Temperature Change, BodyNCT03767868
An Indicator of Successful Peripheral Nerve Block
An observational study of Temperature Change, Body, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Temperature Change, Body
- What is being tested?
- color change in nail polish
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Dec 2018to 11 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- patients who received infraclavicular brachial plexus block for elective elbow, forearm, wrist, or hand surgery
- American Society of Anesthesiologists class I, II or III
Who cannot join
- 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
Show all 9Show fewer
- contraindication for regional anesthesia
- peripheral neurological disease,
- Raynaud disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Antalya Training and Research Hospital
Antalya
About this study
Official title: A Different Indicator of Successful Peripheral Nerve Block
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.
Read the 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)
- Conditions
- Temperature Change, Body
- Being tested
- color change in nail polish
- Medical subject headings
- Body Temperature Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
color change in nail polishOther
The determination of color change in nail polish will be based on differences in skin temperature before and after the block.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start13 Dec 2018
- Primary completion1 Mar 2019
- Study completion11 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Temperature Change, BodyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ali Sait Kavakli, MD, Study director, Antalya Training and Research HospitalUlku Arslan, MD, Principal investigator, Karabuk UniversityFerhat Enginar, MD, Principal investigator, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03767868
- Sponsor's protocol ID
- AntalyaTRH27
- Status last verified
- Dec 2018
- First submitted
- 5 Dec 2018
- Last updated
- 11 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 31592901
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Different Indicator of Successful Peripheral Nerve Block
- ClinicalTrials.gov ID
- NCT03767868
- Acronym / sponsor ID
- AntalyaTRH27
- Conditions
- Temperature Change, Body
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 13 Dec 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 11 Mar 2019 (actual)
- First posted
- 7 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- patients who received infraclavicular brachial plexus block for elective elbow, forearm, wrist, or hand surgery
- American Society of Anesthesiologists class I, II or III
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| color change in nail polishThe determination of color change in nail polish will be based on differences in skin temperature before and after the block. | Other | – |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2019.
- Derived from this study: PubMed 31592901Kavakli 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Sait Kavakli, MD study director
Antalya Training and Research Hospital
Ulku Arslan, MD principal investigator
Karabuk University
Ferhat Enginar, MD principal investigator
Antalya Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Temperature Change, Body, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in the color of nail polish (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03767868, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2019.