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Recruiting NCT07143799

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

No phase Interventional Subdural Hematoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cisatracurium, scalp block.
Who it may be relevant to
Registry conditions: Subdural Hematoma. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Interventions

  • Drug 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.
  • Other 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.

Primary outcome measures

  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Egypt · 1 center
  • Sohag university hospital — Sohag

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. PMID 38980290
  • 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 30646255
  • 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 33066943

Identifiers

NCT: NCT07143799 · Soh-Med--25-8-8MS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