Effects of Ultrasound-Guided Scalp Block on Opioid Use, Hemodynamics, and Postoperative Inflammation in Craniotomy

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFatih Sultan Mehmet Training and Research Hospital

About this trial

This study shows that in craniotomy patients using a skull pin head holder, an ultrasound-guided scalp block reduces perioperative opioid consumption, improves hemodynamic stability, and decreases the inflammatory response.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 years and older

Scheduled for elective intracranial surgery with skull pin head holder fixation

Classified as American Society of Anesthesiologists (ASA) physical status I-III

Provided written informed consent in the preoperative period

Disqualifiers

Allergy to local anesthetics

Coagulopathy or anticoagulant use

Local infection at injection site

Pregnancy or breastfeeding

Trial population

Patients aged 18 years and older who are scheduled for elective intracranial surgery under general anesthesia with planned skull pin head holder (Mayfield-type) fixation, classified as American Society of Anesthesiologists (ASA) physical status I-III, and who have provided informed consent will be included.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

60 Participants
are grouped into 2 trial groups
Group A: patient who scalp block applied
Group B: patient without scalp block applied

Trial outcomes

Primary outcomes

1

Total opioid consumption within 24 hours postoperatively (morphine milligram equivalents, mg)

All opioid analgesics administered within 24 hours postoperatively will be converted to morphine milligram equivalents (mg) for each participant. The outcome will be reported as a single total value per participant.

Time frame
0-24 hours postoperatively

Secondary outcomes

1

Mean resting pain score at 24 hours postoperatively measured using the Numeric Rating Scale (0-10)

Pain intensity at rest will be assessed using the Numeric Rating Scale (0 = no pain, 10 = worst imaginable pain). The outcome will be reported as the mean score at 24 hours. Higher scores indicate greater pain severity.

Time frame
24 hours postoperatively
2

Mean arterial pressure during pin head holder placement (mmHg)

Mean arterial pressure (MAP) will be recorded in mmHg during pin head holder placement. The outcome will be reported as the MAP value at this time point

Time frame
Perioperative/Periprocedural
3

Mean systemic immune-inflammation index at 24 hours postoperatively

The systemic immune-inflammation index (SII) will be calculated for each participant using laboratory values obtained at 24 hours postoperatively as platelet count × neutrophil count / lymphocyte count. The outcome will be reported as the mean SII value.

Time frame
24 hours postoperatively
4

Mean systemic inflammation response index at 24 hours postoperatively

The systemic inflammation response index (SIRI) will be calculated for each participant using laboratory values obtained at 24 hours postoperatively as monocyte count × neutrophil count / lymphocyte count. The outcome will be reported as the mean SIRI value.

Time frame
24 hours postoperatively

Other outcomes

Sponsors and contacts

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