Inguinal Pain
Conditions
Keywords
Persistent Postherniorrhaphy inguinal Pain
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.
Interventions
DRUGlidocaine patch
1 patch for 12 hours within each 24 hours period
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pain reduction with lidocaine patch | assessed the last three days in each treatment period |
Countries
Denmark
Outcome results
None listed