Continuous Erector Spinae Block for Post Analgesia in Pediatric Patients

NCT ID: NCT04613830

Last Updated: 2023-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-20

Study Completion Date

2022-12-01

Brief Summary

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

Detailed Description

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* 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

Conditions

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Pediatric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Bupivacaine Hydrochloride

Intervention Type 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

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.

Group Type PLACEBO_COMPARATOR

Tramadol hydrochloride

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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erector spinae block opioid group

Eligibility Criteria

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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)
Minimum Eligible Age

2 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Fatma Adel El sherif,MD

Associated professor of anesthesia,ICU and pain management

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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fatma el sherif, MD

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

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South Egypt Cancer instIitute

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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515

Identifier Type: -

Identifier Source: org_study_id

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