Amputation of Lower Limb
Conditions
Brief summary
To investigate whether gabapentin can prevent phantom and stump pain after amputation.
Interventions
DRUGGabapentin
Sponsors
Pfizer
Danish Pain Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1\. Amputation of crus or femur
Exclusion criteria
1. Patients who cannot cooperate 2. Fertile women without sufficient contraceptives 3. Allergy to gabapentin 4. Earlier amputation of the same limb except toes 5. Serious lever, kidney, cardiac, respiratory, haematological disease.-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measures: | — |
| Number of patients with phantom and stump pain 30 days and 6 months after amputation | — |
| Average intensity of stump and phantom pain 30 days and 6 months after amputation | — |
Secondary
| Measure | Time frame |
|---|---|
| Concurrent pain medication at day 7, 14 and 30, and 3 and 6 months | — |
| Secondary outcome measures: | — |
| Brush evoked allodynia, wind up like pain to repetitive pinprick, pressure pain threshold at day 14 and 30. | — |
| Prevalence and severity of phantom and stump pain at controls day 7, 14 and 30, and 3 and 6 months | — |
| McGill Pain Questionnaire day 7, 14 and 30, and 3 and 6 months | — |
Countries
Denmark
Outcome results
None listed