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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
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 Pain, Injections, Lidocaine, Healthy volunteers

Eligibility Criteria

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

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

First Posted
April 4, 2014
Last Updated
May 26, 2015
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
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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.
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Will Adjusting the pH of Lidocaine Reduce the Pain During Injection of Local Anaesthetic?

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