Continuous Erector Spinae Block for Post Analgesia in Pediatric Patients

NCT04613830 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: 515
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pediatric Cancer

Outcome Measures

Primary Outcomes (1)

• total amount of opioid consumption in milligram

  total amount of opioid consumption in the frist 48hours postoperative

  48 hours

Study Arms (2)

Erector spinae group

ACTIVE COMPARATOR

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

Opioid GROUP

PLACEBO COMPARATOR

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

Interventions

Bupivacaine Hydrochloride DRUG

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

Also known as: erector spinae block

Erector spinae group

Tramadol hydrochloride DRUG

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

Also known as: opioid group

Opioid GROUP

Eligibility Criteria

• Age: 2 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

South Egypt Cancer instIitute

Asyut, 171516, Egypt

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Bupivacaine; Tramadol

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Dimethylamines; Methylamines; Lipids

Study Officials

• fatma el sherif, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor of anesthesia,ICU and pain management

Study Record Dates

• First Submitted: October 23, 2020
• First Posted: November 3, 2020
• Study Start: November 20, 2020
• Primary Completion: November 12, 2022
• Study Completion: December 1, 2022
• Last Updated: February 3, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)