Comparison of latency time of local anesthetics among four Commonly Used Agents in Digital Nerve Block

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616001610426
• Date of registration: 21/11/2016
• Prospective Registration: No
• Primary sponsor: PODIATRY DEPARTMENT. SEVILLE UNIVERSITY
• 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
• Date of first enrolment: 24/02/2016
• Target sample size: 112
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12616001610426.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Phase 3 / Phase 4

Countries of recruitment

Spain

Contacts

• Name: Mr JESUS GONZALEZ BENITEZ

• Name: Mr Dr Antonio Cordoba Fernandez

Key inclusion & exclusion criteria

Inclusion criteria: minimum age 18 years old
ASA I patients
Ankle-Brachial Index (0,9-1,3)
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


Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Drug indicated for toe surgery (ingrown toenail/onychocryptosis...);
Drug indicated for toe surgery (ingrown toenail/onychocryptosis...)

Anaesthesiology - Anaesthetics

Skin - Dermatological conditions

Intervention(s)

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

Primary Outcome(s)

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.[Baseline and every 10 seconds after intervention administration until participant has no pain.]

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)
.[Baseline and every 10 seconds after intervention administration until participant has no pain]

Secondary Outcome(s)

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[Baseline and 1minute,3minutes ,5minutes ,10 minutes,20 minutes,30 minutes 40 minutes ,50 minutes,60 minutes after administration ]

Secondary ID(s)

NONE

Source(s) of Monetary Support

SEVILLE UNIVERSITY. PODIATRY DEPARTMENT

Ethics review

Status: Approved
Approval date:
Contact:

Comite de etica de la investigacion de los Hospitales Universitarios Virgen Macarena y Virgen del Rocio