Lidocaine Patch for Treatment of Persistent Inguinal Postherniorrhaphy Pain

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rigshospitalet, Denmark
• Treatments: Lidocaine

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.