CClinicalTrials.gg
CompletedNCT04613830Updated Feb 3, 2023

Continuous Erector Spinae Block for Post Analgesia in Pediatric Patients

A Phase 3 interventional study of Bupivacaine Hydrochloride and Tramadol hydrochloride in Pediatric Cancer, sponsored by Assiut University. Completed at 1 site in Egypt. Open to participants aged 2 Years to 7 Years. Per ClinicalTrials.gov, last updated 2023-02-03.

Sponsored by Assiut University · Phase 3, Interventional, and Health services research

From the registry’s dates

  • Primary completion was Nov 2022, 3 years 10 months ago, and no results have been posted to the registry.
Phase
Phase 3
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
2 Years to 7 Years
Sex
All
01

Study summary

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

Read the 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
02

Conditions studied

  • Pediatric Cancer
03

In context

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 7 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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)
05

Study design

Phase
Phase 3
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugBupivacaine 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

    Also known as: erector spinae block

  • DrugTramadol 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

    Also known as: opioid group

06

What researchers measure

Primary outcomes

  1. total amount of opioid consumption in milligram

    total amount of opioid consumption in the frist 48hours postoperative

    Time frame: 48 hours

07

Study locations

1 site
  • South Egypt Cancer instIitute
    Assuit, 171516, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04613830
Lead sponsor
Assiut University
Responsible party
Fatma Adel El sherif,MD (Associated professor of anesthesia,ICU and pain management, Assiut University) — Principal investigator
First posted
Nov 3, 2020
Start date
Nov 20, 2020
Primary completion
Nov 12, 2022
Completion
Dec 1, 2022
Last update
Feb 3, 2023

Study contacts

fatma el sherif, MD
principal investigator · Assiut University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion