NCT02107729

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 8, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

July 29, 2016

Status Verified

July 1, 2016

Enrollment Period

4 months

First QC Date

April 4, 2014

Last Update Submit

July 28, 2016

Conditions

Needlestick Injuries

Keywords

InjectionsPainHealthy volunteersLidocaine

Outcome Measures

Primary Outcomes (1)

  • Pain

    1. Visual analog scale 2. Questionnaire

    60 seconds

Study Arms (3)

Needle gauge small

EXPERIMENTAL

injection needle 23 G

Procedure: Large needle gauge lidocaine injectionProcedure: Normal needle gauge lidocaine injectionProcedure: Small needle gauge lidocaine injection

Needle gauge normal

EXPERIMENTAL

injection needle 25 G

Procedure: Large needle gauge lidocaine injectionProcedure: Normal needle gauge lidocaine injectionProcedure: Small needle gauge lidocaine injection

Needle gauge large

EXPERIMENTAL

injection needle 27 G

Procedure: Large needle gauge lidocaine injectionProcedure: Normal needle gauge lidocaine injectionProcedure: Small needle gauge lidocaine injection

Interventions

Large needle gauge lidocaine injectionPROCEDURE

21 G

Needle gauge largeNeedle gauge normalNeedle gauge small
Normal needle gauge lidocaine injectionPROCEDURE

23 G

Needle gauge largeNeedle gauge normalNeedle gauge small
Small needle gauge lidocaine injectionPROCEDURE

27 G

Needle gauge largeNeedle gauge normalNeedle gauge small

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65 years

You may not qualify if:

  • Kidney, heart or liver disease
  • Eczema or psoriasis on injection site
  • Neuropathy
  • Regular use of painkillers
  • Hypersensitivity of Lidocaine
  • Pregnancy
  • Diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neuroscience, NTNU

Trondheim, Norway

Location

Related Publications (1)

  • 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.

    PMID: 26595751RESULT

MeSH Terms

Conditions

Needlestick InjuriesPain

Condition Hierarchy (Ancestors)

Wounds, StabWounds, PenetratingWounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Vilhjalmur Finsen, Prof md

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2014

First Posted

April 8, 2014

Study Start

February 1, 2014

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

July 29, 2016

Record last verified: 2016-07

Locations

NO(1)