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

Sponsor

National Cancer Institute, Egypt (Other)

Overall Status

Recruiting

CT.gov ID

NCT05153720

Collaborator

(none)

Enrollment

Location

Arms

11.4

Anticipated Duration (Months)

6.9

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Analgesia	Procedure: Erector spinae plane block Procedure: Caudal block	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

78 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Dec 20, 2021

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ultrasound guided erector spinae plane block Unilateral erector spinae plane block will be performed under ultrasound guidance	Procedure: Erector spinae plane block Ultrasound guided erector spinae plane block
Active Comparator: Ultrasound guided caudal block Caudal block will be formed under ultrasound guidance	Procedure: Caudal block Ultrasound guided caudal block

Arm

Intervention/Treatment

Experimental: Ultrasound guided erector spinae plane block

Unilateral erector spinae plane block will be performed under ultrasound guidance

Procedure: Erector spinae plane block

Ultrasound guided erector spinae plane block

Active Comparator: Ultrasound guided caudal block

Caudal block will be formed under ultrasound guidance

Procedure: Caudal block

Ultrasound guided caudal block

Outcome Measures

Primary Outcome Measures

opioid consumption [First 24 hours postoperatively]
postoperative morphine consumption

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 12 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Walaa Y Elsabeeny	Cairo		Egypt	11796

Sponsors and Collaborators

National Cancer Institute, Egypt

Investigators

Principal Investigator: Walaa Y Elsabeeny, MD, Lecturer 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Walaa Youssef Elsabeeny, Lecturer of Anesthesia and Pain management, National Cancer Institute, Egypt

ClinicalTrials.gov Identifier:

NCT05153720

Other Study ID Numbers:

AP2109-30109

First Posted:

Dec 10, 2021

Last Update Posted:

Jan 10, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Agnosia

Study Results

No Results Posted as of Jan 10, 2022