NCT07137962

Brief Summary

The study aims to compare the effect of pericapsular nerve group block versus fascia iliaca compartment block versus caudal block regarding Postoperative analgesia in children undergoing hip surgeries.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

October 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 22, 2025

Completed
Last Updated

August 22, 2025

Status Verified

August 1, 2025

Enrollment Period

5 months

First QC Date

August 15, 2025

Last Update Submit

August 21, 2025

Conditions

Keywords

PENG blockCaudal blockFICBPediatricsHip Surgeries

Outcome Measures

Primary Outcomes (1)

  • Total opioid consumption

    Total opioid (morphine) (mg) consumption in the first 24 hours postoperative.

    The first 24 hours postoperative.

Secondary Outcomes (5)

  • FLACC Pain Scale

    24 hours

  • Time for first rescue analgesia

    24 hours

  • Total opioid consumption

    time of operation up to 6 hours

  • Postoperative nausea and vomiting

    24 hours

  • Incidence of complications

    24 hours

Study Arms (3)

Group A: PENG Block

ACTIVE COMPARATOR

The curvilinear low-frequency (2-5 MHz) ultrasound probe was placed over the line parallel to the inguinal ligament. It was subsequently rotated 45° to identify the anterior inferior iliac spine, the ilio-pubic eminence, and the psoas tendon. A needle was inserted in the plane to place the tip in the musculo-fascial plane between the pubic ramus posteriorly and the psoas tendon anteriorly, using the hydro-dissection technique. Following negative aspiration, a total volume of 0.5 ml/kg of 0.25% bupivacaine was injected.

Procedure: PENG Block

Group B: FICB block

ACTIVE COMPARATOR

The linear ultrasound probe was placed over the inguinal ligament in the sagittal plane, inferomedial to the anterior superior iliac spine. Upon identifying the "bow-tie sign" formed by the sartorius muscle and the internal oblique muscle by sliding medially and rotating the probe. 22-gauge echogenic needle was introduced 1 cm cephalad to the inguinal ligament to place the needle tip in the space between the internal oblique and iliacus muscles, using the hydro-dissection technique. A total volume of 0.5 mL/kg of bupivacaine 0.25% was injected following negative aspiration.

Procedure: FICB Block

Group C:Caudal Block

ACTIVE COMPARATOR

The patient was placed in the left lateral position with the upper hip flexed at 90° and the lower hip flexed at 45°. The region was then swabbed in a craniocaudal direction with 70% alcohol. After palpating the landmarks (the upper posterior iliac spine and sacral hiatus from the edges of an equilateral triangle), an epidural puncture was performed in the most proximal region of the sacral hiatus with the needle inclined 45-60° to the skin. While palpating with the index finger of the left hand, a needle was inserted immediately below the spinous process S4. After perforating the membrane, which occludes the sacral hiatus, the needle was advanced no more than 1-3 mm to avoid a bloody puncture or an intrathecal injection. Bupivacaine 0.25% at a dose of 1 ml/kg was injected, with care taken to not exceed the maximum recommended dose (2 mg/kg).

Procedure: Caudal Block

Interventions

PENG BlockPROCEDURE

The curvilinear low-frequency (2-5 MHz) ultrasound probe was placed over the line parallel to the inguinal ligament. It was subsequently rotated 45° to identify the anterior inferior iliac spine, the ilio-pubic eminence, and the psoas tendon. A 22-gauge echogenic needle was inserted in plain to place the tip in musculo-fascial plain between pubic ramus posteriorly and psoas tendon anteriorly, using hydro-dissection technique. Following negative aspiration, a total volume of 0.5 ml/kg of 0.25% bupivacaine was injected.

Group A: PENG Block
FICB BlockPROCEDURE

The linear ultrasound probe was placed over the inguinal ligament in the sagittal plane, inferomedial to the anterior superior iliac spine. Upon identifying the "bow-tie sign" formed by the sartorius muscle and the internal oblique muscle by sliding medially and rotating the probe. 22-gauge echogenic needle was introduced 1 cm cephalad to the inguinal ligament to place the needle tip in the space between the internal oblique and iliacus muscles, using the hydro-dissection technique. A total volume of 0.5 mL/kg of bupivacaine 0.25% was injected following negative aspiration.

Group B: FICB block
Caudal BlockPROCEDURE

After induction of general anesthesia, the patient was placed in the left lateral position with the upper hip flexed at 90° and the lower hip flexed at 45°. The region was then swabbed in a craniocaudal direction with a 70% alcohol solution. After palpating the landmarks (the upper posterior iliac spine and sacral hiatus from the edges of an equilateral triangle), an epidural puncture was performed in the most proximal region of the sacral hiatus with the needle inclined 45-60° to the skin. While palpating with the index finger of the left hand, a needle was inserted immediately below the spinous process S4. After perforating the membrane, which occludes the sacral hiatus, the needle was advanced no more than 1-3 mm to avoid a bloody puncture or an intrathecal injection. Bupivacaine 0.25% at a dose of 1 ml/kg was injected.

Group C:Caudal Block

Eligibility Criteria

Age1 Year - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • ASA I, II,1-6 years old from both sexes, scheduled for elective hip surgery.

You may not qualify if:

  • ASA III and IV, Allergy to any medication used, neurological or psychological disorders, anatomic abnormalities or infection at site of injection and bleeding disorders (international normalized ratio (INR) \>1.5 and/or platelet count \<100,000/µL).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university Hospitals. kasralainy

Cairo, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Computer-generated randomization numbers were used for random allocation and each patients' code was kept in an opaque sealed envelope. Patients were randomly allocated with 1:1:1 allocation ratio into three groups in a parallel manner.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Nerve blocks were performed following anesthesia induction and before initiation of surgery, the patient was placed in a supine position according to study group include PENG Block, FICB and caudal Block.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anesthesia ,SICU and pain

Study Record Dates

First Submitted

August 15, 2025

First Posted

August 22, 2025

Study Start

October 1, 2024

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

August 22, 2025

Record last verified: 2025-08

Locations