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

Onset time of anesthesia in local anesthetics with or without epinephrine. A Randomized double blind clinical trial in healthy volunteers

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616001610426

Enrollment

112

Registered

2016-11-21

Start date

2016-02-24

Completion date

2017-03-31

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

Interventions

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)

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Outcome results