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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014