Brain wave monitor may reveal hidden pain during surgery
NCT ID NCT06811701
First seen Jun 26, 2026 · Last updated Jul 24, 2026 · Updated 2 times
Summary
This completed study with 120 adults undergoing brain surgery tested whether brain wave patterns and vital signs like blood pressure can show pain from skull pin fixation. Researchers compared three pain management methods: a scalp nerve block, IV opioids, and a local anesthetic injection at the pin site. The goal was to see which method best controls pain and reduces opioid use, using brain wave monitoring as a guide.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could help doctors better monitor and manage pain during brain surgery using brain wave analysis.
- What could go wrong
- This is an observational study, not a treatment trial. It only measures responses, so it won't directly improve pain management yet.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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120 people
The number who actually took part.
- Started
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Feb 2025
- Finished
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Jan 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
"This study will include adult patients undergoing elective craniotomy under general anesthesia. Participants will be assigned to different pain management techniques (scalp nerve block, intravenous opioids, or local anesthetic injection) to evaluate their effects on BIS-DSA spectral analysis and hemodynamic responses.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Adult patients aged 18-70 years undergoing elective craniotomy. * Patients classified as ASA 1-3 according to the American Society of Anesthesiologists (ASA) classification. * Patients scheduled for surgery under general anesthesia. * Patients who provide written informed consent to participate in the study. * Patients with normal cognitive function (i.e., no diagnosed dementia or severe cognitive impairment). * Patients with a preoperative BIS value within the normal range (i.e., no extreme baseline deviations). Exclusion Criteria: * Patients classified as ASA 4 or higher. * Patients with neurological disorders (e.g., Parkinson's disease, epilepsy, stroke history). * Patients with psychiatric disorders (e.g., severe depression, schizophrenia) that may affect pain perception and response. * Patients with known allergies to local anesthetics or opioids. * Pregnant or breastfeeding women. * Patients with contraindications to anesthesia, including but not limited to: * Severe cardiovascular disease (e.g., uncontrolled hypertension, recent myocardial infarction). * Severe respiratory disease (e.g., COPD, uncontrolled asthma). * Patients with any neurological or pharmacological condition that may interfere with BIS-DSA or EEG measurements. * Patients with preoperative chronic opioid use (≥3 months) due to potential tolerance affecting response to intraoperative analgesia. * Patients with a history of substance abuse that may alter the BIS response or anesthetic metabolism. * Patients with significant hearing or communication impairments, preventing them from understanding or responding to preoperative assessments. * Patients with significant scalp pathology (e.g., infections, scars, large vascular malformations) at the BIS electrode placement site, which may interfere with signal acquisition.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Health Sciences Etlik City Hospital
Ankara, Turkey (Türkiye)
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