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

Phase 3TerminatedNCT01699854

Rigshospitalet, Denmark50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Persistent Pain After Inguinal Herniotomy

Interventions

capsaicin patch (qutenza)DRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (1)

Rigshospitalet

Copenhagen, Copenhagen Ø, Denmark

Outcomes

Primary Outcomes

Pain change capsaicin vs. placebo patch treatment

Summed pain intensity (SPI) is calculated as median pain intensities at rest, during transition from the supine lying to the standing erect position, and auto-palpation twice each day for the last 3 days at baseline and at 1 months, 2 months and 3 months during follow-up. The primary outcome measure is the maximum difference between the summed pain intensity differences (SPID) for the phases: Baseline, 1 month, 2 month or 3 month. Δ SPID is then calculated as the difference in SPID between capsaicin and placebo treated patients.

Time frame: Pain intensity assessed at baseline and at 1,2,3 months follow-up

Secondary Outcomes

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

Data from ClinicalTrials.gov

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