Persistent Pain After Inguinal Herniotomy
Conditions
Brief 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.
Interventions
DRUGcapsaicin patch (qutenza)
DRUGPlacebo
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain change capsaicin vs. placebo patch treatment | Pain intensity assessed at baseline and at 1,2,3 months follow-up | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Changes in sleep (Sleep Interference Scale) score | — |
| Changes in AAS (Activities Assessment Scale) score | — |
| Changes in HADS (Hospital Anxiety and Depression Scale) score | — |
| Changes in QST (Quantitative sensory testing) | — |
| 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 | — |
| Changes in S-LANSS (Leeds self-assessment of neuropathic symptoms and signs) | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| interim analyses | — | An interim analysis evaluating pain change (SPID) for capsaicin patch vs. placebo treatment by an independent statistician following completion of 32 patients. |
Countries
Denmark
Outcome results
None listed