Effect of a lidocaine patch in the reduction of the lower limb amputation pain.

Phase 1

• Conditions: ower limb amputation pain: phantom limb pain and primary/secondary scar hyperalgesia.; Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

• Registration Number: EUCTR2016-000864-41-BE
• Lead Sponsor: Centre Hospitalier Universitaire Brugmann

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-17
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

All above or below knee amputations in the first two months after surgery, after complete wound healing (no clips, no stitches, no seepage)
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 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

- individuals younger than 18 years old
- patients with history of central nervous system disease
- patients with history of major psychiatric disease (MMS<23/30, HADS <8/21)
- pregnancy
- known hypersensitivity to local anesthetics (lidocaine, bupivacaine, etidocaine, mepivacaine, prilocaine)
- skin irritation of the stump

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified