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Regional Anesthesia MorbidityNCT07137962

Pericapsular Nerve Group Block vs. Fascia Iliaca Compartment Block vs. Caudal Block for Hip Surgeries

A study testing PENG Block, FICB Block and Caudal Block in people with Regional Anesthesia Morbidity and Hip Surgeries, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 year to 6 yearsHealthy volunteers can take part
What is being tested?
PENG Block, FICB Block and Caudal Block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
1 Oct 2024to 1 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 6 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Cairo university Hospitals. kasralainy

    Cairo

Other trials in Egypt

About this study

Official title: Comparison Between Pericapsular Nerve Group Block Versus Fascia Iliaca Compartment Block Versus Caudal Block for Postoperative Analgesia in Hip Surgeries in Children, A Randomized Controlled Clinical Trial

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.

Read the detailed description

Study included ASA I, II,1-6 years old from both sexes, scheduled for elective hip surgery.while exclusion criteria include 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).

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:

Group A: patients received pericapsular nerve block group (PENG) block with 0.25% bupivacaine 0.5 ml/kg.

Group B: patients received fascia iliaca compartment block (FICB) with 0.25% bupivacaine 0.5 ml/kg.

Group C: patients received caudal block with 0.25% bupivacaine 1 ml/kg. On the day before the surgery, pre-operative assessment was performed, Medical and surgical history were taken, examination (airway to exclude difficult airway, chest, back, abdomen, and limbs to exclude infection at injection site and anatomical deformities) was performed.

Standard monitoring devices such as ECG, non-invasive blood pressure, pulse oximeter, and capnography were applied. Baseline blood pressure and heart rate were recorded.

General anesthesia was induced using inhalational induction with 8% sevoflurane and 50% oxygen administered via a face mask. intravenous cannula 20G was subsequently placed. fentanyl (1 mcg/kg) was given. Intubation was facilitated by atracurium (0.5 mg/kg), and then an appropriately sized endotracheal tube was placed.

All patients were mechanically ventilated with a targeted Et CO2 of 30-35 mmHg. Anesthesia was maintained with Isoflurane 1.2 % (1 MAC) to 1.5 %, depending on hemodynamics of the patient) in a mixture of 50% air and oxygen throughout the procedure. Another IV cannula was secured as per our standard protocol.

Intraoperative hypothermia was prevented by operating table mattress or operating room heater and warm intravenous fluids (15 mL/kg lactated ringer solution in the first hour, then completed according to the 4: 2: 1 rule: 4 mL/kg/h for the first 10 kg of weight, 2 mL/kg/h for the second 10 kg, and 1 mL/kg/h for each remaining kilogram). Replacement of losses: blood loss was replaced by non-glucose crystalloids in a ratio of 3: 1. It was replaced by packed RBCs guided by serum hemoglobin.

Nerve blocks were performed following anesthesia induction and before initiation of surgery, the patient was placed in a supine position, The region was then swabbed in a craniocaudal direction with a 70% alcohol solution. Intensive disinfection with alcoholic solution, sterile drapes, and the use of sterile gloves is standard for all regional blockades, all blocks were performed by an experienced anesthesiologist who was otherwise not involved in the study. The ultrasound machine used Sonosite S-Nerve Ultrasound System with linear probe, frequency: 6-15 MHz.

PENG Block:

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.

FICB block:

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.

Caudal Block:

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. Intensive disinfection with alcoholic solution, sterile drapes, and the use of sterile gloves is standard for all neuraxial blockades at our institution.

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, 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 to exceed the maximum recommended dose (2 mg/kg).

In all groups, hemodynamic parameters (non-invasive arterial blood pressure (mean, systolic, and diastolic), heart rate, and oxygen saturation) were recorded at baseline, 5 minutes after intubation, and every 10 minutes till the end of the surgery. Skin incisions were allowed 10 minutes after performing the block.

Failed blocks (increase in HR and mean arterial pressure (MAP) >20% from the baseline with skin incision) were treated with 1 mcg/kg of fentanyl. Patients with failed block were excluded from the study.

