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Clinical Trials/NCT04613830
NCT04613830
Completed
Phase 3

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

Assiut University1 site in 1 country60 target enrollmentNovember 20, 2020

Overview

Phase
Phase 3
Intervention
Bupivacaine Hydrochloride
Conditions
Pediatric Cancer
Sponsor
Assiut University
Enrollment
60
Locations
1
Primary Endpoint
total amount of opioid consumption in milligram
Status
Completed
Last Updated
3 years ago

Overview

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

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

Registry
clinicaltrials.gov
Start Date
November 20, 2020
End Date
December 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Fatma Adel El sherif,MD

Associated professor of anesthesia,ICU and pain management

Assiut University

Eligibility Criteria

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)

Arms & Interventions

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.

Intervention: 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.

Intervention: Tramadol hydrochloride

Outcomes

Primary Outcomes

total amount of opioid consumption in milligram

Time Frame: 48 hours

total amount of opioid consumption in the frist 48hours postoperative

Study Sites (1)

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