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Completed

NCT Number: NCT04613830

Continuous Erector Spinae Block for Post Analgesia in Pediatric Patients

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

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Key information

Age range

2 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

South Egypt Cancer instIitute

Asyut, 171516, Egypt

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Other names: erector spinae block

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

Other names: opioid group

Primary outcomes

  1. total amount of opioid consumption in milligram

    Time frame: 48 hours

    total amount of opioid consumption in the frist 48hours postoperative

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 3, 2020
Registry last updated
Feb 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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