An Indicator of Successful Peripheral Nerve Block

Temperature Change, Body Clinical Trial

Official title:

A Different Indicator of Successful Peripheral Nerve Block

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03767868
• Other study ID #: AntalyaTRH27
• Status: Completed
• Start date: December 13, 2018
• Est. completion date: March 11, 2019

Study information

• Verified date: December 2018
• Source: Antalya Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 11, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Temperature Changes
• 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.

Locations

Country	Name	City	State
Turkey	Antalya Training and Research Hospital	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Antalya Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in the color of nail polish	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).	30 minutes