The Influence of Lidocaine Volume on Discomfort During Administration of Local Anesthetic
Primary Purpose
Needlestick Injuries
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
2 ml 1% Lidocaine
1 ml 2% Lidocaine
Sponsored by
About this trial
This is an interventional treatment trial for Needlestick Injuries focused on measuring Injections, Lidocaine, Pain, Healthy volunteers
Eligibility Criteria
Inclusion Criteria:
- age 18 - 65
Exclusion Criteria:
- regular use of analgesics
- known hypersensitivity of local anaesthetic
- renal-, heart- or liver disease
- known peripheral neuropathy or diabetes mellitus
- local infection on injection site
- circulation disorders in upper extremities (e.g. Raynaud´s phenomenon)
Sites / Locations
- Department of neuroscience, NTNU
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
2 milliliter lidocaine
1 milliliter lidocaine
Arm Description
2 ml 1% Lidocaine in one ring finger, 1 ml 2% Lidocaine in the other ring finger
1 ml 1% Lidocaine in one ring finger, 2 ml 2% Lidocaine in the other ring finger
Outcomes
Primary Outcome Measures
pain
visual analog scale 0-100mm
questionnaire
Secondary Outcome Measures
Full Information
NCT ID
NCT02086292
First Posted
March 11, 2014
Last Updated
September 15, 2016
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02086292
Brief Title
The Influence of Lidocaine Volume on Discomfort During Administration of Local Anesthetic
Official Title
The Influence of Lidocaine Volume on Discomfort During Administration of Local Anesthetic
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study is to find a simple method for pain reduction that can be used in clinical practice when administering digital nerve block with a single subcutaneous injection. It will be investigated whether a smaller volume of lidocaine can decrease pain during injection.
Detailed Description
Healthy volunteers will receive a single subcutaneous injection digital nerve block at the base of each ring finger. 2ml 1% lidocaine in one of the fingers, and 1 ml 2% lidocaine in the other. After each injection, the subject will be asked to evaluate the pain on a visual analog scale (0-100 mm). Additionally the sensibility will be tested with a Semmes-Weinstein monofilament, to evaluate if the different methods achieve desired anesthetic effect.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Needlestick Injuries
Keywords
Injections, Lidocaine, Pain, Healthy volunteers
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2 milliliter lidocaine
Arm Type
Experimental
Arm Description
2 ml 1% Lidocaine in one ring finger, 1 ml 2% Lidocaine in the other ring finger
Arm Title
1 milliliter lidocaine
Arm Type
Experimental
Arm Description
1 ml 1% Lidocaine in one ring finger, 2 ml 2% Lidocaine in the other ring finger
Intervention Type
Procedure
Intervention Name(s)
2 ml 1% Lidocaine
Intervention Type
Procedure
Intervention Name(s)
1 ml 2% Lidocaine
Primary Outcome Measure Information:
Title
pain
Description
visual analog scale 0-100mm
questionnaire
Time Frame
60 seconds
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age 18 - 65
Exclusion Criteria:
regular use of analgesics
known hypersensitivity of local anaesthetic
renal-, heart- or liver disease
known peripheral neuropathy or diabetes mellitus
local infection on injection site
circulation disorders in upper extremities (e.g. Raynaud´s phenomenon)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vilhjalmur Finsen, prof md
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
Department of neuroscience, NTNU
City
Trondheim
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
27595956
Citation
Ballo S, Hjelseng T, Tangen LF, Lundbom JS, Skarsvag T, Finsen V. The Influence of Injected Volume on Discomfort During Administration of Digital Block. J Hand Surg Asian Pac Vol. 2016 Oct;21(3):369-73. doi: 10.1142/S2424835516500363.
Results Reference
result
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The Influence of Lidocaine Volume on Discomfort During Administration of Local Anesthetic
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