Serratus Anterior Plane Block in Pediatric Patients

NCT04444635 | Completed DMC

• 1 other identifier: N110-2020
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia, Local

Keywords

Serratus anterior plane block; Pediatric; Thoracotomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Total dosage of additional fentanyl boluses usage in micrograms intraoperatively

  12 months

• First rescue analgesia

  12 months

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

  12 months

• Intra and postoperative heart rate.

  12 months

• Intraoperative and postoperative systolic blood pressure.

  12 months

Study Arms (2)

Serratus Anterior Plan block plus fentanyl infusion

ACTIVE COMPARATOR

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

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

Fentanyl infusion only

ACTIVE COMPARATOR

The patient will receive fentanyl infusion only.

Drug: Fentanyl

Interventions

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

Also known as: Serratus Anterior Plan Block

Serratus Anterior Plan block plus fentanyl infusion

Fentanyl DRUG

Continuous fentanyl infusion throughout the surgical procedure.

Fentanyl infusion only; Serratus Anterior Plan block plus fentanyl infusion

Eligibility Criteria

• Age: 6 Months - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University Hospitals

Cairo, 11562, Egypt

Location

Related Publications (5)

• 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.

  PMID: 15668207 BACKGROUND

• 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.

  PMID: 11772793 BACKGROUND

• 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.

  PMID: 11020770 BACKGROUND

• 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.

  PMID: 11825739 BACKGROUND

• 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.

  PMID: 23923989 RESULT

MeSH Terms

Interventions

Fentanyl

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• AHMED ISMAIL, Lecturer

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: June 20, 2020
• First Posted: June 23, 2020
• Study Start: June 14, 2020
• Primary Completion: June 10, 2021
• Study Completion: June 20, 2021
• Last Updated: June 25, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)