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

Cairo University1 site in 1 country76 target enrollmentDecember 21, 2021

ConditionsPost Operative Pain

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Post Operative Pain
Sponsor: Cairo University
Enrollment: 76
Locations: 1
Primary Endpoint: Pain score
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

December 21, 2021

End Date

June 28, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Cairo University

Responsible Party

Principal Investigator

AbdElKhalik Mahmoud Shaban

Lecturer of anaesthesia

Cairo University

Eligibility Criteria

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/mm
•Skin lesions or wounds at the site of proposed needle insertion.

Outcomes

Primary Outcomes

Pain score

Time Frame: 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 Outcomes

Block failure rate(First hour postoperatively)
pain scores(at 2 hour intervals during the first 24 hours postoperatively)
Duration of the block(UP to 48 hours postoperatively)
Degree of contralateral motor blockage and lower limb weakness(UP to 48 hours postoperatively)
Block performance time(Preoperative)
The incidence of adverse effects(Up to one week after the block)