Serratus Anterior Plane Block in Pediatric Patients

Anesthesia, Local Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04444635
• Other study ID #: N110-2020
• Status: Completed
• Phase: N/A
• Start date: June 14, 2020
• Est. completion date: June 20, 2021

Study information

• Verified date: June 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 20, 2021
• Est. primary completion date: June 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 3 Years

Eligibility

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).

Related Conditions & MeSH terms

• Anesthesia, Local

Intervention

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

Drug:
• Fentanyl
Continuous fentanyl infusion throughout the surgical procedure.

Locations

Country	Name	City	State
Egypt	Cairo University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

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. — View Citation

Lönnqvist PA, Morton NS. Postoperative analgesia in infants and children. Br J Anaesth. 2005 Jul;95(1):59-68. Epub 2005 Jan 21. Review. Erratum in: Br J Anaesth. 2005 Nov;95(5):725. — View Citation

Perkins FM, Kehlet H. Chronic pain as an outcome of surgery. A review of predictive factors. Anesthesiology. 2000 Oct;93(4):1123-33. Review. — View Citation

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. — View Citation

Sentürk M, Ozcan PE, Talu GK, Kiyan E, Camci E, Ozyalçin 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total dosage of additional fentanyl boluses usage in micrograms intraoperatively	Total dosage of additional fentanyl boluses usage in micrograms intraoperatively	12 months
Secondary	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
Secondary	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
Secondary	Intra and postoperative heart rate.	Intra and postoperative heart rate.	12 months
Secondary	Intraoperative and postoperative systolic blood pressure.	Intraoperative and postoperative systolic blood pressure.	12 months