NCT02107716

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

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
2 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 8, 2014

Completed
2 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

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

4 months

First QC Date

April 4, 2014

Last Update Submit

May 26, 2015

Conditions

Needlestick Injuries

Keywords

PainInjectionsLidocaineHealthy volunteers

Outcome Measures

Primary Outcomes (1)

  • Pain

    1. Visual Analog Scale 0-100 mm 2. Questionnaire

    60 seconds

Study Arms (1)

Bicarbonate

EXPERIMENTAL

Each participant will receive two lidocaine injections on the abdomen with different pH

Procedure: Lidocaine injection with bicarbonateProcedure: lidocaine injection

Interventions

Lidocaine injection with bicarbonatePROCEDURE

bicarbonate added to change pH

Bicarbonate
lidocaine injectionPROCEDURE

Lidocaine injection with pH unchanged

Bicarbonate

Eligibility Criteria

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

You may qualify if:

  • Age 18-65 years

You may not qualify if:

  • Kidney, heart or liver disease
  • Eczema or psoriasis on injection site
  • Neuropathy
  • Regular use of painkillers
  • Hypersensitivity of Lidocaine
  • Pregnancy
  • Diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neuroscience, NTNU

Trondheim, Norway

Location

Related Publications (1)

  • 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.

    PMID: 25991379RESULT

MeSH Terms

Conditions

Needlestick InjuriesPain

Interventions

LidocaineBicarbonates

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCarbonatesCarbonic AcidCarbon Compounds, InorganicInorganic ChemicalsAnionsIonsElectrolytes

Study Officials

  • Vilhjalmur Finsen, Prof md

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2014

First Posted

April 8, 2014

Study Start

February 1, 2014

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations

NO(1)