NCT02086292

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.

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
1 month until next milestone

First Submitted

Initial submission to the registry

March 11, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 13, 2014

Completed
3 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

September 16, 2016

Status Verified

September 1, 2016

Enrollment Period

4 months

First QC Date

March 11, 2014

Last Update Submit

September 15, 2016

Conditions

Needlestick Injuries

Keywords

InjectionsLidocainePainHealthy volunteers

Outcome Measures

Primary Outcomes (1)

  • pain

    1. visual analog scale 0-100mm 2. questionnaire

    60 seconds

Study Arms (2)

2 milliliter lidocaine

EXPERIMENTAL

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

Procedure: 2 ml 1% Lidocaine

1 milliliter lidocaine

EXPERIMENTAL

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

Procedure: 1 ml 2% Lidocaine

Interventions

2 ml 1% LidocainePROCEDURE
2 milliliter lidocaine
1 ml 2% LidocainePROCEDURE
1 milliliter lidocaine

Eligibility Criteria

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

You may qualify if:

  • age 18 - 65

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of neuroscience, NTNU

Trondheim, Norway

Location

Related Publications (1)

  • 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.

    PMID: 27595956RESULT

MeSH Terms

Conditions

Needlestick InjuriesPain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

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

March 11, 2014

First Posted

March 13, 2014

Study Start

February 1, 2014

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

September 16, 2016

Record last verified: 2016-09

Locations

NO(1)