NCT07056946

Brief Summary

patients will then be randomized in the two groups.

  1. 1.Group C: in this group children will receive US-guided caudal analgesia (CA) after GA. The caudal block will be performed
  2. 2.Group B: in this group children will receive lower limb peripheral nerve blocks in the form of US-guided fascia iliaca Block.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress84%
Aug 2025Jul 2026

First Submitted

Initial submission to the registry

June 29, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 9, 2025

Completed
23 days until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

July 15, 2025

Status Verified

July 1, 2025

Enrollment Period

11 months

First QC Date

June 29, 2025

Last Update Submit

July 14, 2025

Conditions

Keywords

Supra inguinal fascia iliaca Block ,Caudal Analgesia,Pediatrics

Outcome Measures

Primary Outcomes (1)

  • • Estimation of time of first rescue postoperative analgesia

    4 hours postoperatively

Study Arms (2)

Group C: in this group children will receive US-guided caudal analgesia (CA) after GA.

ACTIVE COMPARATOR

The caudal block will be performed by visualizing the sacral hiatus at the level of the sacral cornu after placing the probe transversely obtaining a short axis view

Other: Caudal Block Anesthesia

Group B: in this group children will receive lower limb peripheral nerve blocks in the form of US

EXPERIMENTAL

With the patient in the proper position, the skin is disinfected and the transducer positioned to identify the femoral artery and the iliopsoas muscle and fascia iliaca. The transducer is moved laterally until the sartorius muscle is identified. After a skin wheal is made, the needle is inserted in-plane

Other: Fascia Iliaca Nerve Block

Interventions

With the patient in the proper position, the skin is disinfected and the transducer positioned to identify the femoral artery and the iliopsoas muscle and fascia iliaca. The transducer is moved laterally until the sartorius muscle is identified. After a skin wheal is made, the needle is inserted in-plane

Group B: in this group children will receive lower limb peripheral nerve blocks in the form of US

The caudal block will be performed by visualizing the sacral hiatus at the level of the sacral cornu after placing the probe transversely obtaining a short axis view, two hyperechoic lines will appear between the sacral cornu the superficial line is the sacrococcygeal ligament

Group C: in this group children will receive US-guided caudal analgesia (CA) after GA.

Eligibility Criteria

Age1 Year - 18 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 1-12 years
  • scheduled for anterior and lateral thigh Surgeries
  • American Society of Anesthesiologists (ASA) physical status II or III

You may not qualify if:

  • Refusal of parental consent
  • Allergy to any local anesthetics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer institute

Cairo, Egypt

Location

MeSH Terms

Conditions

Bone Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBone DiseasesMusculoskeletal Diseases

Central Study Contacts

suzan Adlan Adlan, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

June 29, 2025

First Posted

July 9, 2025

Study Start

August 1, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

July 15, 2025

Record last verified: 2025-07

Locations