Scalp Block in Elective Craniotomy for Tumor Dissection Trial

NCT03776617 | Unknown DMC

• 1 other identifier: ScalCran
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Craniotomy

Keywords

scalp block; craniotomy; dexmedetomidine; ropivacaine

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• extubation time

  one day

Other Outcomes (1)

• chronic pain after craniotomy

  3 months after craniotomy

Study Arms (4)

Group Ropivacaine

EXPERIMENTAL

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

Procedure: scalp block

Group Ropivacaine-Dexmedetomidine

EXPERIMENTAL

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

Procedure: scalp block

Group control

NO INTERVENTION

general anesthesia

Group sham

SHAM COMPARATOR

general anesthesia + Scalp block with 40ml Normal Saline

Procedure: scalp block

Interventions

scalp block 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; Group Ropivacaine-Dexmedetomidine; Group sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• George Papanicolaou Hospital: lead

Study Sites (1)

George Papanikoalou Hospital

Thessaloniki, 57010, Greece

RECRUITING

Study Officials

• Anastasia Trikoupi, MD, PhD

  General Hospital of Thessaloniki

  STUDY DIRECTOR

Central Study Contacts

Chrysoula Stachtari, MD, PhD

CONTACT

+306946140458; chryssastachtari@yahoo.gr

Zoi Stergiouda, MD

CONTACT

+306942403938; zstergiouda@yahoo.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Stachtari Chrysoula, Consultant Anesthesiologist, G. Papanikolaou Hospital

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: December 17, 2018
• Study Start: January 5, 2019
• Primary Completion: November 1, 2019
• Study Completion: December 1, 2019
• Last Updated: September 3, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)