NCT02916264

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4 pain

Timeline
Completed

Started Jul 2016

Shorter than P25 for phase_4 pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

September 27, 2016

Status Verified

September 1, 2016

Enrollment Period

6 months

First QC Date

September 25, 2016

Last Update Submit

September 26, 2016

Conditions

Pain

Keywords

scalp block, surgical peth index

Outcome Measures

Primary Outcomes (1)

  • the change of SPI from baseline

    30 minutes

Study Arms (2)

a scalp block

ACTIVE COMPARATOR

A standard scalp block ,with 0.5% bupivacaine total dose \< 3 mg/kg, is performed by an anesthesiologist.

Procedure: a scalp block

no scalp block

NO INTERVENTION

An anesthesiology will pretend to perform the scalp block,

Interventions

a scalp blockPROCEDURE

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

a scalp block

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dpt Anesthesiology, Faculty of Medicine, Chiang Mai University

Chiang Mai, Chiang Mai, 50200, Thailand

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sirivimol Punjasawadwong, MD

    Dpt Anesthesiology, Faculty of Medicine, Chiang Mai University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sirivimol Punjasawadwong, MD

CONTACT

+6653935522siriwimol@gmail.com

Sirvimol Punjasawadwong, MD

CONTACT

+6653935522siriwimol@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 25, 2016

First Posted

September 27, 2016

Study Start

July 1, 2016

Primary Completion

January 1, 2017

Study Completion

March 1, 2017

Last Updated

September 27, 2016

Record last verified: 2016-09

Locations

TH(1)