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Erector Spinae Block Versus Caudal Block for Perioperative Analgesia in Pediatric Cancer Patients

Primary Purpose

Analgesia

Status

Recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Erector spinae plane block

Caudal block

About this trial

This is an interventional treatment trial for Analgesia

Eligibility Criteria

1 Year - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Walaa Y ElsabeenyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ultrasound guided erector spinae plane block

Ultrasound guided caudal block

Arm Description

Unilateral erector spinae plane block will be performed under ultrasound guidance

Caudal block will be formed under ultrasound guidance

Outcomes

Primary Outcome Measures

opioid consumption

postoperative morphine consumption

Secondary Outcome Measures

Full Information

NCT ID

NCT05153720

First Posted

November 29, 2021

Last Updated

May 6, 2023

Sponsor

National Cancer Institute, Egypt

1. Study Identification

Unique Protocol Identification Number

NCT05153720

Brief Title

Erector Spinae Block Versus Caudal Block for Perioperative Analgesia in Pediatric Cancer Patients

Official Title

Comparison of Ultrasound Guided Erector Spinae Block and Ultrasound Guided Caudal for Perioperative Analgesia in Pediatric Cancer Patients Undergoing Nephrectomy Surgeries: A Randomized Controlled Study

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 20, 2021 (Actual)

Primary Completion Date

October 2023 (Anticipated)

Study Completion Date

November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Cancer Institute, Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Analgesia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ultrasound guided erector spinae plane block

Arm Type

Experimental

Arm Description

Unilateral erector spinae plane block will be performed under ultrasound guidance

Arm Title

Ultrasound guided caudal block

Arm Type

Active Comparator

Arm Description

Caudal block will be formed under ultrasound guidance

Intervention Type

Procedure

Intervention Name(s)

Erector spinae plane block

Intervention Description

Ultrasound guided erector spinae plane block

Intervention Type

Procedure

Intervention Name(s)

Caudal block

Intervention Description

Ultrasound guided caudal block

Primary Outcome Measure Information:

Title

opioid consumption

Description

postoperative morphine consumption

Time Frame

First 24 hours postoperatively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ASA I and II Age >1 and <12 patients undergoing nephrectomy surgeries Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Walaa Elsabeeny

Phone

01007798466

Ext

walaa.elsabeeny@nci.cu.edu.eg

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Walaa Y Elsabeeny, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Yasmen F Abdelghani, M.Sc

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Walaa Y Elsabeeny

City

Cairo

ZIP/Postal Code

11796

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Walaa Y Elsabeeny, MD

Phone

01007798466

Ext

walaa.elsabeeny@nci.cu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Erector Spinae Block Versus Caudal Block for Perioperative Analgesia in Pediatric Cancer Patients

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