Scalp Block Versus General Anesthesia in Patients Undergoing Evacuation of Subdural Hematoma Via Burr Hole

NCT ID: NCT07143799

Last Updated: 2025-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-11

Study Completion Date

2026-03-20

Brief Summary

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this study amis to compare between Scalp block versus general anesthesia in patients undergoing evacuation of subdural hematoma via burr hole.

Detailed Description

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Conditions

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Subdural Hematoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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'Group A will receive general anesthesia

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.

Group Type ACTIVE_COMPARATOR

Cisatracurium

Intervention Type DRUG

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.

Group B patients will receive scalp block

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

Group Type ACTIVE_COMPARATOR

scalp block

Intervention Type OTHER

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.

Interventions

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Cisatracurium

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.

Intervention Type DRUG

scalp block

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Housny Elsayed

Resident , Anesthesia , Surgical Icu , Pain management Faculty of Medicine Sohag university

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag university hospital

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohamed H elsayed, Resident

Role: CONTACT

01050053614

Abdel Rahman H Abdel Rahman, Professor

Role: CONTACT

01120320258

Facility Contacts

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Magdy M Amin, Professor

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 38980290 (View on PubMed)

Knopman 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.

Reference Type BACKGROUND
PMID: 30646255 (View on PubMed)

Sharma 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.

Reference Type BACKGROUND
PMID: 33066943 (View on PubMed)

Other Identifiers

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Soh-Med--25-8-8MS

Identifier Type: -

Identifier Source: org_study_id

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