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

Information source: Rigshospitalet, Denmark
ClinicalTrials.gov processed this data on August 20, 2015
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) score

Changes 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

Page last updated: August 20, 2015

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