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Completed

NCT Number: NCT06811701

Evaluation of Response to Pain From Skull Pin Fixation in Craniotomies

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Health Sciences Etlik City Hospital

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Scalp nerve block

Procedure

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

Opioid Anesthetics

Drug

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

Other names: IV fentanyl

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.

Other names: Lidocaine injection at pin site

Primary outcomes

  1. 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

Secondary outcomes

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

    Time frame: Baseline to 5 minutes after skull pin fixation.

    Hemodynamic response will be evaluated by measuring changes in mean arterial pressure before and after skull pin fixation.

Sponsors and collaborators

Lead sponsor

Diskapi Teaching and Research Hospital

Other

Registry information

Official study title

Evaluation of Response to Pain From Skull Pin Fixation in Craniotomies With BIS-DSA (Bıspectral Index-Density Spectral Array) and Hemodynamics

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Feb 6, 2025
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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