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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Persistent Pain After Inguinal Herniotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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capsaicin patch

Group Type ACTIVE_COMPARATOR

capsaicin patch (qutenza)

Intervention Type DRUG

placebo patch

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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capsaicin patch (qutenza)

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No