Cancer BoneNCT07056946
Supra Inguinal Fascia Iliaca Block Versus Ultrasound-guided Caudal Analgesia for Pediatrics Undergoing Anterior and Lateral Thigh Surgeries: A Randomized Controlled Trial
A study testing Fascia Iliaca Nerve Block and Caudal Block Anesthesia in people with Cancer Bone, run by National Cancer Institute, Egypt at 2 sites in Egypt.
Trial summary
patients will then be randomized in the two groups. 1. Group C: in this group children will receive US-guided caudal analgesia (CA) after GA. The caudal block will be performed 2. Group B: in this group children will receive lower limb peripheral nerve blocks in the form of US-guided fascia iliaca Block. Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Cancer Bone
- What is being tested?
- Fascia Iliaca Nerve Block and Caudal Block Anesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Aug 2025to 1 Aug 2026
- 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
- Age 1-7 years
- scheduled for anterior and lateral thigh Surgeries
- American Society of Anesthesiologists (ASA) physical status II or III
Who cannot join
- Refusal of parental consent
- Allergy to any local anesthetics
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
National Cancer institute
Cairo, Cairo Governorate, 002
National Cancer institute
Cairo
About this study
patients will then be randomized in the two groups.
- Group C: in this group children will receive US-guided caudal analgesia (CA) after GA. The caudal block will be performed
- Group B: in this group children will receive lower limb peripheral nerve blocks in the form of US-guided fascia iliaca Block.
Read the detailed description
After assessment of eligibility criteria, a clinical nurse independent of the protocol will obtain the randomization number and patients will then be randomized in the two groups. Treatment allocation will follow the order of a predetermined randomization list and will be generated using random blocks. Randomized will be done through computer program with patient blinded to the type of intervention (single blinded).
- Group C: in this group children will receive US-guided caudal analgesia (CA) after GA. The caudal block will be performed by visualizing the sacral hiatus at the level of the sacral cornu after placing the probe transversely obtaining a short axis view, two hyperechoic lines will appear between the sacral cornu the superficial line is the sacrococcygeal ligament which will be pierced by the needle 22-gauge echogenic non-stimulating 5-cm needle (Ultraplex; B. Braun Medical Bethlehem PA, USA) using the out-of-plane approach. After confirming the absence of any blood or cerebrospinal fluid in the aspiration the caudal mixture (1 mL/kg of 0.125% bupivacaine a maximum volume of 20 mL will be used) will be injected.
- Group B: in this group children will receive lower limb peripheral nerve blocks in the form of US-guided fascia iliaca Block.
American Society of Anesthiologists recommends monitors, intravenous line, and O2 (3 L/min) through the nasal cannula will be used. All blocks will be executed under the guidance of a 5-13 MHz linear ultrasound probe covered in a sterile sheath and attached to a Sonosite (M- Turbo; SonoSite Inc. Bothell WA USA) portable ultrasound machine. Preoperatively the maximum dose of bupivacaine will be calculated (2 mg/kg) so as not to exceed the dose during injection in either group.
- Conditions
- Cancer Bone
- Being tested
- Fascia Iliaca Nerve Block, Caudal Block Anesthesia
- Keywords
- Supra inguinal fascia iliaca Block ,Caudal Analgesia,Pediatrics
- Medical subject headings
- Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fascia Iliaca Nerve BlockOther
With the patient in the proper position, the skin is disinfected and the transducer positioned to identify the femoral artery and the iliopsoas muscle and fascia iliaca. The transducer is moved laterally until the sartorius muscle is identified. After a skin wheal is made, the needle is inserted in-plane
Caudal Block AnesthesiaOther
The caudal block will be performed by visualizing the sacral hiatus at the level of the sacral cornu after placing the probe transversely obtaining a short axis view, two hyperechoic lines will appear between the sacral cornu the superficial line is the sacrococcygeal ligament
| Study group | Role | What they receive |
|---|---|---|
| Group C: in this group children will receive US-guided caudal analgesia (CA) after GA. | Active comparator | The caudal block will be performed by visualizing the sacral hiatus at the level of the sacral cornu after placing the probe transversely obtaining a short axis view Receives: Other: Caudal Block Anesthesia |
| Group B: in this group children will receive lower limb peripheral nerve blocks in the form of US | Experimental | With the patient in the proper position, the skin is disinfected and the transducer positioned to identify the femoral artery and the iliopsoas muscle and fascia iliaca. The transducer is moved laterally until the sartorius muscle is identified. After a skin wheal is made, the needle is inserted in-plane Receives: Other: Fascia Iliaca Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Estimation of time of first rescue postoperative analgesia
Measured: 4 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start1 Aug 2025
- Primary completion1 Aug 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer BoneStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suzan Adlan Abdelrahman, National Cancer Institute, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07056946
- Sponsor's protocol ID
- AP2502-501-098-195
- Status last verified
- Jul 2025
- First submitted
- 29 Jun 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supra Inguinal Fascia Iliaca Block Versus Ultrasound-guided Caudal Analgesia for Pediatrics Undergoing Anterior and Lateral Thigh Surgeries: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07056946
- Acronym / sponsor ID
- AP2502-501-098-195
- Conditions
- Cancer Bone
- Keywords
- Supra inguinal fascia iliaca Block ,Caudal Analgesia,Pediatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 9 Jul 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.
