Posterior Fossa TumorPhase 3NCT07878156

Dexmedetomidine Use for Greater Occipital Nerve Block in Pediatric Posterior Fossa Tumor Surgery.

A Phase 3 study testing Bupivacaine 0.25%, Dexmedetomidine 1mcg/kg and Blind greater occipital nerve block in people with Posterior Fossa Tumor, run by Children's Cancer Hospital Egypt 57357 at 1 site in Egypt.

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Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

The goal of this clinical trial is to evaluate the effects of ultrasound-guided versus blind greater occipital nerve block (GONB), with or without Dexmedetomidine as an adjuvant, in pediatric patients undergoing posterior fossa tumor excision under general anesthesia. Read more about this study

Who is it for?: Ages Up to 18 years
Conditions the study is for: Posterior Fossa Tumor
What is being tested?: Bupivacaine 0.25%, Dexmedetomidine 1mcg/kg and Blind greater occipital nerve block
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 260 participants
Where: 1 siteEgypt
Study dates: 17 Dec 2025to 31 Mar 2027
Phase: Phase 3

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 Up to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Pediatric patient undergoing elective posterior fossa tumor excision.
ASA physical status II-III.
Informed consent obtained from parents or legal guardians.

Who cannot join

Allergy to study drugs (Bupivacaine - Dexmedetomidine)
Local infection at the site of injection.
Coagulopathy or use of anticoagulants.
Pre-existing neurologic deficits that interfere with postoperative pain assessment.
Developmental delay preventing appropriate pain evaluation.
Hemodynamic instability prior induction.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Nancy Ashraf Abdellatif contact

+201141083507

nancy.ashraf@57357.com

Dina Elgalaly contact

dina.elgalaly@57357.org

Egypt1 site, 1 recruiting

Children's Cancer Hospital 57357
Cairo
Dina Elgalaly, delgalaly@gmail.com
Recruiting

Other trials in Egypt

About this study

Official title: Dexmedetomidine as an Adjuvant for Ultrasound Guided Greater Occipital Nerve Block in Children Undergoing Posterior Fossa Tumor: A Prospective Randomized Controlled Trial

The main questions it aims to answer are:

Does ultrasound-guided GONB improve hemodynamic stability compared with the blind technique?
Does adding dexmedetomidine to GONB affect intraoperative and postoperative opioid consumption, postoperative pain control, and the time to first rescue analgesia?

Researchers will compare four groups to evaluate the effects of the nerve block technique and the addition of dexmedetomidine:

Group A: Blind GONB using 0.25% bupivacaine. Group B: Blind GONB using 0.25% bupivacaine with dexmedetomidine (1 μg/kg). Group C: Ultrasound-guided GONB using 0.25% bupivacaine. Group D: Ultrasound-guided GONB using 0.25% bupivacaine with dexmedetomidine (1 μg/kg).

Participants will be pediatric patients scheduled for elective posterior fossa tumor excision at Children's Cancer Hospital Egypt (CCHE 57357). They will be randomly assigned to one of the four groups and will receive standardized general anesthesia and bilateral GONB according to their assigned group. Intraoperative heart rate and blood pressure, intraoperative and postoperative opioid consumption, and time to first postoperative rescue analgesia will be assessed.

Conditions: Posterior Fossa Tumor
Being tested: Bupivacaine 0.25%, Dexmedetomidine 1mcg/kg, Blind greater occipital nerve block, Ultrasound-guided greater occipital nerve block
Keywords: greater occipital nerve block, Dexmedetomidine, postoperative pain, pediatric neurosurgery
Medical subject headings: Infratentorial Neoplasms, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bupivacaine 0.25%Drug
Bupivacaine 0.25% will be used for bilateral greater occipital nerve block in pediatric patients undergoing posterior fossa tumor excision.
Dexmedetomidine 1mcg/kgDrug
Dexmedetomidine at a dose of 1 mcg/kg will be added to Bupivacaine 0.25%for bilateral greater occipital nerve block in pediatric patients undergoing posterior fossa tumor excision.
Blind greater occipital nerve blockProcedure or surgery
Bilateral greater occipital nerve block performed using the blind technique in pediatric patients undergoing posterior fossa tumor excision. .
Ultrasound-guided greater occipital nerve blockProcedure or surgery
Bilateral greater occipital nerve block performed under ultrasound guidance in pediatric patients undergoing posterior fossa tumor excision. .

Study groups in NCT07878156
Study group	Role	What they receive
Group A: Blind GONB with Bupivacaine.	Experimental	Participants will receive a blind bilateral greater occipital nerve block using 0.25% Bupivacaine. Receives: Drug: Bupivacaine 0.25%; Procedure: Blind greater occipital nerve block
Group B: Blind GONB with Dexmedetomidine.	Experimental	Participants will receive a blind bilateral greater occipital nerve block using 0.25% Bupivacaine with Dexmedetomidine 1mcg/kg. Receives: Drug: Bupivacaine 0.25%; Drug: Dexmedetomidine 1mcg/kg; Procedure: Blind greater occipital nerve block
Group C: Ultrasound-guided GONB.	Experimental	Participants will receive an ultrasound-guided bilateral greater occipital nerve block using 0.25% Bupivacaine. Receives: Drug: Bupivacaine 0.25%; Procedure: Ultrasound-guided greater occipital nerve block
Group D: Ultrasound-guided GONB with Dexmedetomidine.	Experimental	Participants will receive an ultrasound-guided bilateral greater occipital nerve block using 0.25% Bupivacaine with Dexmedetomidine 1mcg/kg. Receives: Drug: Bupivacaine 0.25%; Drug: Dexmedetomidine 1mcg/kg; Procedure: Ultrasound-guided greater occipital nerve block

What is being measured

The primary outcome is the main question the study is designed to answer.

mean arterial pressure (MAP)
mean arterial pressure will be assessed to evaluate the effects of ultrasound-guided versus blind greater occipital nerve block and using Dexmedetomidine as an adjuvant.
Measured: Intraoperatively post nerve block injection

Secondary outcomes (3)

Heart rate (HR)
heart rate will be measured to assess hemodynamic responses following greater occipital nerve block.
Measured: intraoperatively post nerve block injection
Intraoperative and postoperative opioid consumption
total opioid consumption intraoperatively and postoperatively will be assessed and compared among the four study groups
Measured: during the surgery and postoperatively
time to first postoperative rescue analgesia
the time from completion of surgery to administration of the first rescue analgesic will be recorded to evaluate the duration of postoperative analgesia
Measured: from the end of surgery to the administration of the first rescue analgesic

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Dec 202531 Mar 2027

First posted16 Oct 2026
Study start17 Dec 2025
Primary completion30 Dec 2026 (estimated)
Study completion31 Mar 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Posterior Fossa TumorStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: A randomized, four arm parallel-group study evaluating the effects of greater occipital nerve block technique (blind vs. ultrasound-guided) and dexmedetomidine as an adjuvant (with vs. without) in pediatric patients undergoing posterior fossa tumor excision.
Masking: None (open label)
Enrolment: 260 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07878156
Sponsor's protocol ID: N-0065-006-025
Status last verified: Oct 2026
First submitted: 10 Oct 2026
Last updated: 16 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Nancy Ashraf Abdellatif

+201141083507

nancy.ashraf@57357.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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