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CompletedNCT03767868Updated Apr 11, 2019

An Indicator of Successful Peripheral Nerve Block

An observational study in Temperature Change, Body, sponsored by Antalya Training and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-04-11.

Sponsored by Antalya Training and Research Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

After performed the block, sensory and motor block assessments will be carried out by blinded observer every 5 min after needle removal for 30 min in the regions of the radial, median, ulnar, and musculocutaneous nerves of the forearm. Skin temperature measurements will be performed from both the anesthetized side and the contralateral arm before the procedure and every 5 min for 30 min by a blinded observer. Before the block, the color changing nail polish will be applied to all hand nails of the patient. An independent observer will photograph the reaction of the nail polish (i.e. color change) in both hands immediately after application of nail polish and at two minute intervals for 30 min after performing the block. Two blinded observers were reviewed the digital photographs. They were asked to compare the colors of nail polish in both hands and to score the difference based on a three-point scale (0: absolutely no difference, 1: I am not sure, 2: indisputable difference)

02

Conditions studied

  • Temperature Change, Body
03

In context

Body Temperature Changes

93 studies on the registry are indexed under Body Temperature Changes; 20 are open to participants now.

This study's enrollment of 50 is below the median of 99 across 25 observational studies indexed under Body Temperature Changes.

Browse Body Temperature Changes studies →

Lead sponsor

Antalya Training and Research Hospital is the lead sponsor of 102 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability 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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No

Interventions

  • Othercolor change in nail polish

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

06

What researchers measure

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).

    Time frame: 30 minutes

07

Study locations

1 site
  • Antalya Training and Research Hospital
    Antalya, Turkey
08

References and documents

Publications

  • 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. PubMed 31592901 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03767868
Lead sponsor
Antalya Training and Research Hospital
Responsible party
Sponsor
First posted
Dec 7, 2018
Start date
Dec 13, 2018
Primary completion
Mar 1, 2019
Completion
Mar 11, 2019
Last update
Apr 11, 2019

Study contacts

Ali Sait Kavakli, MD
study director · Antalya Training and Research Hospital
Ulku Arslan, MD
principal investigator · Karabuk University
Ferhat Enginar, MD
principal investigator · Antalya Training and Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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