An Indicator of Successful Peripheral Nerve Block

Completed

• Conditions: Temperature Change, Body

• Registration Number: NCT03767868
• Lead Sponsor: Antalya Training and Research Hospital

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 Timeline

• Status Verified: 2018-12
• Study First Submitted: 2018-12-05
• Study First Submitted QC: 2018-12-05
• Study First Posted: 2018-12-07
• Study Start: 2018-12-13
• Primary Completion: 2019-03-01
• Study Completion: 2019-03-11
• Last Update Submitted: 2019-04-10
• Last Update Posted: 2019-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differences in the color of nail polish	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).

Trial Locations

Locations (1)

Antalya Training and Research Hospital; 🇹🇷 Antalya, Turkey