Pain, PostoperativeNCT06563622
Pericapsular Nerve Group Block Versus Caudal Block for Postoperative Pain Management in Pediatric Hip Surgery
A study testing Pericapsular Nerves Group Block and Caudal Epidural Block in people with Pain, Postoperative, run by Benha University at 1 site in Egypt.
Trial summary
Children can experience substantial pain after hip operations, causing agitation, depression, and sleep disruption, which can have a negative impact on their health. Opioids are associated with several serious side effects that limits its use as solo agents for pain management. Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Pericapsular Nerves Group Block and Caudal Epidural Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2024to 20 Apr 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 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- child aged 1- 7 years old
- American Society of Anesthesiologists (ASA) physical status I-II
- scheduled for elective hip surgery under general anesthesia
Who cannot join
- parents/guardians refusal to participate
- known local anesthetic drug sensitivity,
- bleeding disorders,
- pre-existing infection at the block site, and
- the presence of major cardiac, renal, or hepatic disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-Guided Pericapsular Nerve Group Block Versus Ultrasound-Guided Caudal Block for Postoperative Pain Management in Pediatric Hip Surgery; a Randomized Controlled Trail
Children can experience substantial pain after hip operations, causing agitation, depression, and sleep disruption, which can have a negative impact on their health. Opioids are associated with several serious side effects that limits its use as solo agents for pain management. Regional blocks such as caudal Block (CB) and pericapsular nerve group (PENG) block in adjuvant with general anaesthesia are alternative perioperative analgesic techniques that lead to lesser side effects, including motor weakness, postoperative nausea and vomiting with decreased opioid consumption.
Read the detailed description
Regional anesthesia is often used to prevent postoperative pain in pediatric surgery. Combined with general anesthesia (GA), ultrasound (US)-guided regional anesthetic approaches provide simple intraoperative pathway that reduced GA requirements, lower pain score with less impact on the respiratory or cardiovascular system
In pediatric surgery, caudal block (CB) is a low-cost, simple, and effective procedure for postoperative analgesia. CB is suggested for most surgeries in the lower body, primarily below the umbilicus. Although the well-established anesthetic properties of CB, its action terminates early in the postoperative period and it has a number of restrictions, such as anatomical abnormalities or infection at the injection site, that can prevent its use
PENG block is the plane lying between the psoas muscle and tendon and the ilio-pubic eminence. The single-shot PENG block has lately been reported in the cadaveric study and in the literature for perioperative pain management in hip surgery by aiming the articular arms of the accessory obturator nerve (AON), femoral nerve (FN), and obturator nerve (ON). The technical simplicity of imaging in traction-fixed patients and no need for multiple punctures made this blockage ideal for young pediatric patients. Unfortunately, there are no adequate studies regarding PENG block in patients younger than five years old.
This study was carried out to assess ultrasound-guided PENG block versus CB for their efficacy, safety and pain management in pediatric hip surgery.
- Conditions
- Pain, Postoperative
- Being tested
- Pericapsular Nerves Group Block, Caudal Epidural Block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pericapsular Nerves Group BlockProcedure or surgery
Also called PENG Block
USG-guided single-shot PENG in a dose of 0.5 ml/kg of 0.25% bupivacaine per side.
Caudal Epidural BlockProcedure or surgery
Also called CEB
USG-guided single-shot CEB in a dose of 0.5 mL/kg of 0.25% bupivacaine.
