NCT06811701

Evaluation of Response to Pain From Skull Pin Fixation in Craniotomies

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 120 (actual)
• Sponsor: Diskapi Teaching and Research Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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

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.

Conditions

• Electroencephalography
• Craniotomy Surgery
• Pain Management

Interventions

Type	Name	Description
PROCEDURE	Scalp nerve block	Patient in this group will receive a scalp nerve block using bupivacaine before skull pin fixation to manage to pain.
DRUG	Opioid Anesthetics	Patient in this group will receive IV opioid for pain management before skull pin fixation
PROCEDURE	Local Anesthetic Injection	"Patients in this group will receive a local anesthetic (such as lidocaine) injection at the pin site before skull pin fixation.

Timeline

• Start date: 2025-02-28
• Primary completion: 2025-10-30
• Completion: 2026-01-30
• First posted: 2025-02-06
• Last updated: 2026-02-24

Locations

1 site across 1 country: Turkey (Türkiye)