Lidocaine Patch for Treatment of Persistent Inguinal Postherniorrhaphy Pain
- Registration Number
- NCT01443325
- Lead Sponsor
- Rigshospitalet, Denmark
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 21
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description lidocaine patch lidocaine patch -
- Primary Outcome Measures
Name Time Method pain reduction with lidocaine patch assessed the last three days in each treatment period
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Rigshospitalet
🇩🇰Copenhagen, Denmark