| Study group | Role | What they receive |
|---|---|---|
| Group P | Experimental | In ultrasound-guided pericapsular nerve group block Group , the patient will be positioned in a supine position. The anatomical landmarks, including ilio-pubic eminence, the iliopsoas muscle and tendon, the femoral artery and vein, and the pectineus muscle, will be identified using a 9-12 MHz superficial linear transducer. A lateral to medial in-plane technique will be used to insert a 22-gauge, 50-mm needle. the needle's tip will be positioned at the musculofascial plane, located between the ilio-pubic ramus posteriorly and the psoas tendon anteriorly. Following negative aspiration to avoid intravascular injection, 0.5-1 ml of normal saline will be injected to confirm the correct needle site. A 0.5 ml/kg plain bupivacaine 0.25% will be injected. Receives: Procedure: Pericapsular Nerves Group Block |
| Group C | Active comparator | the caudal epidural block will be established in the lateral decubitus position, the high-frequency linear transducer will be first placed transversely at the midline to obtain a "frog eye" sign view of the sacral cornu, the sacro-coccygeal ligament, the sacrum, and the sacral hiatus. At this position, the USG transducer will be rotated by 90° to obtain a longitudinal view. The needle will be inserted in-plane into the sacral canal and the Local anaesthetics will be injected under real-time visualization by a dose of 0.5 ml/kg plain bupivacaine 0.25%. Receives: Procedure: Caudal Epidural Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score with FLACC
(Face, Legs, Activity, Cry, and Consolability scale to assess pain in young children. Each category is scored on a 0-2 scale which results in a total score between 0 (lowest pain) and 10 (worst pain).
Measured: 30 minutes postoperative, 1 hour postoperative, 2 hour postoperative, and 6 hours postoperative
Secondary outcomes (5)
The duration of the block
from immediately after the block administration until the first postoperative rescue analgesia.
Measured: immediately after the intervention, up to 24 hours postoperative
the Time to first postoperative rescue analgesia
it will be administered if the FLACC score is ≥ 4/10.
Measured: 24 hours postoperative
Total rescue analgesia consumption
total dose of Morphine administrated as rescue opioid
Measured: 24 hours postoperative
The incidence of postoperative adverse effects
including nausea , vomiting , localized hematoma, bradycardia, hypo-tension, and Pruritis.
Measured: 24 hours postoperative
Parents satisfaction score
using a 5- point Likert score (0 = very dissatisfied, 1=dissatisfied, 2 = neither satisfied nor dissatisfied, 3 = satisfied and 4 = very satisfied)
Measured: 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 posted21 Aug 2024
- Study start10 Aug 2024
- Primary completion1 Apr 2025
- Study completion20 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Rafik Mohamed Amin, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06563622
- Sponsor's protocol ID
- RC.30.9.2023
- Status last verified
- Nov 2025
- First submitted
- 13 Aug 2024
- Last updated
- 28 Nov 2025
- Results posted
- 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 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Pericapsular Nerve Group Block Versus Ultrasound-Guided Caudal Block for Postoperative Pain Management in Pediatric Hip Surgery; a Randomized Controlled Trail
- ClinicalTrials.gov ID
- NCT06563622
- Acronym / sponsor ID
- RC.30.9.2023
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 10 Aug 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 20 Apr 2025 (actual)
- First posted
- 21 Aug 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.
Children can experience substantial pain after hip operations, causing agitation, depression, and sleep disruption, which can have a negative impact on their health. Opioids are associated with several serious side effects that limits its use as solo agents for pain management. Regional blocks such as caudal Block (CB) and pericapsular nerve group (PENG) block in adjuvant with general anaesthesia are alternative perioperative analgesic techniques that lead to lesser side effects, including motor weakness, postoperative nausea and vomiting with decreased opioid consumption.
Detailed description
Regional anesthesia is often used to prevent postoperative pain in pediatric surgery. Combined with general anesthesia (GA), ultrasound (US)-guided regional anesthetic approaches provide simple intraoperative pathway that reduced GA requirements, lower pain score with less impact on the respiratory or cardiovascular system
In pediatric surgery, caudal block (CB) is a low-cost, simple, and effective procedure for postoperative analgesia. CB is suggested for most surgeries in the lower body, primarily below the umbilicus. Although the well-established anesthetic properties of CB, its action terminates early in the postoperative period and it has a number of restrictions, such as anatomical abnormalities or infection at the injection site, that can prevent its use
PENG block is the plane lying between the psoas muscle and tendon and the ilio-pubic eminence. The single-shot PENG block has lately been reported in the cadaveric study and in the literature for perioperative pain management in hip surgery by aiming the articular arms of the accessory obturator nerve (AON), femoral nerve (FN), and obturator nerve (ON). The technical simplicity of imaging in traction-fixed patients and no need for multiple punctures made this blockage ideal for young pediatric patients. Unfortunately, there are no adequate studies regarding PENG block in patients younger than five years old.
