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

January 17, 2024 updated by: Walaa Youssef Elsabeeny, National Cancer Institute, Egypt

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 12 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
opioid consumption
Time Frame: First 24 hours postoperatively
postoperative morphine consumption
First 24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute, Egypt

Investigators

  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2021

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

November 29, 2021

First Submitted That Met QC Criteria

November 29, 2021

First Posted (Actual)

December 10, 2021

Study Record Updates

Last Update Posted (Estimated)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 17, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AP2109-30109

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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