Will Adjusting the pH of Lidocaine Reduce the Pain During... | NCT02107716

Studies
Will Adjusting the pH of Lidocaine Reduce the Pain During Injection of Local Anaesthetic?

NCT02107716

Sponsor

Norwegian University of Science and Technology

Status

Completed

Last Update Posted

May 27, 2015Estimated

Enrollment

32Actual

Phase

Not Applicable

Conditions

Needlestick Injuries

Interventions

Lidocaine injection with bicarbonate
lidocaine injection

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2014

Primary Completion Date

Jun 2014Actual

Completion Date

Jun 2014Actual

First Submitted Date

Apr 4, 2014

First Submission Date that Met QC Criteria

Apr 4, 2014

First Posted Date

Apr 8, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 26, 2015

Last Update Posted Date

May 27, 2015Estimated

Name	Class
St. Olavs Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bicarbonate	Experimental	Each participant will receive two lidocaine injections on the abdomen with different pH	Procedure: Lidocaine injection with bicarbonate Procedure: lidocaine injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lidocaine injection with bicarbonate	Procedure	bicarbonate added to change pH	Bicarbonate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain	Visual Analog Scale 0-100 mm Questionnaire	60 seconds

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vilhjalmur Finsen, Prof md	Norwegian University of Science and Technology	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Neuroscience, NTNU		Trondheim			Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25991379	Result	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.

ID	Term
D014951	Wounds, Stab
D014950	Wounds, Penetrating
D014947	Wounds and Injuries
D009461	Neurologic Manifestations

ID	Term
D008012	Lidocaine
D001639	Bicarbonates

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814

ID	Term
D016602	Needlestick Injuries
D010146	Pain