Subdural HematomaNCT07143799
Scalp Block Versus General Anesthesia in Patients Undergoing Evacuation of Subdural Hematoma Via Burr Hole
A study testing Cisatracurium and scalp block in people with Subdural Hematoma, run by Sohag University at 1 site in Egypt.
Trial summary
this study amis to compare between Scalp block versus general anesthesia in patients undergoing evacuation of subdural hematoma via burr hole. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Subdural Hematoma
- What is being tested?
- Cisatracurium and scalp block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Aug 2025to 20 Mar 2026
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 75 years old.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status II-III.
- Patients with subdural hematoma undergoing burr-hole evacuation
Who cannot join
- Patients with a history of known sensitivity to study drugs.
- Glasgow Coma Scale (GCS) <8
- Impaired coagulation profile.
- Any degree of heart block.
- Infection at site of injection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Abdel Rahman H Abdel Rahman, Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university hospital
Sohag
Magdy M Amin, Professor
About this study
this study amis to compare between Scalp block versus general anesthesia in patients undergoing evacuation of subdural hematoma via burr hole.
- Conditions
- Subdural Hematoma
- Being tested
- Cisatracurium, scalp block
- Medical subject headings
- Hematoma, Subdural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisatracuriumDrug
Induction of general anesthesia will be done by IV propofol 2-2.5 mg / kg and IV fentanyl lug/kg. After IV Cis-atracurium 0.15mg/kg, endotracheal intubation will be done.
scalp blockOther
The scalp block will target six pairs of sensory nerves that innervate the scalp: the supraorbital nerve, supratrochlear nerve, auriculotemporal nerve, zygomaticotemporal nerve, greater occipital nerve, and lesser occipital nerve. Local anesthetic (2% lidocaine and bupivacaine) will be infiltrated at specific anatomical landmarks corresponding to the course of each nerve.
| Study group | Role | What they receive |
|---|---|---|
| 'Group A will receive general anesthesia | Active comparator | Induction of general anesthesia will be done by IV propofol 2-2.5 mg / kg and IV fentanyl lug/kg. After IV Cis-atracurium 0.15mg/kg, endotracheal intubation will be done. Receives: Drug: Cisatracurium |
| Group B patients will receive scalp block | Active comparator | The scalp block will target six pairs of sensory nerves that innervate the scalp: the supraorbital nerve, supratrochlear nerve, auriculotemporal nerve, zygomaticotemporal nerve, greater occipital nerve, and lesser occipital nerve.Local anesthetic (2% lidocaine and bupivacaine) will be infiltrated at specific anatomical landmarks corresponding to the course of each nerve Receives: Other: scalp block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The aim of this prospective randomized study is to compare Scalp block versus general anesthesia in patients undergoing evacuation of subdural hematoma via burr hole.
Post operative scale by The Glasgow Coma Scale (GCS) and post operative hemodynamics.
Measured: 24 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start11 Aug 2025
- Primary completion20 Mar 2026 (estimated)
- Study completion20 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Subdural HematomaStudies of the same condition, open and under way.
- More trials run by Sohag 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Housny Elsayed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07143799
- Sponsor's protocol ID
- Soh-Med--25-8-8MS
- Status last verified
- Aug 2025
- First submitted
- 13 Aug 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Scruton TJ. Updates on the diagnosis and management of subdural hematoma. JAAPA. 2024 Aug 1;37(8):9-15. doi: 10.1097/01.JAA.0000000000000055. Epub 2024 Jul 25.
PubMed 38980290Knopman J, Link TW, Navi BB, Murthy SB, Merkler AE, Kamel H. Rates of Repeated Operation for Isolated Subdural Hematoma Among Older Adults. JAMA Netw Open. 2018 Oct 5;1(6):e183737. doi: 10.1001/jamanetworkopen.2018.3737.
PubMed 30646255Sharma R, Rocha E, Pasi M, Lee H, Patel A, Singhal AB. Subdural Hematoma: Predictors of Outcome and a Score to Guide Surgical Decision-Making. J Stroke Cerebrovasc Dis. 2020 Nov;29(11):105180. doi: 10.1016/j.jstrokecerebrovasdis.2020.105180. Epub 2020 Aug 7.
