Evaluation of Response to Pain From Skull Pin Fixation in Craniotomies

NCT06811701 | Completed

• 1 other identifier: AESH-BADEK-2016-1016
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Electroencephalography; Craniotomy Surgery; Pain Management

Keywords

depth of anaesthesia; Bispectral index-Density Spectral array; skull clamp pain; noxious

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes in Mean Arterial Pressure (MAP) before and after skull pin fixation

  Baseline to 5 minutes after skull pin fixation.

Study Arms (3)

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

Group 2: Opioid Group

"This group consists of patients who receive intravenous opioids for pain management during skull pin fixation."

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."

Procedure: Local Anesthetic Injection

Interventions

Scalp nerve block PROCEDURE

Patient in this group will receive a scalp nerve block using bupivacaine before skull pin fixation to manage to pain.

Also known as: Scalp nerve block with bupivacaine

Group 1: Scalp group

Opioid Anesthetics DRUG

Patient in this group will receive IV opioid for pain management before skull pin fixation

Also known as: IV fentanyl

Group 2: Opioid Group

Local Anesthetic Injection PROCEDURE

"Patients in this group will receive a local anesthetic (such as lidocaine) injection at the pin site before skull pin fixation.

Also known as: Lidocaine injection at pin site

Group 3: Local Anesthetic Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Diskapi Teaching and Research Hospital: lead

Study Sites (1)

University of Health Sciences Etlik City Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia

Interventions

Bupivacaine; Fentanyl; Anesthetics, Local

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Ceyda Ozhan Caparlar, MD

  Ankara Etlik City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 6, 2025
• Study Start: February 28, 2025
• Primary Completion: October 30, 2025
• Study Completion: January 30, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)