Capsaicin Patch 8 % for the Treatment of Persistent Pain After Inguinal Herniotomy

• Status: Terminated
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

Summary

In the present study the investigators intend to investigate analgesic and sensory effects of a capsaicin patch 8 %(Qutenza) in patients with severe post-herniotomy pain and sensory abnormalities in the skin.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rigshospitalet, Denmark
• Treatments: Capsaicin

Criteria

Inclusion Criteria:

• Patients ASA (American Society´s of Anesthesiology´s classification) scores I-III

• Severe post-herniotomy pain for more than six months and with severe pain (numerical rating scale [NRS] 0-10 points) during rest or during movement > 5.

Exclusion Criteria:

• History of an allergic reaction or intolerance to capsaicin or vehicle ingredients in the patches

• Severe cardiac impairment, e.g., NYHA (New York Heart Association) Class ≥ III

• Inflamed or injured skin at the application site

• Signs of cognitive impairment

• Known drug or ethanol abuse