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

Phase 3

Completed

• Conditions: Post Operative Pain
• Interventions: Procedure: Caudal epidural block; Procedure: erector spinea block

• Registration Number: NCT05157516
• Lead Sponsor: Cairo University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-28
• Study First Submitted QC: 2021-12-01
• Study First Posted: 2021-12-15
• Study Start: 2021-12-21
• Primary Completion: 2022-06-02
• Study Completion: 2022-06-28
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-15
• Last Update Posted: 2022-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
In group CEA	Caudal epidural block	Caudal epidural block
group ESPB	erector spinea block	Erector Spinae Plane Block

Primary Outcome Measures

Name	Time	Method
Pain score	2 hours post-operatively	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

Secondary Outcome Measures

Name	Time	Method
Block performance time	Preoperative
Block failure rate	First hour postoperatively	The block will be considered a failed block if the patient required more than two doses of rescue analgesia in the first hour postoperatively
pain scores	at 2 hour intervals during the first 24 hours postoperatively	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
Duration of the block	UP to 48 hours postoperatively
Degree of contralateral motor blockage and lower limb weakness	UP to 48 hours postoperatively	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%)
The incidence of adverse effects	Up to one week after the block

Trial Locations

Locations (1)

Kasr Alaini hospital; 🇪🇬 Cairo, Egypt