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NCT02107729 Clinical Trial

The Importance of Needle Gauge for Pain During Injection of Local Anaesthetic

Needlestick Injuries Clinical Trial

Official title:
The Importance of Needle Gauge for Pain During Injection of Local Anaesthetic

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02107729
Other study ID # 2013/2297B
Secondary ID
Status Completed
Phase N/A
First received April 4, 2014
Last updated July 28, 2016
Start date February 2014
Est. completion date June 2014

Study information
Verified date July 2016
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research Ethics
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Large needle gauge lidocaine injection
21 G
• Normal needle gauge lidocaine injection
23 G
• Small needle gauge lidocaine injection
27 G

Locations
Country Name City State
Norway Department of Neuroscience, NTNU Trondheim

Sponsors (2)
Lead Sponsor Collaborator
Norwegian University of Science and Technology St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Wågø KJ, Skarsvåg 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Pain Visual analog scale
Questionnaire		 60 seconds No
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Completed NCT02086292 - The Influence of Lidocaine Volume on Discomfort During Administration of Local Anesthetic N/A
Completed NCT02107742 - The Influence of Injection Speed on Pain During Administration of Local Anaesthetic. N/A
Completed NCT02107690 - The Influence of Lidocaine Temperature on Pain During Subcutaneous Administration N/A
Completed NCT02107716 - Will Adjusting the pH of Lidocaine Reduce the Pain During Injection of Local Anaesthetic? N/A