Evaluation of Response to Pain From Skull Pin Fixation in Craniotomies

NCT ID: NCT06811701

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2025-05-30

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.

Detailed Description

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."

Conditions

Electroencephalography; Craniotomy Surgery; Pain Management

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1: Scalp group

"This group consists of patients who receive a scalp nerve block for pain management during skull pin fixation."

Scalp nerve block

Intervention Type: PROCEDURE

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

Group 2: Opioid Group

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

Opioid Anesthetics

Intervention Type: DRUG

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

Group 3: Local Anesthetic Group

"This group consists of patients who receive a local anesthetic injection at the pin site before skull pin fixation."

Local Anesthetic Injection

Intervention Type: PROCEDURE

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

Interventions

Scalp nerve block

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

Intervention Type: PROCEDURE

Opioid Anesthetics

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

Intervention Type: DRUG

Local Anesthetic Injection

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

Intervention Type: PROCEDURE

Other Intervention Names

Scalp nerve block with bupivacaine; IV fentanyl; Lidocaine injection at pin site

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Diskapi Teaching and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ceyda Ozhan Caparlar

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ceyda Ozhan Caparlar, MD

Role: PRINCIPAL_INVESTIGATOR

Ankara Etlik City Hospital

Central Contacts

Ceyda Ozhan Caparlar, MD

Role: CONTACT

mdceydacaparlar@yahoo.com

+905052919489

Aylin Kılıcarslan, MD

Role: CONTACT

klncrsln_aylnn@hotmail.com

+905382663580

Other Identifiers

AESH-BADEK-2016-1016

Identifier Type: -

Identifier Source: org_study_id