Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001610426
Ethics application status
Approved
Date submitted
22/10/2016
Date registered
21/11/2016
Date last updated
20/12/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of latency time of local anesthetics among four Commonly Used Agents in Digital Nerve Block
Scientific title
Onset time of anesthesia in local anesthetics with or without epinephrine. A Randomized double blind clinical trial in healthy volunteers
Secondary ID [1] 290204 0
NONE
Universal Trial Number (UTN)
U1111-1187-9168
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Drug indicated for toe surgery (ingrown toenail/onychocryptosis...) 300369 0
Condition category
Condition code
Anaesthesiology 300231 300231 0 0
Anaesthetics
Skin 300232 300232 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Determine the latency time of anesthesia of four commonly anesthetics used in Podiatry. We will have 4 arms:

Arm 1: Bupivacaine 0,5%
Arm 2: Bupivacaine 0,5% + ephinefrine 1:200.000
Arm 3: Lidocaine 2%
Arm 4: Lidocaine 2% + epinephrine 1:100.000

The dose administered: 2cc of anesthetic solution
- The duration of administration: 20 seconds
- The mode of administration: dorsal subcutaneous digital block.

Each group are considered comparator/control of the others groups

The infiltration with local anesthetisc will be do by a podiatrist-researcher specialized in toe surgery with 4 years experience.

We will select healthy volunteers, who sign a consent form and a healthy test to determine his health and determine inclusion criteria (ASA I) . The participants will be randomly allocated to one of the four groups using a randomisation table created by computer software.

A assistant will prepare the anesthetic solution and he will give the preparation to the researcher, who will infíltrate the patient. The patients and the researcher are blind to the type of local anaesthesia. We will infíltrate 2cc of local anesthetics solution in the second toe single dorsal approach. The maximum time of infiltration is 20 seconds.


One assitant will start the chronometer after administration and stopping when the patient has no pain after the pin prick test, Every 10 second we will do a pin prick test in infiltrated toe to determine the pain sensitivity, until the participand has no pain, we record data of latency time in a logsheet. We will repeat until the participant has no pain manifestation.

To Assessed the local anesthetic safety profile we controlled the SO2 (oxigen saturation) with a Blood Oxygen Monitor in the infiltred toe and we compared the oxigen flow among groups. We controled the oxigen saturation after antesthetic adminitration (1 min, 3 min, 5 min, 10 min,20 minutes, 30 minutes, 40 minutes, 50 minutes, 60 minutes). We register a safety curve with the data of the differents groups.

The study procedure will be conducted at clinical area of Seville University (Spain)
Intervention code [1] 295963 0
Treatment: Drugs
Comparator / control treatment
each group is controlled by another group. We are comparing the different latency time of anesthesia between bupivacaine, bupivacaine plus epinephrine, lidocaine and lidocaine plus epinephrine.
Control group
Active

Outcomes
Primary outcome [1] 299721 0
toe pain using pinprick test under the toe nail matrix.

To assessed this outcome we asked the participant if he has pain or not when we do the pinprick test. (YES/NO reponse)
.
Timepoint [1] 299721 0
Baseline and every 10 seconds after intervention administration until participant has no pain
Primary outcome [2] 299722 0
Latency time of anesthesia. We used a chronometer initialing intervention after administration and ending when the patient has no pain.

simple yes/no response following pinprick test under toe nail matrix.
Timepoint [2] 299722 0
Baseline and every 10 seconds after intervention administration until participant has no pain.
Secondary outcome [1] 327946 0
Assessing Local Anesthetics safety profile in toes.

Safety profile, assessed by oxygen saturation of the treated toe by blood oxygen monitor

All groups must have a similar percentage in each timepoint
Timepoint [1] 327946 0
Baseline and 1minute,3minutes ,5minutes ,10 minutes,20 minutes,30 minutes 40 minutes ,50 minutes,60 minutes after administration

Eligibility
Key inclusion criteria
minimum age 18 years old
ASA I patients
Ankle-Brachial Index (0,9-1,3)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients with known peripheral vascular disease, diabetes mellitus, Raynaud’s syndrome, systemic sclerosis, CREST syndrome or patients with any vasospastic disorder. cardio- vascular diseases

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
24/02/2016
Date of last participant enrolment
Anticipated
31/03/2017
Actual
31/03/2017
Date of last data collection
Anticipated
8/04/2017
Actual
4/04/2017
Sample size
Target
112
Accrual to date
Final
112
Recruitment outside Australia
Country [1] 8256 0
Spain
State/province [1] 8256 0
SEVILLE

Funding & Sponsors
Funding source category [1] 294575 0
University
Name [1] 294575 0
SEVILLE UNIVERSITY. PODIATRY DEPARTMENT
Country [1] 294575 0
Spain
Primary sponsor type
University
Name
PODIATRY DEPARTMENT. SEVILLE UNIVERSITY
Address
6, AVENZOAR STREET. POSTCODE 41009. SEVILLE. SPAIN
Country
Spain
Secondary sponsor category [1] 293442 0
None
Name [1] 293442 0
none
Address [1] 293442 0
none
Country [1] 293442 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296009 0
Comite de etica de la investigacion de los Hospitales Universitarios Virgen Macarena y Virgen del Rocio
Ethics committee address [1] 296009 0
1, Manuel Siurot street Postcode 41013 SEVILLE (SPAIN)
Ethics committee country [1] 296009 0
Spain
Date submitted for ethics approval [1] 296009 0
06/10/2014
Approval date [1] 296009 0
23/02/2016
Ethics approval number [1] 296009 0
0725-N-14

Summary
Brief summary
The primary purpose of the study is to establish if the latency time of anesthesia is conditioned by the use or not of epinephrine and if the use of epinephrine increase or decrease its latency time. The second purpose of the study is to establish a latency time of anesthesia of four commonly used agents (bupivacaine and lidocaine, with or without epinephrine).The Third purpose determine the safety of epinephrine use in toes-

Hypothesis: The adition of epinephrine to local anesthetics decrease the latency time of anesthesia
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1136 1136 0 0
/AnzctrAttachments/371543-0725-N-14.pdf (Ethics approval)
Attachments [2] 1137 1137 0 0
/AnzctrAttachments/371543-Anexo III.consentimiento.pdf (Participant information/consent)
Attachments [3] 1138 1138 0 0
/AnzctrAttachments/371543-Rta Cordoba-Gonzalez.pdf (Supplementary information)

Contacts
Principal investigator
Name 69230 0
Mr JESUS GONZALEZ BENITEZ
Address 69230 0
6, Avenzoar street 41009 Seville (Spain)

PODIATRY DEPARTMENT. SEVILLE UNIVERSITY
Country 69230 0
Spain
Phone 69230 0
+34696075441
Fax 69230 0
Email 69230 0
jesulus@gmail.com
Contact person for public queries
Name 69231 0
JESUS GONZALEZ BENITEZ
Address 69231 0
PODIATRY DEPARTMENT. SEVILLE UNIVERSITY

6, Avenzoar street 41009 Seville (Spain)
Country 69231 0
Spain
Phone 69231 0
+34696075441
Fax 69231 0
Email 69231 0
jesulus@gmail.com
Contact person for scientific queries
Name 69232 0
Dr Antonio Cordoba Fernandez
Address 69232 0
Avicena s/n, 41009 Sevilla (Spain)
School of Nursing, Physiotherapy and Podiatry of Seville University
Country 69232 0
Spain
Phone 69232 0
+34 954486539
Fax 69232 0
+34 954486527
Email 69232 0
acordoba@us.es

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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