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The Influence of Lidocaine Volume on Discomfort During Administration of Local Anesthetic

Primary Purpose

Needlestick Injuries

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
2 ml 1% Lidocaine
1 ml 2% Lidocaine
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, Lidocaine, Pain, Healthy volunteers

Eligibility Criteria

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

Inclusion Criteria:

  • age 18 - 65

Exclusion Criteria:

  • regular use of analgesics
  • known hypersensitivity of local anaesthetic
  • renal-, heart- or liver disease
  • known peripheral neuropathy or diabetes mellitus
  • local infection on injection site
  • circulation disorders in upper extremities (e.g. Raynaud´s phenomenon)

Sites / Locations

  • Department of neuroscience, NTNU

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

2 milliliter lidocaine

1 milliliter lidocaine

Arm Description

2 ml 1% Lidocaine in one ring finger, 1 ml 2% Lidocaine in the other ring finger

1 ml 1% Lidocaine in one ring finger, 2 ml 2% Lidocaine in the other ring finger

Outcomes

Primary Outcome Measures

pain
visual analog scale 0-100mm questionnaire

Secondary Outcome Measures

Full Information

First Posted
March 11, 2014
Last Updated
September 15, 2016
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02086292
Brief Title
The Influence of Lidocaine Volume on Discomfort During Administration of Local Anesthetic
Official Title
The Influence of Lidocaine Volume on Discomfort During Administration of Local Anesthetic
Study Type
Interventional

2. Study Status

Record Verification Date
September 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
The aim of the study is to find a simple method for pain reduction that can be used in clinical practice when administering digital nerve block with a single subcutaneous injection. It will be investigated whether a smaller volume of lidocaine can decrease pain during injection.
Detailed Description
Healthy volunteers will receive a single subcutaneous injection digital nerve block at the base of each ring finger. 2ml 1% lidocaine in one of the fingers, and 1 ml 2% lidocaine in the other. After each injection, the subject will be asked to evaluate the pain on a visual analog scale (0-100 mm). Additionally the sensibility will be tested with a Semmes-Weinstein monofilament, to evaluate if the different methods achieve desired anesthetic effect.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Needlestick Injuries
Keywords
Injections, Lidocaine, Pain, Healthy volunteers

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
2 milliliter lidocaine
Arm Type
Experimental
Arm Description
2 ml 1% Lidocaine in one ring finger, 1 ml 2% Lidocaine in the other ring finger
Arm Title
1 milliliter lidocaine
Arm Type
Experimental
Arm Description
1 ml 1% Lidocaine in one ring finger, 2 ml 2% Lidocaine in the other ring finger
Intervention Type
Procedure
Intervention Name(s)
2 ml 1% Lidocaine
Intervention Type
Procedure
Intervention Name(s)
1 ml 2% Lidocaine
Primary Outcome Measure Information:
Title
pain
Description
visual analog scale 0-100mm 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 Exclusion Criteria: regular use of analgesics known hypersensitivity of local anaesthetic renal-, heart- or liver disease known peripheral neuropathy or diabetes mellitus local infection on injection site circulation disorders in upper extremities (e.g. Raynaud´s phenomenon)
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
27595956
Citation
Ballo S, Hjelseng T, Tangen LF, Lundbom JS, Skarsvag T, Finsen V. The Influence of Injected Volume on Discomfort During Administration of Digital Block. J Hand Surg Asian Pac Vol. 2016 Oct;21(3):369-73. doi: 10.1142/S2424835516500363.
Results Reference
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The Influence of Lidocaine Volume on Discomfort During Administration of Local Anesthetic

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