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An Indicator of Successful Peripheral Nerve Block

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ClinicalTrials.gov Identifier: NCT03767868
Recruitment Status : Completed
First Posted : December 7, 2018
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Antalya Training and Research Hospital

Study Description
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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.

Condition or disease Intervention/treatment
Temperature Change, Body Other: color change in nail polish

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)

Study Design
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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Different Indicator of Successful Peripheral Nerve Block
Actual Study Start Date : December 13, 2018
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : March 11, 2019
Groups and Cohorts
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Intervention Details:
  • Other: color 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.

Outcome Measures
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Primary Outcome Measures :
  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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03767868


Locations
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Turkey
Antalya Training and Research Hospital
Antalya, Turkey
Sponsors and Collaborators
Antalya Training and Research Hospital
Investigators
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Study Director: Ali Sait Kavakli, MD Antalya Training and Research Hospital
Principal Investigator: Ulku Arslan, MD Karabuk University
Principal Investigator: Ferhat Enginar, MD Antalya Training and Research Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Antalya Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03767868     History of Changes
Other Study ID Numbers: AntalyaTRH27
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Body Temperature Changes
Signs and Symptoms