Status:
COMPLETED
Lidocaine Patch for Treatment of Persistent Inguinal Postherniorrhaphy Pain
Lead Sponsor:
Rigshospitalet, Denmark
Conditions:
Inguinal Pain
Eligibility:
MALE
18+ years
Phase:
PHASE3
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-herniorrhap...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01443325
Start Date
September 1 2011
End Date
June 1 2012
Last Update
June 22 2012
Active Locations (1)
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1
Rigshospitalet
Copenhagen, Denmark