CHRONIC PAIN AFTER INGUINAL HERNIOTOMY MedDRA version: 14.1 Level: LLT Classification code 10049475 Term: Chronic pain System Organ Class: 10018065 - General disorders and administration site conditions
Conditions
Interventions
Trade Name: Qutenza
Pharmaceutical Form: Cutaneous patch
INN or Proposed INN: CAPSAICIN
CAS Number: 404-86-4
Other descriptive name: CAPSAICIN
Pharmaceutical form of the placebo: Cutaneous patch
Route
Sponsors
Mads Werner
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Males > 18 yrs, ASA (American Society´s of Anesthesiology´s classification) scores I-III, with severe postherniotomy pain for more than six months and with average daily pain intensities (numerical rating scale [NRS] 0–10 points) during rest or during movement > 5. Concomitant analgesics and adjuvant analgesics will be permitted, provided that subjects have received a stable regimen for at least four weeks prior to study entry. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: History of an allergic reaction or intolerance to capsaicin or vehicle ingredients in the patches; use of class I antiarrhythmic drugs (e.g., tocainide and mexiletine); severe cardiac impairment, inflamed or injured skin at the application site; known severe hepatic disorder, known severe renal impairment, breastfeeding women, signs of cognitive impairment or known drug or ethanol abuse during the last 2 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to investigate analgesic and sensory effects of a capsaicin patch (Qutenza) in patients with severe postherniotomy pain and sensory abnormalities in the skin.;Secondary Objective: Investigate changes after treatment in Hospital Anxiety and Depression Scale (HADS), Pain Catastrophizing Scale (PCS), need of rescue medication (paracetamol), patient preference and Sleep Interference Scale (SIS);Primary end point(s): Primary outcome: 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 during each of the study´s phases: Baseline (0SPI3d), 1 month (1SPI3d), 2 month (2SPI3d), and 3 month (3SPI3d). The summed pain intensity differences (SPID) are calculated: • 0SPI3d - 1SPI3d= SPID0-1 • 0SPI3d - 2SPI3d= SPID0-2 • 0SPI3d - 3SPI3d= SPID0-3 The primary outcome measure is the maximum difference between the summed pain intensity differences for the phases: Baseline, 1 month, 2 month or 3 month. ? SPID is then calculated as the difference in SPID between capsaicin and inactive placebo treated patients. Identical calculations are made for patients with thermal hypoesthesia (? SPIDhypo) and thermal normo/hyperesthesia (? SPIDnormo/hyper). ;Timepoint(s) of evaluation of this end point: Pain intensity (numerical rating scale [NRS] 0–10 points) is registered twice daily | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Changes in Hospital Anxiety and Depression Scale (HADS), Pain Catastrophizing Scale (PCS), need of rescue medication (paracetamol), patient preference and Sleep Interference Scale (SIS);Timepoint(s) of evaluation of this end point: Before treatment and each month during the 3 months follow-up after treatment | — |
Countries
Denmark
Contacts
Public ContactTværfagligt smertecenter
Rigshospitalet
Outcome results
None listed