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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
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Needlestick Injuries focused on measuring Injections, Pain, Healthy volunteers, Lidocaine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
April 4, 2014
Last Updated
July 28, 2016
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
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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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