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

NCT05157516 | Completed Phase 3

• 1 other identifier: MD-340-2020
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• pain scores

  at 2 hour intervals during the first 24 hours postoperatively

• Block failure rate

  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

Study Arms (2)

group ESPB

ACTIVE COMPARATOR

Erector Spinae Plane Block

Procedure: erector spinea block

In group CEA

ACTIVE COMPARATOR

Caudal epidural block

Procedure: Caudal epidural block

Interventions

erector spinea block PROCEDURE

the patients will receive a single injection erector spinea block after induction of general anesthesia

group ESPB

Caudal epidural block PROCEDURE

the patients will receive caudal epidural block after induction of general anesthesia

In group CEA

Eligibility Criteria

• Age: 1 Year - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alaini hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anaesthesia

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: December 15, 2021
• Study Start: December 21, 2021
• Primary Completion: June 2, 2022
• Study Completion: June 28, 2022
• Last Updated: July 18, 2022

Record last verified: 2022-07

Locations

EG (1)