Capsaicin Patch 8 % for the Treatment of Persistent Pain After Inguinal Herniotomy
Information source: Rigshospitalet, Denmark
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Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Persistent Pain After Inguinal Herniotomy
Intervention: capsaicin patch (qutenza) (Drug); Placebo (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: Rigshospitalet, Denmark
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.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Pain change capsaicin vs. placebo patch treatment
Secondary outcome: Changes in AAS (Activities Assessment Scale) scoreChanges in HADS (Hospital Anxiety and Depression Scale) score Changes in QST (Quantitative sensory testing) Changes in sleep (Sleep Interference Scale) score Changes in S-LANSS (Leeds self-assessment of neuropathic symptoms and signs) Changes in intraepidermal nerve fiber density Subgroup analysis for pain change(summed pain intensity differences (SPID) capsaicin patch vs. placebo are made for patients with thermal hypoesthesia and thermal normo/hyperesthesia Changes in PCS (Pain Catastrophizing Scale) score
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Rigshospitalet, Copenhagen, Copenhagen Ø 2100, Denmark
Additional Information
Starting date: August 2012
Last updated: February 25, 2014
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