Pain PostoperativePhase 3NCT07411274
Ultrasound-Guided vs. Conventional Scalp Block for Postoperative Analgesia in Pediatric Supratentorial Tumor Surgeries
A Phase 3 study testing Ultrasound-guided scalp block and conventional scalp block in people with Pain Postoperative, run by Cairo University.
Trial summary
Although scalp nerve blocks have been shown to provide effective postoperative analgesia in pediatric neurosurgical procedures, limited data exist on their use under ultrasound guidance. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Pain Postoperative
- What is being tested?
- Ultrasound-guided scalp block and conventional scalp block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to Oct 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I, II.
- Undergoing elective supratentorial tumor surgery under general anesthesia on one side of the head.
Who cannot join
- Urgent/emergency craniotomy.
- Coagulopathy or platelet dysfunction.
- Allergy to local anesthetics.
- Pre-existing bradycardia (HR <60 bpm in infants, <50 bpm in older children) or unstable arrhythmias.
- Severe hepatic/renal impairment.
About this study
Official title: Comparison of Ultrasound-Guided vs. Conventional Scalp Block for Postoperative Analgesia in Pediatric Supratentorial Tumor Surgeries: A Randomized Controlled Trial.
Although scalp nerve blocks have been shown to provide effective postoperative analgesia in pediatric neurosurgical procedures, limited data exist on their use under ultrasound guidance. The smaller anatomical structures and higher vascularity of the pediatric scalp increase the risk of inadvertent vessel puncture or systemic toxicity with landmark-based techniques. Ultrasound guidance enables direct visualization of the targeted nerves and adjacent vessels, potentially improving block accuracy and safety. To date, no randomized controlled trial has compared ultrasound-guided versus conventional scalp block specifically in pediatric supratentorial tumor surgeries. This study aims to fill this gap.
- Conditions
- Pain Postoperative
- Being tested
- Ultrasound-guided scalp block, conventional scalp 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.
Ultrasound-guided scalp blockProcedure or surgery
Patients will receive ultrasound-guided scalp block using bupivacaine 0.25% at 0.1-0.2 mL/kg per nerve site, not exceeding a total dose of 2.5 mg/kg.
conventional scalp blockProcedure or surgery
Patients will receive conventional scalp block using landmark-based technique with bupivacaine 0.25% at 0.1-0.2 mL/kg per nerve site, not exceeding a total dose of 2.5 mg/kg.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-guided scalp block using bupivacaine | Active comparator | patients will recieve ultrasound-guided scalp block using bupivacaine Receives: Procedure: Ultrasound-guided scalp block |
| conventional scalp block using bupivacaine | Active comparator | patients will recieve conventional scalp block with bupivacaine using a landmark-based technique Receives: Procedure: conventional scalp block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean arterial blood pressure intraoperatively from baseline till skin incision
The mean arterial blood pressure recorded during 5 minutes immediately before skin incision till the peak mean arterial blood pressure recorded within the first minute after incision
Measured: from 5 minutes immediately before skin incision till the peak mean arterial blood pressure recorded within the first minute after incision
Secondary outcomes (4)
Duration of analgesia
The time to the first postoperative analgesic request
Measured: 24 hours postoperatively
objective pain scale
objective pain scale is based on 5 criteria:
(1) systolic arterial blood pressure, (2) crying, (3) movement, (4) agitation, and (5) verbal evaluation (complaint of pain). Each criterion is allocated a score of 0 to 2 (2 being the worst), giving a minimum OPS score of 0 and the maximum possible score of 10; the worst OPS score is 10 if the child is old enough to complain of pain and 8 if the child is too young to complain of pain
Measured: 2, 4, 6, 8, 12, 16, and 24 hours postoperatively
Total doses of ketorolac
Measured: 24 hours postoperatively
6. Total dose of paracetamol
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AbdElKhalik Mahmoud Shaban, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07411274
- Sponsor's protocol ID
- MD-403-2025
- Status last verified
- Jan 2026
- First submitted
- 26 Jan 2026
- Last updated
- 13 Feb 2026
- 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 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound-Guided vs. Conventional Scalp Block for Postoperative Analgesia in Pediatric Supratentorial Tumor Surgeries: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07411274
- Acronym / sponsor ID
- MD-403-2025
- Conditions
- Pain Postoperative
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 13 Feb 2026 (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.
Although scalp nerve blocks have been shown to provide effective postoperative analgesia in pediatric neurosurgical procedures, limited data exist on their use under ultrasound guidance. The smaller anatomical structures and higher vascularity of the pediatric scalp increase the risk of inadvertent vessel puncture or systemic toxicity with landmark-based techniques. Ultrasound guidance enables direct visualization of the targeted nerves and adjacent vessels, potentially improving block accuracy and safety. To date, no randomized controlled trial has compared ultrasound-guided versus conventional scalp block specifically in pediatric supratentorial tumor surgeries. This study aims to fill this gap.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-guided scalp block using bupivacaine | Active comparator | Procedure: Ultrasound-guided scalp blockpatients will recieve ultrasound-guided scalp block using bupivacaine |
| conventional scalp block using bupivacaine | Active comparator | Procedure: conventional scalp blockpatients will recieve conventional scalp block with bupivacaine using a landmark-based technique |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical status I, II.
- Undergoing elective supratentorial tumor surgery under general anesthesia on one side of the head.
Key exclusion criteria (5 listed)
- Urgent/emergency craniotomy.
- Coagulopathy or platelet dysfunction.
- Allergy to local anesthetics.
- Pre-existing bradycardia (HR <60 bpm in infants, <50 bpm in older children) or unstable arrhythmias.
- Severe hepatic/renal impairment.
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 |
|---|---|---|
| Ultrasound-guided scalp blockPatients will receive ultrasound-guided scalp block using bupivacaine 0.25% at 0.1-0.2 mL/kg per nerve site, not exceeding a total dose of 2.5 mg/kg. | Procedure or surgery | Ultrasound-guided scalp block using bupivacaine |
| conventional scalp blockPatients will receive conventional scalp block using landmark-based technique with bupivacaine 0.25% at 0.1-0.2 mL/kg per nerve site, not exceeding a total dose of 2.5 mg/kg. | Procedure or surgery | conventional scalp block using bupivacaine |
Primary outcome
Mean arterial blood pressure intraoperatively from baseline till skin incision
Time frame: from 5 minutes immediately before skin incision till the peak mean arterial blood pressure recorded within the first minute after incision
The mean arterial blood pressure recorded during 5 minutes immediately before skin incision till the peak mean arterial blood pressure recorded within the first minute after incision
4 secondary outcomes
Duration of analgesia
Time frame: 24 hours postoperatively
objective pain scale
Time frame: 2, 4, 6, 8, 12, 16, and 24 hours postoperatively
Total doses of ketorolac
Time frame: 24 hours postoperatively
6. Total dose of paracetamol
Time frame: 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ultrasound-guided scalp block and conventional scalp block in people with Pain Postoperative, run by Cairo University.
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: opening soon, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Mean arterial blood pressure intraoperatively from baseline till skin incision (time frame: from 5 minutes immediately before skin incision till the peak mean arterial blood pressure recorded within the first minute after incision). 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 13 Feb 2026.