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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02916264
• Other study ID #: 03457
• Status: Recruiting
• Phase: Phase 4
• First received: September 25, 2016
• Last updated: September 26, 2016
• Start date: July 2016
• Est. completion date: March 2017

Study information

• Verified date: September 2016
• Source: Chiang Mai University
• Contact: Sirivimol Punjasawadwong, MD
• Phone: +6653935522
• Email: siriwimol[@]gmail.com
• Is FDA regulated: No
• Health authority: Thailand: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pain

Intervention

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

Locations

Country	Name	City	State
Thailand	Dpt Anesthesiology, Faculty of Medicine, Chiang Mai University	Chiang Mai

Sponsors (1)

Lead Sponsor	Collaborator
Chiang Mai University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the change of SPI from baseline		30 minutes	Yes