Will Adjusting the pH of Lidocaine Reduce the Pain During Injection of Local Anaesthetic?
Primary Purpose
Needlestick Injuries
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Lidocaine injection with bicarbonate
lidocaine injection
Sponsored by
About this trial
This is an interventional treatment trial for Needlestick Injuries focused on measuring Pain, Injections, Lidocaine, Healthy volunteers
Eligibility Criteria
Inclusion Criteria: fyll inn
- 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 Type
Experimental
Arm Label
Bicarbonate
Arm Description
Each participant will receive two lidocaine injections on the abdomen with different pH
Outcomes
Primary Outcome Measures
Pain
Visual Analog Scale 0-100 mm
Questionnaire
Secondary Outcome Measures
Full Information
NCT ID
NCT02107716
First Posted
April 4, 2014
Last Updated
May 26, 2015
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02107716
Brief Title
Will Adjusting the pH of Lidocaine Reduce the Pain During Injection of Local Anaesthetic?
Official Title
Will Adjusting the pH of Lidocaine Reduce the Pain During Injection of Local Anaesthetic?
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
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 adjusting the pH of lidocaine on pain during subcutaneous injection. Each participant will receive two injections on the abdomen with different pH. After each injection, the subject will be asked to evaluate the pain on a Visual analog scale (0-100 mm). It is anticipated that the pain decreases with increasing pH. The aim of the 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
Pain, Injections, Lidocaine, Healthy volunteers
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bicarbonate
Arm Type
Experimental
Arm Description
Each participant will receive two lidocaine injections on the abdomen with different pH
Intervention Type
Procedure
Intervention Name(s)
Lidocaine injection with bicarbonate
Intervention Description
bicarbonate added to change pH
Intervention Type
Procedure
Intervention Name(s)
lidocaine injection
Intervention Description
Lidocaine injection with pH unchanged
Primary Outcome Measure Information:
Title
Pain
Description
Visual Analog Scale 0-100 mm
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: fyll inn
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
25991379
Citation
Skarsvag TI, Wago KJ, Tangen LF, Lundbom JS, Hjelseng T, Ballo S, Finsen V. Does adjusting the pH of lidocaine reduce pain during injection? J Plast Surg Hand Surg. 2015 Oct;49(5):265-267. doi: 10.3109/2000656X.2015.1047780. Epub 2015 May 19.
Results Reference
result
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Will Adjusting the pH of Lidocaine Reduce the Pain During Injection of Local Anaesthetic?
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