patients will then be randomized in the two groups.
- Group C: in this group children will receive US-guided caudal analgesia (CA) after GA. The caudal block will be performed
- Group B: in this group children will receive lower limb peripheral nerve blocks in the form of US-guided fascia iliaca Block.
Detailed description
After assessment of eligibility criteria, a clinical nurse independent of the protocol will obtain the randomization number and patients will then be randomized in the two groups. Treatment allocation will follow the order of a predetermined randomization list and will be generated using random blocks. Randomized will be done through computer program with patient blinded to the type of intervention (single blinded).
- Group C: in this group children will receive US-guided caudal analgesia (CA) after GA. The caudal block will be performed by visualizing the sacral hiatus at the level of the sacral cornu after placing the probe transversely obtaining a short axis view, two hyperechoic lines will appear between the sacral cornu the superficial line is the sacrococcygeal ligament which will be pierced by the needle 22-gauge echogenic non-stimulating 5-cm needle (Ultraplex; B. Braun Medical Bethlehem PA, USA) using the out-of-plane approach. After confirming the absence of any blood or cerebrospinal fluid in the aspiration the caudal mixture (1 mL/kg of 0.125% bupivacaine a maximum volume of 20 mL will be used) will be injected.
- Group B: in this group children will receive lower limb peripheral nerve blocks in the form of US-guided fascia iliaca Block.
American Society of Anesthiologists recommends monitors, intravenous line, and O2 (3 L/min) through the nasal cannula will be used. All blocks will be executed under the guidance of a 5-13 MHz linear ultrasound probe covered in a sterile sheath and attached to a Sonosite (M- Turbo; SonoSite Inc. Bothell WA USA) portable ultrasound machine. Preoperatively the maximum dose of bupivacaine will be calculated (2 mg/kg) so as not to exceed the dose during injection in either group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group C: in this group children will receive US-guided caudal analgesia (CA) after GA. | Active comparator | Other: Caudal Block AnesthesiaThe caudal block will be performed by visualizing the sacral hiatus at the level of the sacral cornu after placing the probe transversely obtaining a short axis view |
| Group B: in this group children will receive lower limb peripheral nerve blocks in the form of US | Experimental | Other: Fascia Iliaca Nerve BlockWith the patient in the proper position, the skin is disinfected and the transducer positioned to identify the femoral artery and the iliopsoas muscle and fascia iliaca. The transducer is moved laterally until the sartorius muscle is identified. After a skin wheal is made, the needle is inserted in-plane |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 1-7 years
- scheduled for anterior and lateral thigh Surgeries
- American Society of Anesthesiologists (ASA) physical status II or III
Key exclusion criteria (2 listed)
- Refusal of parental consent
- Allergy to any local anesthetics
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 |
|---|---|---|
| Fascia Iliaca Nerve BlockWith the patient in the proper position, the skin is disinfected and the transducer positioned to identify the femoral artery and the iliopsoas muscle and fascia iliaca. The transducer is moved laterally until the sartorius muscle is identified. After a skin wheal is made, the needle is inserted in-plane | Other | Group B: in this group children will receive lower limb peripheral nerve blocks in the form of US |
| Caudal Block AnesthesiaThe caudal block will be performed by visualizing the sacral hiatus at the level of the sacral cornu after placing the probe transversely obtaining a short axis view, two hyperechoic lines will appear between the sacral cornu the superficial line is the sacrococcygeal ligament | Other | Group C: in this group children will receive US-guided caudal analgesia (CA) after GA. |
Primary outcome
• Estimation of time of first rescue postoperative analgesia
Time frame: 4 hours postoperatively
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 15 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fascia Iliaca Nerve Block and Caudal Block Anesthesia in people with Cancer Bone, run by National Cancer Institute, Egypt at 2 sites 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 2 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 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
• Estimation of time of first rescue postoperative analgesia (time frame: 4 hours postoperatively). 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 15 Sep 2026.