If hypotension occurred (defined as a decrease in mean arterial pressure (MAP) >30% from baseline value), patients were treated with 0.3 - 1.2 mg / kg ephedrine until hypotension is resolved. If bradycardia occurred (defined as a decrease in HR > 30% from baseline readings), it was treated with atropine 0.02 mg/kg IV.

After skin closure, inhalational anesthesia was discontinued, and reversal of muscle relaxation was achieved with atropine (0.02 mg/kg) and neostigmine (0.05 mg/kg).

after the return of the patient's spontaneous breathing. The patient was extubated fully awake (opening the eyes). Patients were then transferred to the post-anesthesia care unit (PACU) for 60 minutes for monitoring.

In PACU, vital signs (heart rate, arterial blood pressure, and oxygen saturation) were assessed every 10 minutes. After discharging the patient from the PACU, the analgesic plan was IV paracetamol (15 mg/kg) every 8 hours.

Face, Legs, Activity, Cry, and Consolability (FLACC) pain scale was recorded every 2 h in the first 8 h, then every 4 h till 24 h postoperative. Rescue analgesia is in the form of IV morphine 0.05 mg/kg was given as rescue analgesia if the FLACC Score was ≥ 4 (Table 1) (26).

Maximal daily morphine didn't exceed 0.3 mg/kg. Time to first rescue analgesia was recorded.

Measurement Data : Patient's characteristics include age in years, weight in kilograms, gender, and type of surgery, Hemodynamic parameters (non-invasive arterial blood pressure, heart rate, and oxygen saturation) were recorded at baseline, 5 minutes after intubation, every 10 minutes till the end of the surgery, immediately after extubation, and every 10 minutes in PACU for 1 hour till the discharge of the patient, Total opioid consumption in the first 24 hours postoperative., FLACC Pain Scale every 2 h in the first 8 h, then every 4 h till 24 h postoperative, Time for first rescue analgesia in the first 24 hours postoperative ,Intraoperative total opioid consumption, Incidence of postoperative nausea and vomiting in the first 24 hours and Incidence of complications (bradycardia, hypotension, respiratory depression)

Being tested
PENG Block, FICB Block, Caudal Block
Keywords
PENG block, Caudal block, FICB, Pediatrics, Hip Surgeries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PENG BlockProcedure or surgery

    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.

  • FICB BlockProcedure or surgery

    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.

  • Caudal BlockProcedure or surgery

    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.

Study groups in NCT07137962
Study groupRoleWhat they receive
Group A: PENG BlockActive comparatorThe 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.
Receives: Procedure: PENG Block
Group B: FICB blockActive comparatorThe 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.
Receives: Procedure: FICB Block
Group C:Caudal BlockActive comparatorThe 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).
Receives: Procedure: Caudal Block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total opioid consumption

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

    Measured: The first 24 hours postoperative.

Secondary outcomes (5)
  1. FLACC Pain Scale

    FLACC Pain Scale every 2 h in the first 8 h, then every 4 h till 24 h postoperative,

    Measured: 24 hours

  2. Time for first rescue analgesia

    Time (hr) for first rescue analgesia in the first 24 hours post-operative

    Measured: 24 hours

  3. Total opioid consumption

    Intra-operative total opioid (fentanyl) (mcg/kg) consumption

    Measured: time of operation up to 6 hours

  4. Postoperative nausea and vomiting

    Incidence of postoperative nausea and vomiting in first 24 hours

    Measured: 24 hours

  5. Incidence of complications

    Incidence of complications (bradycardia, hypotension, respiratory depression as bradypnea or hypoxia in PACU).

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2025
  2. Study start1 Oct 2024
  3. Primary completion1 Mar 2025
  4. Study completion1 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07137962
Sponsor's protocol ID
MS-441- 2024
Status last verified
Aug 2025
First submitted
15 Aug 2025
Last updated
22 Aug 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing PENG Block, FICB Block and Caudal Block in people with Regional Anesthesia Morbidity and Hip Surgeries, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total opioid consumption (time frame: The first 24 hours postoperative.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.

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