Scalp Block in Elective Craniotomy for Tumor Dissection Trial

Regional Scalp Block With Ropivacaine 0.5% in Patients Undergoing Elective Craniotomy: a Prospective Randomized Controlled Trial

This study was designed to evaluate the effect of scalp block combined with general anesthesia on the intraoperative consumption of fentanyl and time of extubation of patients undergoing elective craniotomy. Scalp block will be applied to three groups with differences of the administered solution to the scalp and one group will be placebo group.

Study Overview

• Status: Unknown
• Conditions: Craniotomy
• Intervention / Treatment: Procedure: scalp block

Detailed Description

Regional scalp block (RSB) is an established technique that involves infiltration of local anesthetic (LA) at well-defined anatomical sites targeting the major sensory innervation of the scalp. Regional techniques minimize anesthetic requirements and their effects may be beneficial. There is a lack of consensus and evidence concerning alternative analgesia strategies for cranial neurosurgery.

Patients undergoing elective craniotomy for tumor dissection will be randomly divided into four groups to receive scalp block as an adjuvant to general anesthesia. After a standard induction sequence using propofol, fentanyl and a single dose of rocuronium, patients will be intubated. Bilateral scalp block will be given immediately after induction, except patients in control group who will not have a scalp block. Drugs for scalp block will be 20ml ropivacaine 0.5%, 20ml xylocaine 1% and dexmedetomidine 1mcg/kg.Anaesthesia will be maintained with propofol and remifentanyl infusion. Intraoperatively, propofol infusion at 75 to 100 μg/kg/h up to dura closure and reduced to 50-75 μg/kg/h up to skin closure. Five minutes before head pinning scalp block was performed by blocking the supraorbital, supratrochlear, auriculotemporal, occipital, and postauricular branches of the greater auricular nerves.Routine monitoring of electrocardiogram, heart rate (HR), and mean arterial blood pressure (MAP) will record at two-minute intervals from the beginning of anesthesia until 10 minutes after incision, followed by 5-minute intervals throughout the remaining course of the surgery. Monitoring of the depth of anesthesia will also performed using the Bispectral Index. Sample size was calculated based on Type I error of α = 5% and power = 80% and minimum difference d = 30%, which is clinically significant in the pilot study. All quantitative variables will be reported as mean and standard deviation, and qualitative variables will be listed as number (percentage). Mann-Whitney test and Chi-square test will be used for comparison of endpoints. Linear mixed model will be used to evaluate the differences of hemodynamics variables. Statistical Package for Social Sciences (SPSS, version 19.0; SPSS Inc., Chicago, USA) will be used for all calculations. p values less than .05 will be considered significant.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chrysoula Stachtari, MD, PhD; Phone Number: +306946140458; Email: chryssastachtari@yahoo.gr
• Study Contact Backup: Name: Zoi Stergiouda, MD; Phone Number: +306942403938; Email: zstergiouda@yahoo.gr

Study Locations

• Greece
  • Thessaloníki, Greece, 57010
    • Recruiting
    • George Papanikoalou Hospital
    • Contact: Chrysoula Stachtari, MD, PhD; Email: chryssastachtari@yahoo.gr
    • Contact: Zoi Stergiouda, MD; Email: zstergiouda@yahoo.gr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients with American Society of Anesthesiologists Physical status classification 1-3
• patients who are scheduled for elective craniotomy for brain tumor
• patients who have provided consent for participation in the study

Exclusion Criteria:

• Patients who have allergy to local anesthetics and dexmedetomidine
• Glasgow coma scale <15
• tumor>4cm
• any contraindication for receiving dexmedetomidine
• severe mental impairment
• pregnant women
• uncontrolled hypertension, arrhythmia, coagulation disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group Ropivacaine; general anesthesia + scalp block with 20 ml xylocaine 1% and 20ml ropivacaine 0.5%	Procedure: scalp block; Scalp block will be performed five minutes before head pinning for elective craniotomy by blocking supraorbital, auriculotemporal, occipital and postauricular branches of the greater auricular nerves.
Experimental: Group Ropivacaine-Dexmedetomidine; general anesthesia + scalp block with 20 ml xylocaine 1%, 20ml ropivacaine 0.5% and 1mcg/kg dexmedetomidine	Procedure: scalp block; Scalp block will be performed five minutes before head pinning for elective craniotomy by blocking supraorbital, auriculotemporal, occipital and postauricular branches of the greater auricular nerves.
No Intervention: Group control; general anesthesia
Sham Comparator: Group sham; general anesthesia + Scalp block with 40ml Normal Saline	Procedure: scalp block; Scalp block will be performed five minutes before head pinning for elective craniotomy by blocking supraorbital, auriculotemporal, occipital and postauricular branches of the greater auricular nerves.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraoperative opioid consumption	The overall intravenous fentanyl and remifentanil consumption (microgram/ kilogram) during the surgery. The decision to administer fentanyl is guided by the changes of blood pressure and/ or heart rate greater than 20% from baseline level.	intraoperative
systolic arterial pressure and diastolic arterial pressure	The systolic and diastolic blood pressure and heart rate change from baseline will be calculated. The unit for blood pressure is mmHg.	intraoperative
heart rate fluctuation	heart rate change from baseline will be calculated. The unit for heart rate is bpm	intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
extubation time	Time from the end of anesthetic to fully awake and extubation	one day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
chronic pain after craniotomy	telephone after 3 months and ask for pain description using the Numeric Pain Rating Scale (NPRS). A respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").	3 months after craniotomy

Collaborators and Investigators

• Sponsor: George Papanicolaou Hospital
• Investigators: Study Director: Anastasia Trikoupi, MD, PhD, General Hospital of Thessaloniki

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2019
• Primary Completion (Anticipated): November 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: May 16, 2018
• First Submitted That Met QC Criteria: December 12, 2018
• First Posted (Actual): December 17, 2018

Study Record Updates

• Last Update Posted (Actual): September 3, 2019
• Last Update Submitted That Met QC Criteria: August 29, 2019
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: dexmedetomidine; ropivacaine; craniotomy; scalp block
• Other Study ID Numbers: ScalCran

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No