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

NCT07545655 | Not Yet Recruiting

• 1 other identifier: FSMTRH-SD-01
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Craniotomy Surgery

Keywords

Craniotomy; Ultrasound-guided scalp block; Skull pin head holder; Perioperative opioid consumption; Hemodynamic stability; Inflammatory response

Outcome Measures

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.

  0-24 hours postoperatively

Secondary Outcomes (6)

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

  24 hours postoperatively

• Mean arterial pressure during pin head holder placement (mmHg)

  Perioperative/Periprocedural

• Mean systemic immune-inflammation index at 24 hours postoperatively

  24 hours postoperatively

• Mean systemic inflammation response index at 24 hours postoperatively

  24 hours postoperatively

• Number of participants requiring rescue analgesia within 24 hours postoperatively

  0-24 hours postoperatively

Study Arms (2)

patient who scalp block applied

Patients who receive an ultrasound-guided preoperative scalp block before skull pin placement and surgical incision

patient without scalp block applied

Patients who do not receive a scalp block and instead undergo local infiltration anesthesia performed by the surgical team before skull pin placement and surgical incision

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• Allergy to local anesthetics
• Coagulopathy or anticoagulant use
• Local infection at injection site
• Pregnancy or breastfeeding
• Chronic opioid use (\>3 months) or chronic pain syndrome
• Severe psychiatric disorders affecting pain assessment
• Emergency surgery
• Active infection or rheumatic disease
• Hematological disease or malignancy (active or within 5 years)
• Recent use of biological agents, chemotherapy, or corticosteroids (within 30 days)
• NSAID use within 24 hours before surgery
• Advanced organ failure (NYHA III-IV, Child-Pugh C, eGFR \<30 mL/min)
• Refusal to participate
• Communication difficulties preventing pain assessment

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

Study Sites (1)

Fatih Sultan Mehmet Training and Research Hospital

Istanbul, ataşehir, 34752, Turkey (Türkiye)

Location

Related Publications (3)

• Teymourian H, Besarati A, Azizifarsani H, Rostami P, Tafrishinejad A, Tafrishinejad R. Navigating scalp nerve blocks: A comparative study of ultrasound vs. landmark methods. Agri. 2025 Oct;37(4):191-200. doi: 10.14744/agri.2025.49358.

  PMID: 41042039 RESULT

• Li B, Cao Z, Huang J, Chen Y, Li Z, Wu W, Li C, Qiu T, Chen J. Effect of ultrasound-guided scalp nerve block on hemodynamics and postoperative agitation in hypertensive cerebral hemorrhage craniotomy patients: a prospective randomized controlled study. Front Neurol. 2026 Jan 14;16:1721992. doi: 10.3389/fneur.2025.1721992. eCollection 2025.

  PMID: 41613181 RESULT

• Yang X, Ma J, Li K, Chen L, Dong R, Lu Y, Zhang Z, Peng M. A comparison of effects of scalp nerve block and local anesthetic infiltration on inflammatory response, hemodynamic response, and postoperative pain in patients undergoing craniotomy for cerebral aneurysms: a randomized controlled trial. BMC Anesthesiol. 2019 Jun 1;19(1):91. doi: 10.1186/s12871-019-0760-4.

  PMID: 31153358 RESULT

Study Officials

• arzu yıldırım ar, prof

  Fatih Sultan Mehmet Training and Research Hospital

  STUDY DIRECTOR

Central Study Contacts

sevgi duymaz

CONTACT

+905050000882; celebisevgi95@gmail.com

arzu yıldırım ar

CONTACT

+905053822729; dr.arzuyildirim@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: April 22, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): February 10, 2027
• Study Completion (Estimated): March 10, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)