Ultrasound-Guided Lumbar Erector Spinae Plane Block Versus Caudal Block for Postoperative Analgesia in Hip and Proximal Femur Surgery in Pediatric Patients

Ultrasound-Guided Lumbar Erector Spinae Plane Block Versus Caudal Block for Postoperative Analgesia in Hip and Proximal Femur Surgery in Pediatric Patients: A Prospective Randomized Controlled Study

The study will compare Ultrasound-Guided Lumbar Erector Spinae Plane Block and caudal block for Postoperative Analgesia in Hip and Proximal Femur Surgery in pediatric patients

Study Overview

• Status: Completed
• Conditions: Post Operative Pain
• Intervention / Treatment: Procedure: erector spinea block; Procedure: Caudal epidural block

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Kasr Alaini hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA I-II.
• Scheduled to undergo hip or proximal femur surgeries.

Exclusion Criteria:

• Refusal of participation by parents or caregivers
• Known local anesthetic (LA) drug sensitivity
• Bleeding disorders with INR > 1.5 and/or platelets < 100,000/mm3.
• Skin lesions or wounds at the site of proposed needle insertion.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group ESPB; Erector Spinae Plane Block	Procedure: erector spinea block; the patients will receive a single injection erector spinea block after induction of general anesthesia
Active Comparator: In group CEA; Caudal epidural block	Procedure: Caudal epidural block; the patients will receive caudal epidural block after induction of general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score	By using face, legs, activity, and cry consolability scale [FLACC ] FLACC scale will be measured as following: Each category (face,legs,activity, and cry consolability) is scored on the 0-2 scale which results in a total score of 0-10. Assessment of the final score: 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain	2 hours post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain scores	By using face, legs, activity, and cry consolability scale [FLACC ] FLACC scale will be measured as following: Each category (face,legs,activity, and cry consolability) is scored on the 0-2 scale which results in a total score of 0-10. Assessment of the final score: 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain	at 2 hour intervals during the first 24 hours postoperatively
Block failure rate	The block will be considered a failed block if the patient required more than two doses of rescue analgesia in the first hour postoperatively	First hour postoperatively
Block performance time		Preoperative
The incidence of adverse effects		Up to one week after the block
Duration of the block		UP to 48 hours postoperatively
Degree of contralateral motor blockage and lower limb weakness	By using modified bromage scale as following: Grade I : Free movement of legs and feet Degree of block :Nil (0%) Grade II :Just able to flex knees with free movement of feet Degree of block :Partial (33%) Grade III :Unable to flex knees, but with free movement of feet Degree of block: Almost complete (66%) Grade IV :Unable to move legs or feet Degree of block: Complete (100%)	UP to 48 hours postoperatively

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2021
• Primary Completion (Actual): June 2, 2022
• Study Completion (Actual): June 28, 2022

Study Registration Dates

• First Submitted: September 28, 2021
• First Submitted That Met QC Criteria: December 1, 2021
• First Posted (Actual): December 15, 2021

Study Record Updates

• Last Update Posted (Actual): July 18, 2022
• Last Update Submitted That Met QC Criteria: July 15, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: MD-340-2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No