Pericapsular Nerve Group BlockPhase 2NCT06417268
Combined Pericapsular Nerve Group Block and Lateral Femoral Cutaneous Nerve Block for Pediatric Hip Surgeries
A Phase 2 study testing Caudal epidural analgesia, Ultrasound-guided Combined Pericapsular Nerve Group Block and Ultrasound-guided Lateral Femoral Cutaneous Nerve Block in people with Pericapsular Nerve Group Block, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
combined pericapsular nerve group PENG block and lateral femoral cutaneous nerve block may be effective in reducing post-operative pain after open hip surgery in children. Read more about this study
- Who is it for?
- Ages 1 year to 9 years
- Conditions the study is for
- Pericapsular Nerve Group Block
- What is being tested?
- Caudal epidural analgesia, Ultrasound-guided Combined Pericapsular Nerve Group Block and Ultrasound-guided Lateral Femoral Cutaneous Nerve Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2024to 20 Dec 2025
- Phase
- Phase 2
- 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 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I, II.
- Unilateral hip surgery.
Who cannot join
- Parents' refusal to participate in the study.
- Coagulopathy (i.e. Platelets ≤ 50,000 and/or INR> 1.5).
- Localized infection at the site of needle insertion.
- Known hypersensitivity or allergies to any of the used drugs.
- Bilateral hip surgery in the same session.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-Guided Combined Pericapsular Nerve Group Block and Lateral Femoral Cutaneous Nerve Block Versus Caudal Block for Postoperative Analgesia in Pediatric Hip Surgeries. A Randomized Controlled Study.
combined pericapsular nerve group PENG block and lateral femoral cutaneous nerve block may be effective in reducing post-operative pain after open hip surgery in children.
Read the detailed description
All children will be assessed clinically, and investigations will be done to exclude the exclusion criteria mentioned above. Laboratory works needed: complete blood count (CBC), prothrombin time, concentration, partial thromboplastin time. Midazolam (0.5mg/kg) will be given orally to each child in both groups as a premedication half an hour before the procedure.
General anesthesia will be induced in a supine position under standard basic monitoring of vital signs with inhalational anesthetic using (100%) O2 + Sevoflurane.
Group C will receive caudal analgesia Bupivacaine 0.25% at a dose of 1 ml/kg. Group B will receive PENG block Bupivacaine 0.25% at a dose of 1 ml/kg and lateral femoral cutaneous nerve block Bubivacaine 0.25% at 0.1 ml/kg.
After receiving the block, a surgical incision will be done after 15 minutes. Continuous recording of heart rate and blood pressure will be carried out from the moment of injection at timely intervals intra-operative. Intra-operatively, an increase in hemodynamics in response to the skin incision by more than 30% from baseline values 5 min after intubation or thereafter is managed by intravenous administration of fentanyl 1 µg/kg to a maximum dose of 2 µg/kg. Postoperative pain assessment using the FLACC score will then follow for 24 hours.
- Conditions
- Pericapsular Nerve Group Block
- Being tested
- Caudal epidural analgesia, Ultrasound-guided Combined Pericapsular Nerve Group Block, Ultrasound-guided Lateral Femoral Cutaneous Nerve Block, Fentanyl, Morphine
- Keywords
- Hip surgery, Lateral Femoral Cutaneous Nerve Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caudal epidural analgesiaProcedure or surgery
patient will be placed in the left lateral position with flexed hips.After palpating the landmarks (the upper posterior iliac spine and sacral hiatus from the edges of an equilateral triangle), an epidural puncture is 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, the needle is inserted immediately below the spinous process S4.
After perforating the membrane, the needle will be advanced no more than 1-3 mm to avoid a bloody puncture or an intrathecal injection, The confirmation of the correct position of the caudal needle before injection by performing the modified 'swoosh' test" performed by auscultation at the thoracolumbar region with a stethoscope while injecting 2 mL of saline. Bupivacaine 0.25% at a dose of 1 ml/kg will be injected, with care taken not to exceed the maximum recommended dose (2 mg/kg).
Ultrasound-guided Combined Pericapsular Nerve Group BlockProcedure or surgery
With supine position, the probe will be put in a transverse plane along the anterior inferior iliac spine (AIIS) to identify the iliopsoas muscle, femoral nerve, and femoral artery (FA).
Then the probe will be rotated counter clockwise to align with the pubic ramus to visualize the AIIS, iliopsoas prominence (IPE), FA, iliopsoas, and iliopsoas notch.
