Scalp block versus fentanyl infusion in patients undergoing elective craniotomy for supratentorial tumor removal: a randomized controlled trial

A Comparison of Scalp Block and Intravenous Fentanyl in Preventing Hemodynamic Change in Patients Undergoing Elective Craniotomy for Supratentorial Tumor Removal : A Prospective Randomize Controlled Trial.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20210602005

Enrollment

Registered

2021-06-02

Start date

2021-12-01

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 Change during craniotomy : Heart rate, Mean arterial pressure Time to first rescue dose of fentanyl and intraoperative fentanyl consumption scalp block intraoperative hemodynamic change craniotomy fentanyl consumption

Interventions

scalp block will be performed with 0.5% bupivacaine and the dose of bupivacaine is not exceed 3 mg/kg. The following nerves (supraorbital nerve, supratrochlear nerve, zygomaticotemporal nerve, auricul

group S,group F

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Age 18 - 65 years old ASA class I-III Undergo elective craniotomy for supratentorial tumor removal

Exclusion criteria

Exclusion criteria: Glasgow coma score (GCS) less than 13 Patients who undergoing bifrontal craniotomy Systemic hypertension Malignant arrhythmias Cardiac disease Chronic pain Cerebrovascular disease Allergy to local anesthetic drugs Coagulopathy Scalp infection Pregnancy

Design outcomes

Primary

Measure	Time frame
hemodynamic response before pin insertion, during pin insertion, 5/10/15 minutes after pin insertion, during skin incision, during dural incision, during dural closure, and during skin closure HR, MAP	—

Secondary

Measure	Time frame
Time to first rescue dose of fentanyl HR and MAP will be record every 5 minutes HR is elevated more than 10 beats/minute or MAP is increased more than 20% from baseline,total anesthetic cost at the end of surgery research drug cost + other drugs cost + anesthetic service cost,vasopressor requirement intraoperative period amount of patients who required intraoperative vasopressor,time to extubation postoperative period from end of surgery to extubation ,Delirium first 24 hours after surgery Richmond Agitation-Sedation Scale,PONV first 24 hours after surgery incidence of PONV,Cost at the end of surgery Cost of anesthetic drugs	—

Measure

Time frame

Time to first rescue dose of fentanyl HR and MAP will be record every 5 minutes HR is elevated more than 10 beats/minute or MAP is increased more than 20% from baseline,total anesthetic cost at the end of surgery research drug cost + other drugs cost + anesthetic service cost,vasopressor requirement intraoperative period amount of patients who required intraoperative vasopressor,time to extubation postoperative period from end of surgery to extubation ,Delirium first 24 hours after surgery Richmond Agitation-Sedation Scale,PONV first 24 hours after surgery incidence of PONV,Cost at the end of surgery Cost of anesthetic drugs

—

Countries

Thailand

Contacts

Public ContactChanatthee Kitsiripant

Department of Anesthesiology Faculty of Medicine Prince of Songkla University

chanat_k@hotmail.com0955691961

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026