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Lidocaine Patch for Treatment of Persistent Inguinal Postherniorrhaphy Pain

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ClinicalTrials.gov Identifier: NCT01443325
Recruitment Status : Completed
First Posted : September 29, 2011
Last Update Posted : June 22, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
In the present placebo-controlled cross-over study the researchers intend to investigate analgesic and sensory effects of a lidocaine patch in patients with severe persistent inguinal post-herniorrhaphy pain.

Condition or disease Intervention/treatment Phase
Inguinal Pain Drug: lidocaine patch Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : September 2011
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: lidocaine patch Drug: lidocaine patch
1 patch for 12 hours within each 24 hours period
Other Name: versatis


Outcome Measures

Primary Outcome Measures :
  1. pain reduction with lidocaine patch [ Time Frame: assessed the last three days in each treatment period ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males > 18 yrs
  • ASA (American Society´s of Anesthesiology´s classification) scores I-III, with severe Pain for more than six months and with average daily pain intensities (numerical rating scale [NRS] 0-10 points) during rest or during movement > 6.

Exclusion Criteria:

  • History of an allergic reaction or intolerance to amide local anesthetics or vehicle ingredients in the patches
  • Use of class I antiarrhythmic drugs (e.g., tocainide and mexiletine)
  • Severe cardiac impairment, e.g., NYHA (New York Heart Association) Class ≥ III
  • Inflamed or injured skin at the application site
  • Known severe hepatic disorder (Child-Pugh score > 6)
  • Known severe renal impairment, (creatinine clearance < 30 mL/min)
  • Signs of cognitive impairment or known drug or ethanol abuse during the last 2 years.
Contacts and Locations

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): NCT01443325


Locations
Denmark
Rigshospitalet
Copenhagen, Denmark
Sponsors and Collaborators
Rigshospitalet, Denmark
More Information

Responsible Party: Joakim Bischoff, Research fellow, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01443325     History of Changes
Other Study ID Numbers: H-2-2011-051
First Posted: September 29, 2011    Key Record Dates
Last Update Posted: June 22, 2012
Last Verified: June 2012

Keywords provided by Joakim Bischoff, Rigshospitalet, Denmark:
Persistent Postherniorrhaphy inguinal Pain

Additional relevant MeSH terms:
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