The Importance of Needle Gauge for Pain During Injection of Local Anaesthetic
Primary Purpose
Needlestick Injuries
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Large needle gauge lidocaine injection
Normal needle gauge lidocaine injection
Small needle gauge lidocaine injection
Sponsored by
About this trial
This is an interventional treatment trial for Needlestick Injuries focused on measuring Injections, Pain, Healthy volunteers, Lidocaine
Eligibility Criteria
Inclusion Criteria:
- Age 18-65 years
Exclusion Criteria:
- Kidney, heart or liver disease
- Eczema or psoriasis on injection site
- Neuropathy
- Regular use of painkillers
- Hypersensitivity of Lidocaine
- Pregnancy
- Diabetes
Sites / Locations
- Department of Neuroscience, NTNU
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Needle gauge small
Needle gauge normal
Needle gauge large
Arm Description
injection needle 23 G
injection needle 25 G
injection needle 27 G
Outcomes
Primary Outcome Measures
Pain
Visual analog scale
Questionnaire
Secondary Outcome Measures
Full Information
NCT ID
NCT02107729
First Posted
April 4, 2014
Last Updated
July 28, 2016
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02107729
Brief Title
The Importance of Needle Gauge for Pain During Injection of Local Anaesthetic
Official Title
The Importance of Needle Gauge for Pain During Injection of Local Anaesthetic
Study Type
Interventional
2. Study Status
Record Verification Date
July 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
This study will investigate the influence of needle gauge on pain during injection of local anaesthetic. Healthy volunteers will be recruited, who will each receive three injections with either 21G, 23G or 27G subcutaneously on the abdomen. After each injection, the participants will be asked to evaluate the pain on a Visual analog scale (0-100 mm). It is anticipated that the pain will decrease with decreasing thickness of the needle. The aim of this study is to find a simple method for pain reduction that can be used in clinical practice.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Needlestick Injuries
Keywords
Injections, Pain, Healthy volunteers, Lidocaine
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
Needle gauge small
Arm Type
Experimental
Arm Description
injection needle 23 G
Arm Title
Needle gauge normal
Arm Type
Experimental
Arm Description
injection needle 25 G
Arm Title
Needle gauge large
Arm Type
Experimental
Arm Description
injection needle 27 G
Intervention Type
Procedure
Intervention Name(s)
Large needle gauge lidocaine injection
Intervention Description
21 G
Intervention Type
Procedure
Intervention Name(s)
Normal needle gauge lidocaine injection
Intervention Description
23 G
Intervention Type
Procedure
Intervention Name(s)
Small needle gauge lidocaine injection
Intervention Description
27 G
Primary Outcome Measure Information:
Title
Pain
Description
Visual analog scale
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 years
Exclusion Criteria:
Kidney, heart or liver disease
Eczema or psoriasis on injection site
Neuropathy
Regular use of painkillers
Hypersensitivity of Lidocaine
Pregnancy
Diabetes
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
26595751
Citation
Wago KJ, Skarsvag TI, Lundbom JS, Tangen LF, Ballo S, Hjelseng T, Finsen V. The importance of needle gauge for pain during injection of lidocaine. J Plast Surg Hand Surg. 2016;50(2):115-8. doi: 10.3109/2000656X.2015.1111223. Epub 2015 Nov 23.
Results Reference
result
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The Importance of Needle Gauge for Pain During Injection of Local Anaesthetic
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