Almost 60% of patients suffer from phantom limb pain one year after surgery, whereas in the first month, 85% to 97% of patients experience phantom limb pain. IV. calcitonin in the early postoperative period was effective in phantom limb pain in one single double-blind, crossover study. Because of the lack of any confirmatory observation we are testing the hypothesis that calcitonin is effective in phantom limb pain prophylaxis. MedDRA version: 9.1 Level: LLT Classification code 10034804 Term:
Conditions
Interventions
Trade Name: Calcitonin Novartis
Product Name: Calcitonin Novartis
Pharmaceutical Form: Solution for infusion
Pharmaceutical form of the placebo: Intravenous infusion
Route of administration of the pla
Sponsors
Medical University of Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: patients undergoing elective amputation on the lower extremity age between 18 and 70 years 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: contraindication to calcitonin, age < 18 yr, patients undergoing further amputation during the follow up period hypocalcemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: occurrence of phantom limb pain on the 28th day postoperatively;Secondary Objective: occurrence of phantom limb pain on day 1, 4, 7 and after 3 months, consumption of the anti-neuropathic medication and morphine during the postoperative period.;Primary end point(s): Phantom limb pain on day 28 after surgery | — |
Countries
Austria
Outcome results
None listed