Continuous Erector Spinae Block for Post Analgesia in Pediatric Patients

Continuous Erector Spinae Plane Local Anesthetic Infusion for Postoperative Analgesia in Pediatric Patients Undergoing Nephrectomy: Randomized Controlled Study

The aim of this study is to evaluate the analgesic efficacy of erector spinae plane block in pediatric cancer patients undergoing open nephrectomy

Study Overview

• Status: Completed
• Conditions: Pediatric Cancer
• Intervention / Treatment: Drug: Bupivacaine Hydrochloride; Drug: Tramadol hydrochloride

Detailed Description

• Sixty patients will be included in this prospective randomized study. The patients will be allocated into two groups: the ESPB group (group E, n = 30) and the tramal group (group T, n =30).
• All patients will receive standard general anesthesia. Ultrasound-guided ESPB will be performed to group erector spinae plane block

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Assuit, Egypt, 171516
    • South Egypt Cancer instIitute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 7 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Physical status ASA II.
• Patients (age 2-7yrs) scheduled for open nephrectomy for malignant kidney tumors

Exclusion Criteria:

• History of psychological disorders.

  • Known sensitivity or contraindication to local anesthetics.
  • Localized infection at the site of block.
  • patients with coagulopathy or an (INR ≥ 2)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Erector spinae group; patient will be placed in a sitting position under complete aseptic condition and a cover sheath will be used for the ultrasound probe with an appropriate amount of lubricating gel applied on the probe, a high-frequency linear ultrasound transducer will be placed in a longitudinal orientation 3 cm lateral to the L3 spinous process. This should reveal three muscles superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae.	Drug: Bupivacaine Hydrochloride; The patient will be placed in a sitting position under complete aseptic condition and a cover sheath will be used for the ultrasound probe with an appropriate amount of lubricating gel applied on the probe, a high-frequency linear ultrasound transducer will be placed in a longitudinal orientation 3 cm lateral to the L3 spinous process. This should reveal three muscles superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. then injecte bupivacaine hydrochloride; Other Names: erector spinae block
PLACEBO_COMPARATOR: Opioid GROUP; Patient in group T will intravenously administrate dose of 1 mg/kg/8hr tramal ( opioid) to be increased upon patient needs up to 2mg/kg/6hr as rescue analgesic.	Drug: Tramadol hydrochloride; Patients in group Tramadol will intravenously administrate dose of 1 mg/kg/8hr tramal to be increased upon patient needs up to 2mg/kg/6hr as rescue analgesic; Other Names: opioid group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total amount of opioid consumption in milligram	total amount of opioid consumption in the frist 48hours postoperative	48 hours

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: fatma el sherif, MD, Assiut University

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 20, 2020
• Primary Completion (ACTUAL): November 12, 2022
• Study Completion (ACTUAL): December 1, 2022

Study Registration Dates

• First Submitted: October 23, 2020
• First Submitted That Met QC Criteria: November 2, 2020
• First Posted (ACTUAL): November 3, 2020

Study Record Updates

• Last Update Posted (ESTIMATE): February 3, 2023
• Last Update Submitted That Met QC Criteria: February 1, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Opioid; Narcotics; Anesthetics, Local; Bupivacaine; Tramadol
• Other Study ID Numbers: 515

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes