Evaluation of Response to Pain From Skull Pin Fixation in Craniotomies

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.

Study Overview

• Status: Completed
• Conditions: Pain Management; Electroencephalography; Craniotomy Surgery
• Intervention / Treatment: Procedure: Scalp nerve block; Drug: Opioid Anesthetics; Procedure: Local Anesthetic Injection

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 Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye)
    • University of Health Sciences Etlik City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1: Scalp group; "This group consists of patients who receive a scalp nerve block for pain management during skull pin fixation."	Procedure: Scalp nerve block; Patient in this group will receive a scalp nerve block using bupivacaine before skull pin fixation to manage to pain.; Other Names: Scalp nerve block with bupivacaine
Group 2: Opioid Group; "This group consists of patients who receive intravenous opioids for pain management during skull pin fixation."	Drug: Opioid Anesthetics; Patient in this group will receive IV opioid for pain management before skull pin fixation; Other Names: IV fentanyl
Group 3: Local Anesthetic Group; "This group consists of patients who receive a local anesthetic injection at the pin site before skull pin fixation."	Procedure: Local Anesthetic Injection; "Patients in this group will receive a local anesthetic (such as lidocaine) injection at the pin site before skull pin fixation.; Other Names: Lidocaine injection at pin site

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From baseline (before skull pin fixation) to 5 minutes after skull pin fixation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to 5 minutes after skull pin fixation.

Collaborators and Investigators

• Sponsor: Diskapi Teaching and Research Hospital
• Investigators: Principal Investigator: Ceyda Ozhan Caparlar, MD, Ankara Etlik City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2025
• Primary Completion (Actual): October 30, 2025
• Study Completion (Actual): January 30, 2026

Study Registration Dates

• First Submitted: January 28, 2025
• First Submitted That Met QC Criteria: February 5, 2025
• First Posted (Actual): February 6, 2025

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 22, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: noxious; depth of anaesthesia; Bispectral index-Density Spectral array; skull clamp pain
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Agnosia; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Anilides; Amides; Aniline Compounds; Amines; Piperidines; Central Nervous System Agents; Bupivacaine; Fentanyl; Anesthetics, Local
• Other Study ID Numbers: AESH-BADEK-2016-1016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No