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Completed

NCT Number: NCT03767868

An Indicator of Successful Peripheral Nerve Block

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.

Completed

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Antalya Training and Research Hospital

Antalya, Turkey (Türkiye)

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

color change in nail polish

Other

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

Primary outcomes

  1. Differences in the color of nail polish

    Time frame: 30 minutes

    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).

Sponsors and collaborators

Lead sponsor

Antalya Training and Research Hospital

Other Gov

Registry information

Official study title

A Different Indicator of Successful Peripheral Nerve Block

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 7, 2018
Registry last updated
Apr 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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