Scalp Block in Elective Craniotomy for Tumor Dissection Trial

NCT ID: NCT03776617

Last Updated: 2019-09-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-05
• Study Completion Date: 2019-12-31

Brief Summary

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.

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.

Conditions

Craniotomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group Ropivacaine

general anesthesia + scalp block with 20 ml xylocaine 1% and 20ml ropivacaine 0.5%

Group Type: EXPERIMENTAL

scalp block

Intervention Type: PROCEDURE

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.

Group Ropivacaine-Dexmedetomidine

general anesthesia + scalp block with 20 ml xylocaine 1%, 20ml ropivacaine 0.5% and 1mcg/kg dexmedetomidine

Group Type: EXPERIMENTAL

scalp block

Intervention Type: PROCEDURE

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.

Group control

general anesthesia

Group Type: NO_INTERVENTION

No interventions assigned to this group

Group sham

general anesthesia + Scalp block with 40ml Normal Saline

Group Type: SHAM_COMPARATOR

scalp block

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

George Papanicolaou Hospital

OTHER

Sponsor Role: lead

Responsible Party

Stachtari Chrysoula MD, PhD

Stachtari Chrysoula, Consultant Anesthesiologist, G. Papanikolaou Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anastasia Trikoupi, MD, PhD

Role: STUDY_DIRECTOR

General Hospital of Thessaloniki

Locations

George Papanikoalou Hospital

Thessaloniki, , Greece

Site Status: RECRUITING

Countries

Greece

Central Contacts

Chrysoula Stachtari, MD, PhD

Role: CONTACT

chryssastachtari@yahoo.gr

+306946140458

Zoi Stergiouda, MD

Role: CONTACT

zstergiouda@yahoo.gr

+306942403938

Facility Contacts

Chrysoula Stachtari, MD, PhD

Role: primary

chryssastachtari@yahoo.gr

Zoi Stergiouda, MD

Role: backup

zstergiouda@yahoo.gr

Other Identifiers

ScalCran

Identifier Type: -

Identifier Source: org_study_id