Clinical trial NCT03767868: An Indicator of Successful Peripheral Nerve Block
Official title: A Different Indicator of Successful Peripheral Nerve Block
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Temperature Change, Body
Lead sponsor: Antalya Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2018-12-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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)

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

Primary outcomes:
measure: Differences in the color of nail polish
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Antalya Training and Research Hospital
Study officials:
affiliation: Antalya Training and Research Hospital
name: Ali Sait Kavakli, MD
role: STUDY_DIRECTOR
affiliation: Karabuk University
name: Ulku Arslan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Antalya Training and Research Hospital
name: Ferhat Enginar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.