Rigshospitalet
Copenhagen, Denmark
Completed
NCT Number: NCT01443325
Lidocaine Patch for Treatment of Persistent Inguinal Postherniorrhaphy Pain
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
Male
Study type
Interventional
Phase
Phase 3
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Lidocaine patch
Drug1 patch for 12 hours within each 24 hours period
Other names: versatis
Primary outcomes
-
pain reduction with lidocaine patch
Time frame: assessed the last three days in each treatment period
Sponsors and collaborators
Lead sponsor
Rigshospitalet, Denmark
Other
Registry information
Important dates
- Study start
- 2011
- Primary completion
- 2012
- Study completion
- 2012
- First posted
- Sep 29, 2011
- Registry last updated
- Jun 22, 2012
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.