Serratus Anterior Plane Block Versus Erector Spinae Plane Block. for Thoracotomy in Pediatric Patients

NCT04933877 | Unknown

• 1 other identifier: N5098-2021
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controled trial is designed to compare efficacy and safty of serratus anterior plane block versus erector spinae plane block for thoracotomy in pediatric patients.

Conditions

Anesthesia

Keywords

Erector spinae block; Pediatric; serratus anterior plane block; Thoracotomy

Outcome Measures

Primary Outcomes (1)

• post-operative fentanyl consumption

  amount of fentanyl in mic consumed in the 24 hours postoperatively

  9 month

Secondary Outcomes (7)

• intraoperative fentanyl consumption

  24 hours

• FLACC score at 1,2,4,8,12,24 hours postoperatively

  24 hours

• patient satisfaction

  24 hours

• RASS score

  24 hours

• time of first rescue analgesi

  24 hours

Study Arms (2)

Serratus Anterior Plan block

ACTIVE COMPARATOR

The SAPB was performed in the operative room (OR) after anesthesia induction using the same ultrasound machine (SonoSite) and linear ultrasound transducer 8- 12 Hz. The patient was positioned in a lateral position with the operative side up and arm flexed forward; then, a linear ultrasound transducer was placed in a sagittal plane over the mid-clavicular line of the thoracic cage. Then, moving inferior-lateral direction till the fifth rib was identified in the mid-axillary line. The following structures were recognized: the rib, pleura, teres major muscle (superior), latissimus dorsi muscle (superficial and posterior), and serratus muscles muscle (deep and inferior). Under complete sterile conditions, a 22-gauge echogenic needle was introduced in-plane with respect to the ultrasound probe targeting the plane deep to the serratus anterior muscle. Then, 0.4 ml/kg of 0.25% bupivacaine was injected with continuous ultrasound guidance.

Procedure: Fascial plane block

Erector spinae plane block

ACTIVE COMPARATOR

Patients in Group ESPB receive US erector spinae plane block by injecting 0.4ml/kg (bupivacaine 0.25%). Under strict aseptic precautions, The T3 spinous process is located by palpating and counting down from the C7 spinous process. A high-frequency 12 MHz linear ultrasound transducer is placed in a longitudinal orientation 3 cm lateral to the T3 spinous process corresponding to the T2 transverse process. Three muscles; trapezius (uppermost), rhomboids major (middle), and erector spinae (lowermost) will be identified superior to the hyperechoic transverse process.Using an in-plane approach a 22 G needle is inserted in caudal-cephalad direction until the tip is deep to erector spinae muscle. Correct needle tip location is confirmed by injecting 3 mL of normal saline and visualizing the linear LA spread (i.e., hydrodissection) in the fascial plane between the erector spinae muscle and the transverse process. Then, bupivacaine is injected, and visualizing the fascial plane.

Procedure: Fascial plane block

Interventions

Fascial plane block PROCEDURE

Serratus anterior plane block

Erector spinae plane block; Serratus Anterior Plan block

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 1 to 10-year-old
• ASA I, II, and II

You may not qualify if:

• Patients whose parents or legal guardians refusing to participate.
• Preoperative mechanical ventilation.
• Preoperative inotropic drug infusion.
• Known or suspected coagulopathy.

Sponsors & Collaborators

• Cairo University: lead
• Misr University for Science and Technology: collaborator

Study Sites (1)

Misr University For Science And Technology

Giza, 11562, Egypt

RECRUITING

Related Publications (2)

• Gaballah KM, Soltan WA, Bahgat NM. Ultrasound-Guided Serratus Plane Block Versus Erector Spinae Block for Postoperative Analgesia After Video-Assisted Thoracoscopy: A Pilot Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2019 Jul;33(7):1946-1953. doi: 10.1053/j.jvca.2019.02.028. Epub 2019 Feb 21.

  PMID: 30930141 BACKGROUND

• Finnerty DT, McMahon A, McNamara JR, Hartigan SD, Griffin M, Buggy DJ. Comparing erector spinae plane block with serratus anterior plane block for minimally invasive thoracic surgery: a randomised clinical trial. Br J Anaesth. 2020 Nov;125(5):802-810. doi: 10.1016/j.bja.2020.06.020. Epub 2020 Jul 11.

  PMID: 32660716 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: It is double-blinded study. it is blinded to the participants and medical staff who record medical data for the patients.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: June 22, 2021
• Study Start: March 1, 2021
• Primary Completion: February 1, 2023
• Study Completion: April 1, 2023
• Last Updated: October 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)