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

Rigshospitalet

Status and phase: Terminated; Phase 3

Conditions: Persistent Pain After Inguinal Herniotomy

Treatments: Drug: capsaicin patch (qutenza); Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01699854

2012-001540-22 (EudraCT Number)

H-4-2012-055

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

capsaicin patch

Active Comparator group

Treatment:

Drug: capsaicin patch (qutenza)

placebo patch

Placebo Comparator group

Treatment:

Drug: Placebo