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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03776617
Enrollment
120
Registered
2018-12-17
Start date
2019-01-05
Completion date
2019-12-31
Last updated
2019-09-03

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

Conditions

Craniotomy

Keywords

scalp block, craniotomy, dexmedetomidine, ropivacaine

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.

Interventions

PROCEDUREscalp 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.

Sponsors

George Papanicolaou Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
intraoperative opioid consumptionintraoperativeThe 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.
systolic arterial pressure and diastolic arterial pressureintraoperativeThe systolic and diastolic blood pressure and heart rate change from baseline will be calculated. The unit for blood pressure is mmHg.
heart rate fluctuationintraoperativeheart rate change from baseline will be calculated. The unit for heart rate is bpm

Secondary

MeasureTime frameDescription
extubation timeone dayTime from the end of anesthetic to fully awake and extubation

Other

MeasureTime frameDescription
chronic pain after craniotomy3 months after craniotomytelephone 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).

Countries

Greece

Contacts

Primary ContactChrysoula Stachtari, MD, PhD
chryssastachtari@yahoo.gr+306946140458
Backup ContactZoi Stergiouda, MD
zstergiouda@yahoo.gr+306942403938

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026