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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

Tracking Information
First Submitted Date December 5, 2018
First Posted Date December 7, 2018
Last Update Posted Date April 11, 2019
Actual Study Start Date December 13, 2018
Actual Primary Completion Date March 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 6, 2018)
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).
Original Primary Outcome Measures
 (submitted: December 5, 2018)
color change in nail polish [ Time Frame: 30 minutes ]
The determination of color change in nail polish will be based on differences in skin temperature before and after the block.
Change History Complete list of historical versions of study NCT03767868 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title An Indicator of Successful Peripheral Nerve Block
Official Title A Different Indicator of Successful Peripheral Nerve Block
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.
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Temperature Change, Body
Intervention 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.
Study Groups/Cohorts Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 5, 2018)
50
Original Estimated Enrollment Same as current
Actual Study Completion Date March 11, 2019
Actual Primary Completion Date March 1, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT03767868
Other Study ID Numbers AntalyaTRH27
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Antalya Training and Research Hospital
Study Sponsor Antalya Training and Research Hospital
Collaborators Not Provided
Investigators
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
PRS Account Antalya Training and Research Hospital
Verification Date December 2018