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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02086292
Other study ID # 2013/2297D
Secondary ID
Status Completed
Phase N/A
First received March 11, 2014
Last updated September 15, 2016
Start date February 2014
Est. completion date June 2014

Study information

Verified date September 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

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.


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.


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

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)

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:
2 ml 1% Lidocaine

1 ml 2% Lidocaine


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)

Ballo S, Hjelseng T, Tangen LF, Lundbom JS, Skarsvåg 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary pain visual analog scale 0-100mm
questionnaire
60 seconds No
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