NCT05153720

Brief Summary

The study aim to compare ultrasound guided erector spinae plane block versus ultrasound guided caudal block in perioperative analgesia for pediatric cancer patients

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 10, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

December 20, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2024

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2024

Completed
Last Updated

September 24, 2024

Status Verified

January 1, 2024

Enrollment Period

2.6 years

First QC Date

November 29, 2021

Last Update Submit

September 22, 2024

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

  • opioid consumption

    postoperative morphine consumption

    First 24 hours postoperatively

Study Arms (2)

Ultrasound guided erector spinae plane block

EXPERIMENTAL

Unilateral erector spinae plane block will be performed under ultrasound guidance

Procedure: Erector spinae plane block

Ultrasound guided caudal block

ACTIVE COMPARATOR

Caudal block will be formed under ultrasound guidance

Procedure: Caudal block

Interventions

Erector spinae plane blockPROCEDURE

Ultrasound guided erector spinae plane block

Ultrasound guided erector spinae plane block
Caudal blockPROCEDURE

Ultrasound guided caudal block

Ultrasound guided caudal block

Eligibility Criteria

Age1 Year - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ASA I and II
  • Age \>1 and \<12
  • patients undergoing nephrectomy surgeries

You may not qualify if:

  • patients parental refusal
  • local infection at the puncture site
  • coagulopathy with INR\> 1.6
  • unstable cardiovascular disease
  • patients allergic to medication used
  • development or mental delay
  • impaired liver and renal functions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walaa Y Elsabeeny

Cairo, 11796, Egypt

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Walaa Y Elsabeeny, MD

    Assistant Professor of Anesthesia and Pain Management, National Cancer Institute, Cairo University

    PRINCIPAL INVESTIGATOR

  • Yasmen F Abdelghani, M.Sc

    Assistant Lecturer of Anesthesia and Pain Management, National Cancer Institute, Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anesthesia and Pain management

Study Record Dates

First Submitted

November 29, 2021

First Posted

December 10, 2021

Study Start

December 20, 2021

Primary Completion

July 26, 2024

Study Completion

July 29, 2024

Last Updated

September 24, 2024

Record last verified: 2024-01

Locations

EG(1)