Evaluation of Response to Pain From Skull Pin Fixation in Craniotomies

N/ANot Yet RecruitingNCT06811701

Diskapi Teaching and Research Hospital120 enrolled

Overview

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.

Patients with an ASA (American Society of Anesthesiologists) score of I-II who are undergoing elective craniotomy under general anesthesia with the use of a skull clamp will be included in the study. The methods used to manage patients' pin-related pain will be recorded on the follow-up form: 1-intravenous opioids, 2- local anesthetic (LA) injection at the pin site, and 3- scalp block. The patients' hemodynamic responses and their reactions to painful stimuli, as recorded by the BIS-DSA monitor, will be documented during the placement of the skull clamp. These records are automatically archived in the BIS-DSA device. Waveform analyses from the BIS-DSA will later be converted into numerical values using the "Hue formula."

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

Electroencephalography Craniotomy Surgery Pain Management

Scalp nerve blockPROCEDURE

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

Opioid AnestheticsDRUG

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

Local Anesthetic InjectionPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients aged 18-70 years undergoing elective craniotomy. * Patients classified as ASA I-II 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 III 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.

Outcomes

Primary Outcomes

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

Time frame: From baseline (before skull pin fixation) to 5 minutes after skull pin fixation.

Secondary Outcomes

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.

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