei065. Epub 2005 Jan 21. No abstract available. Erratum In: Br J Anaesth. 2005 Nov;95(5):725.

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2020
• Primary Completion (Actual): June 10, 2021
• Study Completion (Actual): June 20, 2021

Study Registration Dates

• First Submitted: June 20, 2020
• First Submitted That Met QC Criteria: June 22, 2020
• First Posted (Actual): June 23, 2020

Study Record Updates

• Last Update Posted (Actual): June 25, 2021
• Last Update Submitted That Met QC Criteria: June 23, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Pediatric; Thoracotomy; Serratus anterior plane block
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl
• Other Study ID Numbers: N110-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The patients data are confidential

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No