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Trial record 66 of 1046 for:    scale | Norway

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

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ClinicalTrials.gov Identifier: NCT02107716
Recruitment Status : Completed
First Posted : April 8, 2014
Last Update Posted : May 27, 2015
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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.

Condition or disease Intervention/treatment Phase
Needlestick Injuries Procedure: Lidocaine injection with bicarbonate Procedure: lidocaine injection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Will Adjusting the pH of Lidocaine Reduce the Pain During Injection of Local Anaesthetic?
Study Start Date : February 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Bicarbonate
Each participant will receive two lidocaine injections on the abdomen with different pH
Procedure: Lidocaine injection with bicarbonate
bicarbonate added to change pH

Procedure: lidocaine injection
Lidocaine injection with pH unchanged




Primary Outcome Measures :
  1. Pain [ Time Frame: 60 seconds ]
    1. Visual Analog Scale 0-100 mm
    2. Questionnaire



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02107716


Locations
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Norway
Department of Neuroscience, NTNU
Trondheim, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
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Study Director: Vilhjalmur Finsen, Prof md Norwegian University of Science and Technology

Publications of Results:
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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT02107716     History of Changes
Other Study ID Numbers: 2013/2297A
First Posted: April 8, 2014    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015
Keywords provided by Norwegian University of Science and Technology:
Pain
Injections
Lidocaine
Healthy volunteers
Additional relevant MeSH terms:
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Needlestick Injuries
Wounds, Stab
Wounds, Penetrating
Wounds and Injuries
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action