Erector Spinae Plane Block for Paediatric Upper Abdominal Surgery

February 7, 2023 updated by: Nazmy Edward Seif

Ultrasound-Guided Erector Spinae Plane Block for Paediatric Upper Abdominal Surgery: A Randomized Controlled Study

Upper abdominal surgeries are associated with severe postoperative pain. Thus, maintaining effective postoperative analgesia in the paediatric age group is very crucial in terms of future pain perception and chronic pain development. Erector Spinae Plane Block (ESPB) is an interfascial plane block characterized by its ease of application and low complication rates with the introduction of ultrasonography. The aim of this study is to investigate the analgesic effects of ESPB in this particular age-group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

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 Locations

  • Egypt
      • Cairo, Egypt
        • Cairo University Hospitals

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

2 years to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA I - II.
  • Elective open upper abdominal surgeries, e.g., open cholecystectomy, splenectomy, pyeloplasty, renal cysts excision, partial or total nephrectomy.

Exclusion Criteria:

  • Patient's next of kin refusal.
  • Allergy to local anaesthetics.
  • Infection at the site of injection.
  • Coagulopathy.

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: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ESPB group
Erector Spinae Plain Block
Procedure: Erector Spinae Plain Block
Patients will receive erector spinae plane block (ESP) at the level of T 9-10. Following skin sterilization, high-frequency linear ultrasound probe will be placed 1-2 cm lateral to the midline at the T 9 level. After identification of the erector spinae muscle (ESM) and the transverse process; a 22 G needle will be inserted, in a cranio-caudal direction, deep into the ESM in an in-plane technique. Correct needle placement will be verified with the administration of 0.5-1 ml Normal Saline to view the hydrodissection between the transverse process and the ESM. 0.25% Bupivacaine in a calculated volume of 0.5 ml/kg (with a maximum dose of 20 ml) will be injected deep to the erector spinae muscle for unilateral ESPB.
Procedure: Intra-Venous Analgesia
Post-operative rescue analgesic plan will consist of 15 mg/kg Paracetamol IV if the FLACC [Face, Leg, Activity, Cry, Consolability] score is 2-4 and 1 mg/kg Tramadol IV if FLACC score > 4.
ACTIVE_COMPARATOR: IV Analgesia group
Intra-Venous Analgesia
Procedure: Intra-Venous Analgesia
Post-operative rescue analgesic plan will consist of 15 mg/kg Paracetamol IV if the FLACC [Face, Leg, Activity, Cry, Consolability] score is 2-4 and 1 mg/kg Tramadol IV if FLACC score > 4.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tramadol consumption.
Time Frame: 24 hours
Total dose of Tramadol (measured in mg) given intra-venously to the patient post-operatively.
24 hours

Collaborators and Investigators

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

Sponsor

Nazmy Edward Seif

Investigators

  • Principal Investigator: Atef K Salama, MD, Kasr Al-Ainy Hospital, Faculty of Medicine, 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)

August 20, 2020

Primary Completion (ACTUAL)

December 15, 2022

Study Completion (ACTUAL)

December 15, 2022

Study Registration Dates

First Submitted

August 15, 2020

First Submitted That Met QC Criteria

August 15, 2020

First Posted (ACTUAL)

August 19, 2020

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • USESPBPUAS

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.

Clinical Trials on Analgesia

Clinical Trials on Erector Spinae Plain Block

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe