Lidocaine Patch for Treatment of Persistent Inguinal Postherniorrhaphy Pain | NCT01443325 | Trialant
CompletedInterventionalPhase 3Updated Jun 22, 2012
Lidocaine Patch for Treatment of Persistent Inguinal Postherniorrhaphy Pain
ClinicalTrials.gov ID
NCT01443325
Lead Sponsor
Rigshospitalet, DenmarkOTHER
Overall Status
Completed
Study Type
Interventional
Phase
Phase 3
Enrollment
21Actual
Last Update Posted
Jun 22, 2012Estimated
Start Date
Sep 2011
Primary Completion Date
Jun 2012Actual
Completion Date
Jun 2012Actual
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.
Inguinal Pain
lidocaine patch
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
Male
Accepts Healthy Volunteers
No
Eligibility 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.