Text Size

Lidocaine Patch for Treatment of Persistent Inguinal Postherniorrhaphy Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joakim Bischoff, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01443325
First received: September 26, 2011
Last updated: June 21, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention Phase
Inguinal Pain
 Drug: lidocaine patch
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • pain reduction with lidocaine patch [ Time Frame: assessed the last three days in each treatment period ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: September 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lidocaine patch Drug: lidocaine patch
1 patch for 12 hours within each 24 hours period
Other Name: versatis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01443325

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

No publications provided

Responsible Party: Joakim Bischoff, Research fellow, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01443325     History of Changes
Other Study ID Numbers: H-2-2011-051
Study First Received: September 26, 2011
Last Updated: June 21, 2012
Health Authority: Denmark: Danish Medicines Agency
Denmark: Danish Dataprotection Agency

Keywords provided by Rigshospitalet, Denmark:
Persistent Postherniorrhaphy inguinal Pain

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 23, 2013