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.
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
- Conditions the study is for
- Regional Anesthesia Morbidity, Hip Surgeries, Perioperative Analgesia
- What is being tested?
- PENG Block, FICB Block and Caudal Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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.
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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). Receives: Procedure: Caudal Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total opioid consumption
Total opioid (morphine) (mg) consumption in the first 24 hours postoperative.
Measured: The first 24 hours postoperative.
Secondary outcomes (5)
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
Time for first rescue analgesia
Time (hr) for first rescue analgesia in the first 24 hours post-operative
Measured: 24 hours
Total opioid consumption
Intra-operative total opioid (fentanyl) (mcg/kg) consumption
Measured: time of operation up to 6 hours
Postoperative nausea and vomiting
Incidence of postoperative nausea and vomiting in first 24 hours
Measured: 24 hours
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.
- First posted22 Aug 2025
- Study start1 Oct 2024
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regional Anesthesia MorbidityStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nagy Malak , MD, Cairo University
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07137962
- Acronym / sponsor ID
- MS-441- 2024
- Keywords
- PENG block, Caudal block, FICB, Pediatrics, Hip Surgeries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group A: PENG Block | Active comparator | Procedure: PENG BlockThe 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. |
| Group B: FICB block | Active comparator | Procedure: FICB BlockThe 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 C:Caudal Block | Active comparator | Procedure: Caudal BlockThe 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). |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- ASA I, II,1-6 years old from both sexes, scheduled for elective hip surgery.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PENG BlockThe 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. | Procedure or surgery | Group A: PENG Block |
| FICB BlockThe 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 or surgery | Group B: FICB block |
| Caudal BlockAfter 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. | Procedure or surgery | Group C:Caudal Block |
Primary outcome
Total opioid consumption
Time frame: The first 24 hours postoperative.
Total opioid (morphine) (mg) consumption in the first 24 hours postoperative.
5 secondary outcomes
FLACC Pain Scale
Time frame: 24 hours
Time for first rescue analgesia
Time frame: 24 hours
Total opioid consumption
Time frame: time of operation up to 6 hours
Postoperative nausea and vomiting
Time frame: 24 hours
Incidence of complications
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
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Mastectomy; Lymphedema, Chronic Pain
Active, not recruitingObservational study
Retrospective Analysis of Pain After Nerve Block in Surgical Patients
Regional Anesthesia Morbidity, Acute Pain
Recruiting
Pericapsular Nerve Group (PENG) Block Combined With Lateral Femoral Cutaneous Nerve (LFCN) Block or Wound Infiltration for Postoperative Analgesia in Anterior Approach Total Hip Arthroplasty: A Randomized Controlled Trial
Arthropathy of Hip, Hip Arthropathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.