ElectroencephalographyNCT06811701
Evaluation of Response to Pain From Skull Pin Fixation in Craniotomies
An observational study of Electroencephalography and Craniotomy Surgery, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to investigate the relationship between the response to skull pin fixation pain and the analysis of blood pressure, heart rate, and brain wave activity in adults undergoing brain surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Electroencephalography, Craniotomy Surgery, Pain Management
- What is being tested?
- Scalp nerve block, Opioid Anesthetics and Local Anesthetic Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Feb 2025to 30 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: "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.
Who may be able to join
- 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).
Who cannot join
- 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:
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- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Etlik City Hospital
Ankara
About this study
Official title: Evaluation of Response to Pain From Skull Pin Fixation in Craniotomies With BIS-DSA (Bıspectral Index-Density Spectral Array) and Hemodynamics
The goal of this observational study is to investigate the relationship between the response to skull pin fixation pain and the analysis of blood pressure, heart rate, and brain wave activity in adults undergoing brain surgery. The main questions it aims to answer are:
Does the analysis of blood pressure, heart rate, and brain wave activity indicate the patient's response to skull pin fixation pain during brain surgery? How do the methods used to reduce skull pin fixation pain in brain surgeries affect narcotic opioid consumption? The researchers will monitor the patients' response to skull pin fixation pain during surgery through the analysis of brain wave activity.
Read the detailed description
Adult patients undergoing elective craniotomy under general anesthesia will be evaluated. Methods used to manage pin-related pain will be categorized into three approaches: intravenous opioids, local Methods used to manage pin-related pain will be categorised into three approaches: intravenous opioids, local anaesthetic injection at the pin site, and scalp block. injection at the pin site, and scalp block. The patient's The patient's haemodynamic responses and reactions to painful stimuli recorded by the BIS-DSA monitor during skull clamp placement will be documented. responses and reactions to painful stimuli recorded by the BIS-DSA monitor during skull clamp placement will be documented. These records are automatically archived in the BIS-DSA device.Waveform data will be converted into numerical values using a predefined hue-based algorithm.
- Conditions
- Electroencephalography, Craniotomy Surgery, Pain Management
- Being tested
- Scalp nerve block, Opioid Anesthetics, Local Anesthetic Injection
- Keywords
- depth of anaesthesia, Bispectral index-Density Spectral array, skull clamp pain, noxious
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scalp nerve blockProcedure or surgery
Also called Scalp nerve block with bupivacaine
Patient in this group will receive a scalp nerve block using bupivacaine before skull pin fixation to manage to pain.
Opioid AnestheticsDrug
Also called IV fentanyl
Patient in this group will receive IV opioid for pain management before skull pin fixation
Local Anesthetic InjectionProcedure or surgery
Also called Lidocaine injection at pin site
"Patients in this group will receive a local anesthetic (such as lidocaine) injection at the pin site before skull pin fixation.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Scalp group | "This group consists of patients who receive a scalp nerve block for pain management during skull pin fixation." Receives: Procedure: Scalp nerve block | |
| Group 2: Opioid Group | "This group consists of patients who receive intravenous opioids for pain management during skull pin fixation." Receives: Drug: Opioid Anesthetics | |
| Group 3: Local Anesthetic Group | "This group consists of patients who receive a local anesthetic injection at the pin site before skull pin fixation." Receives: Procedure: Local Anesthetic Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in BIS-DSA spectral analysis before and after skull pin fixation
The primary outcome measure will be the changes in brain wave activity, specifically in the BIS-DSA spectral analysis, before and after skull pin fixation. This will be assessed by comparing the pre- and post-fixation BIS values and spectral features such as alpha dropout, beta arousal, and delta changes
Measured: From baseline (before skull pin fixation) to 5 minutes after skull pin fixation.
Secondary outcomes (1)
Changes in Mean Arterial Pressure (MAP) before and after skull pin fixation
Hemodynamic response will be evaluated by measuring changes in mean arterial pressure before and after skull pin fixation.
