Persistent Pain After Inguinal Herniotomy Clinical Trial
| Verified date | February 2014 |
| Source | Rigshospitalet, Denmark |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Denmark: Danish Health and Medicines Authority |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 50 |
| Est. completion date | September 2013 |
| Est. primary completion date | September 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Rigshospitalet | Copenhagen | Copenhagen Ø |
| Lead Sponsor | Collaborator |
|---|---|
| Rigshospitalet, Denmark |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | interim analyses | An interim analysis evaluating pain change (SPID) for capsaicin patch vs. placebo treatment by an independent statistician following completion of 32 patients. | No | |
| Primary | 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. ? SPID is then calculated as the difference in SPID between capsaicin and placebo treated patients. | Pain intensity assessed at baseline and at 1,2,3 months follow-up | No |
| Secondary | Changes in AAS (Activities Assessment Scale) score | No | ||
| Secondary | Changes in HADS (Hospital Anxiety and Depression Scale) score | No | ||
| Secondary | Changes in QST (Quantitative sensory testing) | No | ||
| Secondary | Changes in sleep (Sleep Interference Scale) score | No | ||
| Secondary | Changes in S-LANSS (Leeds self-assessment of neuropathic symptoms and signs) | No | ||
| Secondary | Changes in intraepidermal nerve fiber density | No | ||
| Secondary | 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 | No | ||
| Secondary | Changes in PCS (Pain Catastrophizing Scale) score | No |