NCT02916264

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Chiang Mai University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Pain

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-01-01
• Completion: 2017-03-01
• First posted: 2016-09-27
• Last updated: 2016-09-27

Locations

1 site across 1 country: Thailand