Evaluation of Response to Pain From Skull Pin Fixation in Craniotomies

Launched by DISKAPI TEACHING AND RESEARCH HOSPITAL · Feb 5, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how people respond to pain from skull pin fixation during brain surgery, specifically craniotomies. The researchers want to find out if looking at changes in blood pressure, heart rate, and brain wave activity can help them understand how patients feel pain from the skull pins used to hold the head still during the procedure. They are also interested in how different methods to manage this pain might affect the amount of pain medication, specifically narcotic opioids, that patients need after surgery.

To participate in this study, you need to be an adult between 18 and 70 years old, scheduled for elective brain surgery, and in generally good health. You should not have severe cognitive, neurological, or psychiatric conditions, and you must be able to give your consent to join the study. If you do participate, the researchers will monitor your pain response during surgery by analyzing brain activity. This study is not yet recruiting participants, so it’s a good idea to keep an eye out for more information if you or someone you know might be interested.

Gender

ALL

Eligibility criteria

• 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.