This study was carried out to assess ultrasound-guided PENG block versus CB for their efficacy, safety and pain management in pediatric hip surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group P | Experimental | Procedure: Pericapsular Nerves Group BlockIn ultrasound-guided pericapsular nerve group block Group , the patient will be positioned in a supine position. The anatomical landmarks, including ilio-pubic eminence, the iliopsoas muscle and tendon, the femoral artery and vein, and the pectineus muscle, will be identified using a 9-12 MHz superficial linear transducer. A lateral to medial in-plane technique will be used to insert a 22-gauge, 50-mm needle. the needle's tip will be positioned at the musculofascial plane, located between the ilio-pubic ramus posteriorly and the psoas tendon anteriorly. Following negative aspiration to avoid intravascular injection, 0.5-1 ml of normal saline will be injected to confirm the correct needle site. A 0.5 ml/kg plain bupivacaine 0.25% will be injected. |
| Group C | Active comparator | Procedure: Caudal Epidural Blockthe caudal epidural block will be established in the lateral decubitus position, the high-frequency linear transducer will be first placed transversely at the midline to obtain a "frog eye" sign view of the sacral cornu, the sacro-coccygeal ligament, the sacrum, and the sacral hiatus. At this position, the USG transducer will be rotated by 90° to obtain a longitudinal view. The needle will be inserted in-plane into the sacral canal and the Local anaesthetics will be injected under real-time visualization by a dose of 0.5 ml/kg plain bupivacaine 0.25%. |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- child aged 1- 7 years old
- American Society of Anesthesiologists (ASA) physical status I-II
- scheduled for elective hip surgery under general anesthesia
Key exclusion criteria (5 listed)
- parents/guardians refusal to participate
- known local anesthetic drug sensitivity,
- bleeding disorders,
- pre-existing infection at the block site, and
- the presence of major cardiac, renal, or hepatic disorders.
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 |
|---|---|---|
| Pericapsular Nerves Group BlockAlso: PENG BlockUSG-guided single-shot PENG in a dose of 0.5 ml/kg of 0.25% bupivacaine per side. | Procedure or surgery | Group P |
| Caudal Epidural BlockAlso: CEBUSG-guided single-shot CEB in a dose of 0.5 mL/kg of 0.25% bupivacaine. | Procedure or surgery | Group C |
Primary outcome
pain score with FLACC
Time frame: 30 minutes postoperative, 1 hour postoperative, 2 hour postoperative, and 6 hours postoperative
(Face, Legs, Activity, Cry, and Consolability scale to assess pain in young children. Each category is scored on a 0-2 scale which results in a total score between 0 (lowest pain) and 10 (worst pain).
5 secondary outcomes
The duration of the block
Time frame: immediately after the intervention, up to 24 hours postoperative
the Time to first postoperative rescue analgesia
Time frame: 24 hours postoperative
Total rescue analgesia consumption
Time frame: 24 hours postoperative
The incidence of postoperative adverse effects
Time frame: 24 hours postoperative
Parents satisfaction score
Time frame: 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 28 Nov 2025.
- 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 study testing Pericapsular Nerves Group Block and Caudal Epidural Block in people with Pain, Postoperative, run by Benha 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 3 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 28 Nov 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?
pain score with FLACC (time frame: 30 minutes postoperative, 1 hour postoperative, 2 hour postoperative, and 6 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 28 Nov 2025.