Under direct vision, a 22-gauge, 50-mm echo needle will be advanced in the lateral-medial plane between the psoas tendon and the pubic ramus until the needle tip touches the IPE. The needle will be withdrawn, and after negative aspiration, 1 ml/kg (Bupivacaine 0.25%) is injected
Ultrasound-guided Lateral Femoral Cutaneous Nerve BlockProcedure or surgery
patient remains supine, and the transducer is parallel to the inguinal ligament. With the femoral artery and vein as guidance, the lateral part of the sartorius muscle and fascia lata is visualized. Approximately 3 cm inferior from this point, the branches of the lateral femoral cutaneous nerve are visualized in the hypoechoic fat-filled subfascial space between the sartorius muscle medially and the tensor fascia lata muscle laterally. A 22-gauge, 50-mm needle is inserted with in plane approach at a shallow angle to reach the area of the nerve and after negative aspiration, 0.1 ml/kg (Bupivacaine 0.25%) is injected.
FentanylDrug
patients will receive an induction dose at 1 mcg/kg. If the analgesia was inadequate in the form of increase in heart rate and or arterial blood pressure by more than 20% of baseline values during surgery, this warrants the administration of intravenous fentanyl (0.5µg/kg).
MorphineDrug
Also called rescue analgesia
If a FLACC pain Score is ≥ 4/10, the patient in the PACU will receive morphine (intravenous, 0.03 mg/kg), and the maximum allowed dose is 0.1mg/kg every 4 hours.
AcetaminophenDrug
P atients will receive postoperative IV acetaminophen IV 10 mg/ kg q 6 hours
| Study group | Role | What they receive |
|---|---|---|
| Group C | Active comparator | Patients will receive caudal analgesia Receives: Procedure: Caudal epidural analgesia; Drug: Fentanyl; Drug: Morphine; Drug: Acetaminophen |
| Group B | Active comparator | patients will receive PENG block and Lateral Femoral Cutaneous Nerve block Receives: Procedure: Ultrasound-guided Combined Pericapsular Nerve Group Block; Procedure: Ultrasound-guided Lateral Femoral Cutaneous Nerve Block; Drug: Fentanyl; Drug: Morphine; Drug: Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first rescue analgesia
Time (minutes) to first need of rescue analgesia postoperative.
Measured: First 24 hours postoperative
Secondary outcomes (5)
Intraoperative hemodynamic parameters
systolic, diastolic, mean blood pressure (mmHg)
Measured: intraoperative period
Intraoperative hemodynamic parameters
heart rate (bpm)
Measured: intraoperative period
Total fentanyl consumption
total intraoperative consumed fentanyl (mg/kg)
Measured: intraoperative period
Total morphine consumption
total postoperative consumed morphine (mg/kg)
Measured: First 24 hours postoperative
Postoperative pain assessment FLACC
In the PACU, quality of analgesia was assessed every 15 minutes for the first hour then after 2, 4 ,6 ,12,18 and 24 hours postoperative using (face, legs, activity, and cry consolability scale) (FLACC) pain score
Measured: First 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start1 Mar 2024
- Primary completion20 Sep 2025
- Study completion20 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pericapsular Nerve Group BlockStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, maged gamal, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06417268
- Sponsor's protocol ID
- MD-16-2024
- Status last verified
- May 2024
- First submitted
- 20 Mar 2024
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Combined Pericapsular Nerve Group Block and Lateral Femoral Cutaneous Nerve Block Versus Caudal Block for Postoperative Analgesia in Pediatric Hip Surgeries. A Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT06417268
- Acronym / sponsor ID
- MD-16-2024
- Conditions
- Pericapsular Nerve Group Block
- Keywords
- Hip surgery, Lateral Femoral Cutaneous Nerve Block
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 20 Sep 2025 (actual)
- Study completion
- 20 Dec 2025 (actual)
- First posted
- 16 May 2024 (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.
combined pericapsular nerve group PENG block and lateral femoral cutaneous nerve block may be effective in reducing post-operative pain after open hip surgery in children.
Detailed description
All children will be assessed clinically, and investigations will be done to exclude the exclusion criteria mentioned above. Laboratory works needed: complete blood count (CBC), prothrombin time, concentration, partial thromboplastin time. Midazolam (0.5mg/kg) will be given orally to each child in both groups as a premedication half an hour before the procedure.
General anesthesia will be induced in a supine position under standard basic monitoring of vital signs with inhalational anesthetic using (100%) O2 + Sevoflurane.
Group C will receive caudal analgesia Bupivacaine 0.25% at a dose of 1 ml/kg. Group B will receive PENG block Bupivacaine 0.25% at a dose of 1 ml/kg and lateral femoral cutaneous nerve block Bubivacaine 0.25% at 0.1 ml/kg.
