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Comparison of the Anatomical landmark technique and Ultrasound-Guided Scalp Block on Hemodynamic Response Following Skull Pin Fixation in Patients Undergoing Elective Craniotomy: A Randomized Controlled Trial

Comparison of the Anatomical landmark technique and Ultrasound-Guided Scalp Block on Hemodynamic Response Following Skull Pin Fixation in Patients Undergoing Elective Craniotomy: A Randomized Controlled Trial

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250711002
Enrollment
70
Registered
2025-07-11
Start date
2025-07-15
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodynamic changes following skull pinning in patients undergoing craniotomy for brain tumor removal Brain tumor Craniotomy with tumor removal Hemodynamic changes following skull pinning

Interventions

Performing anatomical landmark technique scalp block (Technique as described by Pinosky et al(2) and the article by Dr. Supriya Dsouza and Dr. Darreul Sewell(20)) -Supraorbital nerve block Identified
Experimental Procedure/Surgery,Experimental Procedure/Surgery
Group C (Conventional landmark technique),Group U (Ultrasound-guided technique)

Sponsors

Khon Kaen university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1 Age 18 to 65 years 2 ASA 1-3 3 Undergoing elective craniotomy with 4 skull pinning

Exclusion criteria

Exclusion criteria: 1 Patient refuses to participate 2 Allergy to the drugs used in the study 3 Patient undergoing intraoperative nerve monitoring 4 Poor control of hypertensive condition (baseline BP more than 160/110 mmHg) SBP less than 90 mmHg and HR less than 50 bpm before surgery 5 Coagulopathy 6 Scalp infection 7 Chronic pain

Design outcomes

Primary

MeasureTime frame
Mean arterial pressure at 5 minutes after skull pin application 5 minutes after skull pin application Mean arterial pressure (MAP) measured using an arterial line (a-line)

Secondary

MeasureTime frame
Heart rate and mean arterial pressure response at 30 seconds, 1 minute, 2 minutes, 3 minutes, 4 minutes and 5 minutes after skull pin fixation at 30 seconds, 1 minute, 2 minutes, 3 minutes, 4 minutes and 5 minutes after skull pin fixation Mean arterial pressure (MAP) measured using an arterial line (a-line),Duration of scalp block the time required to perform the scalp block time count,Postoperative pain 12 and 24 hours postoperatively the verbal numerical rating scale (vNRS) or the behavioral pain scale (if vNRS cannot be obtained),Cumulative intraoperative propofol consumption intraoperative period data recorded by the infusion pump,Cumulative intraoperative fentanyl consumption intraoperative period data recorded by the infusion pump,Cumulative fentanyl consumption in the first 24 hours postoperatively duration of the first 24 hours postoperatively recorded by the nurse,Scalp block-related postoperative adverse events at 24 hours postoperatively, including: Hypotension (SBP less than 90 mmHg) Bradycardia (HR less than 50 bpm) Facial nerve palsy 24 hours postoperatively observed by the nurse

Countries

Thailand

Contacts

Public ContactNichapat Iammethawee

Faculty of Medicine, Khon Kaen University

Pornchanit.iam@kkumail.com0999426351

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026