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NCT02107716 Clinical Trial

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

Needlestick Injuries Clinical Trial

Official title:
Will Adjusting the pH of Lidocaine Reduce the Pain During Injection of Local Anaesthetic?

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02107716
Other study ID # 2013/2297A
Secondary ID
Status Completed
Phase N/A
First received April 4, 2014
Last updated May 26, 2015
Start date February 2014
Est. completion date June 2014

Study information
Verified date May 2015
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

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.

Recruitment information / eligibility
Status Completed
Enrollment 32
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: 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Lidocaine injection with bicarbonate
bicarbonate added to change pH
• lidocaine injection
Lidocaine injection with pH unchanged

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)

Skarsvåg TI, Wågø 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 May 19:1-3. [Epub ahead of print] — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Pain Visual Analog Scale 0-100 mm
Questionnaire		 60 seconds No
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Completed NCT00536289 - Blunt Needles do Not Reduce Needlestick Injuries to Doctors During Suturing After Child-Birth N/A
Completed NCT02107690 - The Influence of Lidocaine Temperature on Pain During Subcutaneous Administration N/A
Completed NCT02107742 - The Influence of Injection Speed on Pain During Administration of Local Anaesthetic. N/A
Completed NCT02086292 - The Influence of Lidocaine Volume on Discomfort During Administration of Local Anesthetic N/A
Completed NCT02107729 - The Importance of Needle Gauge for Pain During Injection of Local Anaesthetic N/A