Inguinal Pain Clinical Trial
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.
| Status | Completed |
| Enrollment | 21 |
| Est. completion date | June 2012 |
| Est. primary completion date | June 2012 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Rigshospitalet | Copenhagen |
| Lead Sponsor | Collaborator |
|---|---|
| Rigshospitalet, Denmark |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | pain reduction with lidocaine patch | assessed the last three days in each treatment period | No |