The Effect of Scalp Block on Surgical Pleth Index(SPI) During a Mayfield Head-holder Insertion

The Effect of Scalp Block on Surgical Pleth Index(SPI) During a Mayfield Head-holder Insertion in Neurosurgery : a Randomized Control Trial

It is a randomized control trial to compare the surgical plethysmographic index (SPI) response during a Mayfield head-holder insertion in neurosurgical patients who receive a scalp block versus those who do not receive the scalp block after induction of anesthesia with propofol with fentanyl and intubation with cis-atracurium.

Study Overview

• Status: Unknown
• Conditions: Pain
• Intervention / Treatment: Procedure: a scalp block

Detailed Description

Study design is a randomized controlled trial Participants include adult neurosurgical patients scheduled to have a Mayfield head-holder insertion for supratentorial craniotomy Intervention is a scalp block prior to a Mayfield head holder insertion. Comparison is 'no scalp block' Outcome is surgical plethysmographic index (SPI) responses during/after a Mayfield head holder insertion Sample size includes 30 cases (15 cases per arm)

The eligible neurosurgical patients will be randomly allocated, by a concealed randomization process, to receive or not to receive a scalp block after induction and intubation with propofol/fentanyl and cisatracurium. Surgical plethysmographic index, direct arterial blood pressure, heart rate (EEG), End tidal Carbondioxide, Bispectral/entropy (40-60) will be recorded every one minute before/after induction and intubation, before/after the scalp block, and before/after the Mayfield head-holder insertion. The Mayfield head-holder insertion will be performed by a neurosurgeon who will be blinded to the allocated groups.

Data analysis is performed to compare the change of SPI during and after the Mayfield head-holder insertion from the baseline in both groups by using repeated measure ANOVA at the significant level of 0.05.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Thailand
  • Chiang Mai, Thailand, 50200
    • Recruiting
    • Dpt Anesthesiology, Faculty of Medicine, Chiang Mai University
    • Contact: Yodying Punjasawadwong, MD, MMed.Sc.; Phone Number: +6653935522; Email: ypunjasa@gmail.com
    • Contact: Yodying Punjasawadwong, MD, MMed.Sc; Phone Number: +6653935522; Email: ypunjasa@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients will receive a Mayfield head-holder insertion for supratentorial craniotomy

Exclusion Criteria:

• History of chronic hypertension, Diabetes mellitus (DM), coronary heart diseases
• Receiving beta blockers
• BMI > 30
• Coagulopathy
• severe liver and renal diseases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: a scalp block; A standard scalp block ,with 0.5% bupivacaine total dose < 3 mg/kg, is performed by an anesthesiologist.	Procedure: a scalp block; Bilateral blocks of six nerves: ie. supraorbital and supraorbital nerves (V1), zygomaticotemporal nerves (V2) , auriculotemporal nerves , greater occipital nerves, and lesser occipital nerves will be performed by a well trained anesthesiologist with 0.5% bupivacaine not exceeding 3 mg/kg
No Intervention: no scalp block; An anesthesiology will pretend to perform the scalp block,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the change of SPI from baseline	30 minutes

Collaborators and Investigators

• Sponsor: Chiang Mai University
• Investigators: Principal Investigator: Sirivimol Punjasawadwong, MD, Dpt Anesthesiology, Faculty of Medicine, Chiang Mai University

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Anticipated): January 1, 2017
• Study Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: September 25, 2016
• First Submitted That Met QC Criteria: September 26, 2016
• First Posted (Estimate): September 27, 2016

Study Record Updates

• Last Update Posted (Estimate): September 27, 2016
• Last Update Submitted That Met QC Criteria: September 26, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: scalp block, surgical peth index
• Other Study ID Numbers: 03457

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED