Lower limb amputation pain: phantom limb pain and primary/secondary scar hyperalgesia.
Conditions
Interventions
Trade Name: Versatis 5%
Pharmaceutical Form: Cutaneous patch
INN or Proposed INN: LIDOCAINE
CAS Number: 137-58-6
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentrati
Sponsors
Centre Hospitalier Universitaire Brugmann
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Not applicable;Primary end point(s): - Reported overall daily pain intensity (stump, scar and PLP) rated on a 0 to 100 visual analogue scale with anchors of 0 (no pain) and 100 (worst pain ever experienced). - DN4 questionnaire (screening for neuropathic pain) - Neuropathic Pain Symptom Inventory (NPSI) - Short-Form McGill Pain Questionnaire sentitive to the effects of pain treatment - Quality of life: SF-36 questionnaire - Pittsburgh Sleep Quality Index;Timepoint(s) of evaluation of this end point: - Reported overall daily pain intensity: every day, starting from J-7 before patch placement till 6 weeks after patch placement. - DN4: at baseline (J-7 before placement of the patch) - NPSI: at baseline (J-7 before placement of the patch), one day, 6 weeks and 6 month after patch placement - McGill: at baseline (J-7 before placement of the patch), one day and 6 weeks after patch placement -SF-36: at baseline (J-7 before placement of the patch), 6 weeks and 6 month after patch placement - Pittsburgh Sleep Quality Index; at baseline (J-7 before placement of the patch), 6 weeks and 6 month after patch placement.;Main Objective: The main objective of the trial is to investigate if a lidocaine patch 5% is effective for reducing PLP and primary/secondary scar hyperalgesia. The hypothesis is that persistent peripheral nociceptive input from the stump after surgery may drive maladaptive cortical reorganization leading to chronic central pain and thus promote chronic phantom limb pain. Treating scar hyperalgesia on the stump with topical lidocaine may reduce the activity of peripheral nociceptive afferents and thus decrease the likehood of developing persistent phantom limb pain. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Delay of dress of provisory prosthesis (number of days between surgery and delivery of temporary prosthesis) - Delay of dress of provisory prosthesis (number of days between study inclusion and delivery of temporary prosthesis) - Cumulative analgesic consumption score (CACS) - Phantom pain occurence;Timepoint(s) of evaluation of this end point: - CACS: at baseline (J-7 before placement of the patch), one day and six weeks after patch placement - Phantom pain occurence: 6 months after patch placement | — |
Countries
Belgium
Contacts
Public ContactSamar Hatem
CHU Brugmann
Outcome results
None listed