PubMed 33066943
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scalp Block Versus General Anesthesia in Patients Undergoing Evacuation of Subdural Hematoma Via Burr Hole
- ClinicalTrials.gov ID
- NCT07143799
- Acronym / sponsor ID
- Soh-Med--25-8-8MS
- Conditions
- Subdural Hematoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 11 Aug 2025 (actual)
- Primary completion
- 20 Mar 2026 (estimated)
- Study completion
- 20 Mar 2026 (estimated)
- First posted
- 27 Aug 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.
this study amis to compare between Scalp block versus general anesthesia in patients undergoing evacuation of subdural hematoma via burr hole.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 'Group A will receive general anesthesia | Active comparator | Drug: CisatracuriumInduction of general anesthesia will be done by IV propofol 2-2.5 mg / kg and IV fentanyl lug/kg. After IV Cis-atracurium 0.15mg/kg, endotracheal intubation will be done. |
| Group B patients will receive scalp block | Active comparator | Other: scalp blockThe scalp block will target six pairs of sensory nerves that innervate the scalp: the supraorbital nerve, supratrochlear nerve, auriculotemporal nerve, zygomaticotemporal nerve, greater occipital nerve, and lesser occipital nerve.Local anesthetic (2% lidocaine and bupivacaine) will be infiltrated at specific anatomical landmarks corresponding to the course of each nerve |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age from 18 to 75 years old.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status II-III.
- Patients with subdural hematoma undergoing burr-hole evacuation
Key exclusion criteria (5 listed)
- Patients with a history of known sensitivity to study drugs.
- Glasgow Coma Scale (GCS) <8
- Impaired coagulation profile.
- Any degree of heart block.
- Infection at site of injection
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 |
|---|---|---|
| CisatracuriumInduction of general anesthesia will be done by IV propofol 2-2.5 mg / kg and IV fentanyl lug/kg. After IV Cis-atracurium 0.15mg/kg, endotracheal intubation will be done. | Drug | 'Group A will receive general anesthesia |
| scalp blockThe scalp block will target six pairs of sensory nerves that innervate the scalp: the supraorbital nerve, supratrochlear nerve, auriculotemporal nerve, zygomaticotemporal nerve, greater occipital nerve, and lesser occipital nerve. Local anesthetic (2% lidocaine and bupivacaine) will be infiltrated at specific anatomical landmarks corresponding to the course of each nerve. | Other | Group B patients will receive scalp block |
Primary outcome
The aim of this prospective randomized study is to compare Scalp block versus general anesthesia in patients undergoing evacuation of subdural hematoma via burr hole.
Time frame: 24 hours after operation
Post operative scale by The Glasgow Coma Scale (GCS) and post operative hemodynamics.
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 27 Aug 2025.
- Background: PubMed 38980290Scruton TJ. Updates on the diagnosis and management of subdural hematoma. JAAPA. 2024 Aug 1;37(8):9-15. doi: 10.1097/01.JAA.0000000000000055. Epub 2024 Jul 25.
- Background: PubMed 30646255Knopman J, Link TW, Navi BB, Murthy SB, Merkler AE, Kamel H. Rates of Repeated Operation for Isolated Subdural Hematoma Among Older Adults. JAMA Netw Open. 2018 Oct 5;1(6):e183737. doi: 10.1001/jamanetworkopen.2018.3737.
- Background: PubMed 33066943Sharma R, Rocha E, Pasi M, Lee H, Patel A, Singhal AB. Subdural Hematoma: Predictors of Outcome and a Score to Guide Surgical Decision-Making. J Stroke Cerebrovasc Dis. 2020 Nov;29(11):105180. doi: 10.1016/j.jstrokecerebrovasdis.2020.105180. Epub 2020 Aug 7.
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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.
Abdel Rahman H Abdel Rahman, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cisatracurium and scalp block in people with Subdural Hematoma, run by Sohag 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 4 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: looking for participants now, as of the sponsor's last update on 27 Aug 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?
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?
Contact Mohamed H elsayed, Resident (01050053614, sakr422022@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The aim of this prospective randomized study is to compare Scalp block versus general anesthesia in patients undergoing evacuation of subdural hematoma via burr hole. (time frame: 24 hours after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07143799, which also lists 3 linked publications.
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 27 Aug 2025.