I62.0
Conditions
Interventions
Group 1: Burr hole craniotomy for chronic subdural hematoma under local anesthesia (LA). Local anesthesia of the scalp over the parietal tuber and pericranium is administered using a 1:1 mixture of 0.
Sponsors
Charité - Universitätsmedizin Berlin, Klinik für Neurochirurgie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Adult patients (age = 18 years) - Symptomatic and asymptomatic cSDH confirmed by imaging (MRI/CT) that require surgical treatment - Informed consent of the patient. Only patients capable of giving informed consent will be included.
Exclusion criteria
Exclusion criteria: - No consent for participation - Bilateral cSDH, both of which require surgical treatment - Preoperative delirium - Patients with conditions for which surgery under local or general anaesthesia is contraindicated o Known allergy to lidocaine or bupivacaine o Known allergy or contraindication to epinephrine o Patients with a history of psychiatric disorders that could make awake surgery difficult and jeopardise the patient's safety during surgery (panic disorder/episodic paroxysmal anxiety, claustrophobia) - Previous participation in this study - Time interval from admission to surgery > 24 hours - CSDH in the presence of a CSF shunt
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Postoperative complication rate until discharge (evaluated as binary outcome per patient) - Postoperative delirium rate until discharge, measured every 8 hours by physicians using CAM (evaluated as binary outcome per patient) - Recruitment rate; two rates will be examined: 1. all patients who consent (consent rate) and 2. all patients who are then operated on according to their randomization (surgery rate after randomization) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Complication rate 1 month after surgery (evaluated as binary outcome per patient) - Glasgow Coma Scale (GCS) at discharge from the neurosurgery department and 1 month after surgery - Markwalder cSDH scale on discharge from the neurosurgery department and 1 month after the operation - Modified Rankin Scale (mRS) at discharge from the neurosurgery department and 1 month after surgery - Barthel Index at discharge from the neurosurgery department and 1 month after surgery - Mortality (1 month after surgery) - Length of stay on the neurosurgical ward - Discharge location from the neurosurgery department - Health economic analysis - In case of non-consent/withdrawal: survey and analysis of the reasons at which point in time and why the patients do not wish to participate | — |
Countries
Germany
Contacts
Public ContactPeter Vajkoczy
Charité - Universitätsmedizin Berlin, Klinik für Neurochirurgie
Outcome results
None listed