Measured: Baseline to 5 minutes after skull pin fixation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start28 Feb 2025
- Primary completion30 Oct 2025
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElectroencephalographyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ceyda Ozhan Caparlar, Diskapi Teaching and Research Hospital
- Investigators
- Ceyda Ozhan Caparlar, MD, Principal investigator, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06811701
- Sponsor's protocol ID
- AESH-BADEK-2024-1016
- Status last verified
- Jul 2026
- First submitted
- 28 Jan 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Response to Pain From Skull Pin Fixation in Craniotomies With BIS-DSA (Bıspectral Index-Density Spectral Array) and Hemodynamics
- ClinicalTrials.gov ID
- NCT06811701
- Acronym / sponsor ID
- AESH-BADEK-2024-1016
- Conditions
- Electroencephalography, Craniotomy Surgery, Pain Management
- Keywords
- depth of anaesthesia, Bispectral index-Density Spectral array, skull clamp pain, noxious
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to investigate the relationship between the response to skull pin fixation pain and the analysis of blood pressure, heart rate, and brain wave activity in adults undergoing brain surgery. The main questions it aims to answer are:
Does the analysis of blood pressure, heart rate, and brain wave activity indicate the patient's response to skull pin fixation pain during brain surgery? How do the methods used to reduce skull pin fixation pain in brain surgeries affect narcotic opioid consumption? The researchers will monitor the patients' response to skull pin fixation pain during surgery through the analysis of brain wave activity.
Detailed description
Adult patients undergoing elective craniotomy under general anesthesia will be evaluated. Methods used to manage pin-related pain will be categorized into three approaches: intravenous opioids, local Methods used to manage pin-related pain will be categorised into three approaches: intravenous opioids, local anaesthetic injection at the pin site, and scalp block. injection at the pin site, and scalp block. The patient's The patient's haemodynamic responses and reactions to painful stimuli recorded by the BIS-DSA monitor during skull clamp placement will be documented. responses and reactions to painful stimuli recorded by the BIS-DSA monitor during skull clamp placement will be documented. These records are automatically archived in the BIS-DSA device.Waveform data will be converted into numerical values using a predefined hue-based algorithm.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Scalp group | – | Procedure: Scalp nerve block"This group consists of patients who receive a scalp nerve block for pain management during skull pin fixation." |
| Group 2: Opioid Group | – | Drug: Opioid Anesthetics"This group consists of patients who receive intravenous opioids for pain management during skull pin fixation." |
| Group 3: Local Anesthetic Group | – | Procedure: Local Anesthetic Injection"This group consists of patients who receive a local anesthetic injection at the pin site before skull pin fixation." |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- "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.
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scalp nerve blockAlso: Scalp nerve block with bupivacainePatient in this group will receive a scalp nerve block using bupivacaine before skull pin fixation to manage to pain. | Procedure or surgery | Group 1: Scalp group |
| Opioid AnestheticsAlso: IV fentanylPatient in this group will receive IV opioid for pain management before skull pin fixation | Drug | Group 2: Opioid Group |
| Local Anesthetic InjectionAlso: Lidocaine injection at pin site"Patients in this group will receive a local anesthetic (such as lidocaine) injection at the pin site before skull pin fixation. | Procedure or surgery | Group 3: Local Anesthetic Group |
Primary outcome
Changes in BIS-DSA spectral analysis before and after skull pin fixation
Time frame: From baseline (before skull pin fixation) to 5 minutes after skull pin fixation.
The primary outcome measure will be the changes in brain wave activity, specifically in the BIS-DSA spectral analysis, before and after skull pin fixation. This will be assessed by comparing the pre- and post-fixation BIS values and spectral features such as alpha dropout, beta arousal, and delta changes
1 secondary outcome
Changes in Mean Arterial Pressure (MAP) before and after skull pin fixation
Time frame: Baseline to 5 minutes after skull pin fixation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ceyda Ozhan Caparlar, MD principal investigator
Ankara Etlik City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Electroencephalography and Craniotomy Surgery, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in BIS-DSA spectral analysis before and after skull pin fixation (time frame: From baseline (before skull pin fixation) to 5 minutes after skull pin fixation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.