NCT03767868

Brief Summary

The aim of the study was to investigate whether a color changing nail polish would be an indicator to assess infraclavicular brachial plexus block success based on skin temperature differences before and after performed the block.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

December 5, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 7, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

December 13, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2019

Completed
Last Updated

April 11, 2019

Status Verified

December 1, 2018

Enrollment Period

3 months

First QC Date

December 5, 2018

Last Update Submit

April 10, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Differences in the color of nail polish

    The photographs showing if there is the reaction of color of nail polish will be assessed after study completion by independent observers. They will be asked to compare the colors of nail polish before and after block performance in both hands and to rate the difference based on a three-point scale (0: absolutely no difference, 1: I am not sure, 2: indisputable difference).

    30 minutes

Interventions

The determination of color change in nail polish will be based on differences in skin temperature before and after the block.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults between 18 and 65 years of age with infraclavicular brachial lexus block for elective elbow, forearm, wrist, or hand surgery , were selected in the study.

You may qualify if:

  • patients who received infraclavicular brachial plexus block for elective elbow, forearm, wrist, or hand surgery
  • American Society of Anesthesiologists class I, II or III

You may not qualify if:

  • patients \<18 years old
  • \>65 years old
  • body mass index (BMI) \<20 or \>35 kg/m2
  • inability to provide written informed consent
  • refusal of regional anesthesia
  • pregnancy
  • contraindication for regional anesthesia
  • peripheral neurological disease,
  • Raynaud disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antalya Training and Research Hospital

Antalya, Turkey (Türkiye)

Location

Related Publications (1)

  • Kavakli AS, Enginar F, Arslan U, Ozdemir F. Thermochromic nail polish as a novel indicator to predict infraclavicular brachial plexus block success: A prospective cohort study. Eur J Anaesthesiol. 2019 Dec;36(12):911-917. doi: 10.1097/EJA.0000000000001091.

MeSH Terms

Conditions

Body Temperature Changes

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ali Sait Kavakli, MD

    Antalya Training and Research Hospital

    STUDY DIRECTOR
  • Ulku Arslan, MD

    Karabuk University

    PRINCIPAL INVESTIGATOR
  • Ferhat Enginar, MD

    Antalya Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2018

First Posted

December 7, 2018

Study Start

December 13, 2018

Primary Completion

March 1, 2019

Study Completion

March 11, 2019

Last Updated

April 11, 2019

Record last verified: 2018-12

Locations