NCT07143799

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 11, 2025

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 27, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2026

Completed
Last Updated

August 27, 2025

Status Verified

August 1, 2025

Enrollment Period

7 months

First QC Date

August 13, 2025

Last Update Submit

August 22, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    24 hours after operation

Study Arms (2)

'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.

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

Other: scalp block

Interventions

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 A will receive general anesthesia

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 B patients will receive scalp block

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university hospital

Sohag, Egypt

RECRUITING

Related Publications (3)

  • 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.

    PMID: 38980290BACKGROUND
  • 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.

    PMID: 30646255BACKGROUND
  • 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.

    PMID: 33066943BACKGROUND

MeSH Terms

Conditions

Hematoma, Subdural

Interventions

cisatracurium

Condition Hierarchy (Ancestors)

Intracranial Hemorrhage, TraumaticIntracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemVascular DiseasesCardiovascular DiseasesHematomaHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsWounds and Injuries

Central Study Contacts

Mohamed H elsayed, Resident

CONTACT

Abdel Rahman H Abdel Rahman, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident , Anesthesia , Surgical Icu , Pain management Faculty of Medicine Sohag university

Study Record Dates

First Submitted

August 13, 2025

First Posted

August 27, 2025

Study Start

August 11, 2025

Primary Completion

March 20, 2026

Study Completion

March 20, 2026

Last Updated

August 27, 2025

Record last verified: 2025-08

Locations