Conventional Caudal Block, Ultrasound Guided Caudal Block and Ultrasound Guided Erector Spinae Block for Pediatric Hip Surgery

January 16, 2021 updated by: Eman Hamdy Abu-Shanab, Tanta University

Comparison of Conventional Caudal Block, Ultrasound Guided Caudal Block and Ultrasound Guided Erector Spinae Block for Pediatric Hip Surgery

This study will be conducted to compare the efficacy and safety of ultrasound guided erector spinae block , ultrasound guided caudal block and conventional caudal block for pain management after pediatric hip surgery.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

105

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
    • ElGharbiaa
      • Tanta, ElGharbiaa, Egypt, 31527

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

4 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Both sex
  • ASA physical activity I, II
  • Age 4-12 years
  • Admitted for elective hip surgery.

Exclusion Criteria:

  • Parents refusal
  • Children with severe systemic disease
  • ASA III or IV
  • Children with previous neurological or spinal anomaly, coagulation disorders
  • History of premature birth
  • Infection at the block injection site
  • History of allergy to local anesthetics
  • Bilateral hip surgery.

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
Active Comparator: Conventional caudal block
Patients of this group will receive the conventional method (blind technique without ultrasound) of caudal block
Procedure: Conventional caudal block
Patients of this group will receive (0.5ml/kg) (plain bupivacaine 0.25% injected in the caudal epidural space) by the conventional method (blind technique without ultrasound).
Experimental: Ultrasound-guided caudal block
Patients of this group will receive caudal block using ultrasound.
Procedure: Ultrasound-guided caudal block
Using ultrasound, patients of this group will receive (0.5ml/kg) (plain bupivacaine 0.25% injected in the caudal epidural space).
Experimental: Ultrasound guided erector spinae plane Block
Patients of this group will receive ultrasound guided erector spinae plane Block at the level of the transverse process of the second lumbar vertebrae(L2) .
Procedure: Ultrasound guided erector spinae plane Block
Under ultrasound guidance, patients of this group will receive (0.5ml/kg) (plain bupivacaine 0.25% injected beneath the erector spinae muscle sheath) at the level of the transverse process of the second lumbar vertebrae(L2).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of pain intensity
Time Frame: First 24 hours postoperative
To evaluate the pain scores by (FLACC) scale. (FLACC) scale will be assessed after surgery over 24 hours where (0 = Relaxed and comfortable, 1-3 = Mild discomfort, 4-6 = Moderate pain ,7-10 = Severe discomfort /pain)
First 24 hours postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in mean arterial blood pressure
Time Frame: Intraoperative and first 24 hours postoperative
Mean arterial blood pressure will be recorded before block performance at T0, intraoperatively at 15 and 30 minutes, then every 30 min till the end of surgery and after surgery at T (0, 2, 4, 6, 12, 24 h).
Intraoperative and first 24 hours postoperative
Changes in heart rate
Time Frame: Intraoperative and first 24 hours postoperative
Heart rate will be recorded before block performance at T0, intraoperatively at 15 and 30 minutes, then every 30 min till the end of surgery and after surgery at T (0, 2, 4, 6, 12, 24 h).
Intraoperative and first 24 hours postoperative
Amount of Analgesic required in the first day after surgery
Time Frame: First 24 hours postoperative
The total dose of intravenous (IV) acetaminophen 15 mg/kg if FLACC scores between 2 and 4 at the first 24 h after surgery, and total dose of tramadol 1 mg/kg (IV) in case of FLACC score > 4.
First 24 hours postoperative
Time to first rescue analgesic demand after surgery.
Time Frame: First 24 hours postoperative
measured from the end of surgery till patient require analgesia.
First 24 hours postoperative
Success rate of block
Time Frame: Intraoperative duration
a successful block is defined as absence of significant changes in heart rate following surgical induction. Heart rate increase is not>20% of the basal levels. If the increase is>20%, the block is accepted as unsuccessful.
Intraoperative duration
Duration of performing the block
Time Frame: Intraoperative duration
Block performing time is defined as the period between the insertion of the needle and termination of local anesthetic administration
Intraoperative duration
Incidence of complications
Time Frame: Intraoperative and first 24 hours postoperative
Hypotension, bradycardia, postoperative nausea, vomiting, urinary retention, prolonged motor block, pruritus and local anesthetic systemic toxicity (LAST).
Intraoperative and first 24 hours postoperative

Collaborators and Investigators

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

Sponsor

Tanta 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)

January 16, 2021

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

September 10, 2021

Study Registration Dates

First Submitted

January 11, 2021

First Submitted That Met QC Criteria

January 13, 2021

First Posted (Actual)

January 15, 2021

Study Record Updates

Last Update Posted (Actual)

January 20, 2021

Last Update Submitted That Met QC Criteria

January 16, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 33143/05/19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be available upon reasonable request

IPD Sharing Time Frame

For 1 year after the end of the study

IPD Sharing Access Criteria

The principal investigator will review requests

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

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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