Lidocaine Patch for Treatment of Persistent Inguinal Postherniorrhaphy Pain

Rigshospitalet

Status and phase

Completed

Phase 3

Conditions

Inguinal Pain

Treatments

Drug: lidocaine patch

Study type

Interventional

Funder types

Other

Identifiers

NCT01443325

H-2-2011-051

Details and patient eligibility

About

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.

Enrollment

21 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.