After receiving the block, a surgical incision will be done after 15 minutes. Continuous recording of heart rate and blood pressure will be carried out from the moment of injection at timely intervals intra-operative. Intra-operatively, an increase in hemodynamics in response to the skin incision by more than 30% from baseline values 5 min after intubation or thereafter is managed by intravenous administration of fentanyl 1 µg/kg to a maximum dose of 2 µg/kg. Postoperative pain assessment using the FLACC score will then follow for 24 hours.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group C | Active comparator | Procedure: Caudal epidural analgesia, Drug: Fentanyl, Drug: Morphine, Drug: AcetaminophenPatients will receive caudal analgesia |
| Group B | Active comparator | Procedure: Ultrasound-guided Combined Pericapsular Nerve Group Block, Procedure: Ultrasound-guided Lateral Femoral Cutaneous Nerve Block, Drug: Fentanyl, Drug: Morphine, Drug: Acetaminophenpatients will receive PENG block and Lateral Femoral Cutaneous Nerve block |
Who may qualify
- Ages
- 1 year to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical status I, II.
- Unilateral hip surgery.
Key exclusion criteria (5 listed)
- Parents' refusal to participate in the study.
- Coagulopathy (i.e. Platelets ≤ 50,000 and/or INR> 1.5).
- Localized infection at the site of needle insertion.
- Known hypersensitivity or allergies to any of the used drugs.
- Bilateral hip surgery in the same session.
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 |
|---|---|---|
| Caudal epidural analgesiapatient will be placed in the left lateral position with flexed hips.After palpating the landmarks (the upper posterior iliac spine and sacral hiatus from the edges of an equilateral triangle), an epidural puncture is 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, the needle is inserted immediately below the spinous process S4. After perforating the membrane, the needle will be advanced no more than 1-3 mm to avoid a bloody puncture or an intrathecal injection, The confirmation of the correct position of the caudal needle before injection by performing the modified 'swoosh' test" performed by auscultation at the thoracolumbar region with a stethoscope while injecting 2 mL of saline. Bupivacaine 0.25% at a dose of 1 ml/kg will be injected, with care taken not to exceed the maximum recommended dose (2 mg/kg). | Procedure or surgery | Group C |
| Ultrasound-guided Combined Pericapsular Nerve Group BlockWith supine position, the probe will be put in a transverse plane along the anterior inferior iliac spine (AIIS) to identify the iliopsoas muscle, femoral nerve, and femoral artery (FA). Then the probe will be rotated counter clockwise to align with the pubic ramus to visualize the AIIS, iliopsoas prominence (IPE), FA, iliopsoas, and iliopsoas notch. Under direct vision, a 22-gauge, 50-mm echo needle will be advanced in the lateral-medial plane between the psoas tendon and the pubic ramus until the needle tip touches the IPE. The needle will be withdrawn, and after negative aspiration, 1 ml/kg (Bupivacaine 0.25%) is injected | Procedure or surgery | Group B |
| Ultrasound-guided Lateral Femoral Cutaneous Nerve Blockpatient remains supine, and the transducer is parallel to the inguinal ligament. With the femoral artery and vein as guidance, the lateral part of the sartorius muscle and fascia lata is visualized. Approximately 3 cm inferior from this point, the branches of the lateral femoral cutaneous nerve are visualized in the hypoechoic fat-filled subfascial space between the sartorius muscle medially and the tensor fascia lata muscle laterally. A 22-gauge, 50-mm needle is inserted with in plane approach at a shallow angle to reach the area of the nerve and after negative aspiration, 0.1 ml/kg (Bupivacaine 0.25%) is injected. | Procedure or surgery | Group B |
| Fentanylpatients will receive an induction dose at 1 mcg/kg. If the analgesia was inadequate in the form of increase in heart rate and or arterial blood pressure by more than 20% of baseline values during surgery, this warrants the administration of intravenous fentanyl (0.5µg/kg). | Drug | Group B, Group C |
| MorphineAlso: rescue analgesiaIf a FLACC pain Score is ≥ 4/10, the patient in the PACU will receive morphine (intravenous, 0.03 mg/kg), and the maximum allowed dose is 0.1mg/kg every 4 hours. | Drug | Group B, Group C |
| AcetaminophenP atients will receive postoperative IV acetaminophen IV 10 mg/ kg q 6 hours | Drug | Group B, Group C |
Primary outcome
Time to first rescue analgesia
Time frame: First 24 hours postoperative
Time (minutes) to first need of rescue analgesia postoperative.
5 secondary outcomes
Intraoperative hemodynamic parameters
Time frame: intraoperative period
Intraoperative hemodynamic parameters
Time frame: intraoperative period
Total fentanyl consumption
Time frame: intraoperative period
Total morphine consumption
Time frame: First 24 hours postoperative
Postoperative pain assessment FLACC
Time frame: First 24 hours postoperative
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 16 Jun 2026.
- Individual participant dataSharing planned: No
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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 Phase 2 study testing Caudal epidural analgesia, Ultrasound-guided Combined Pericapsular Nerve Group Block and Ultrasound-guided Lateral Femoral Cutaneous Nerve Block in people with Pericapsular Nerve Group Block, run by Kasr El Aini Hospital 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 2 inclusion and 5 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 16 Jun 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time to first rescue analgesia (time frame: 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 16 Jun 2026.