Clinical trial NCT02696720: A Trial of Lidocaine Patch for Lower Limb Amputation Pain
Official title: A Randomized Controlled Trial of Lidocaine Patch for Lower Limb Amputation Pain
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Phantom Limb Pain (PLP)
Primary/Secondary Scar Hyperalgesia
Keywords: lidocaine
phantom limb pain (PLP)
Primary/secondary scar hyperalgesia
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2016-03-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phantom limb pain (PLP) and scar hyperalgesia (SH) are frequent problems after amputation; in particular most persons who undergo limb amputation will experience phantom pain. The neuropathic nature of PLP suggests the involvement of both peripheral and central neurological mechanisms, including neuroplastic changes in the central nervous system. PLP as other central nervous system-related pain syndromes remains a challenge for treatment. Scar hyperalgesia involves peripheral mechanisms and results frim the production of substances liberated by damaged skin cells. These inflammatory substances lower the pain threshold by altering the chemical environment of skin nerve endings. Scan hyperalgesia is associated with secondary mechanical hyperalgesia in the skin area around the scar.

The lidocaine patch 5% is a topical analgesic acting by blocking sodium channels of peripheral nerve endings and by inhibiting ectopic discharges in sensitized and hyperactive cutaneous nociceptors. The patch is noninvasive, with minimal systemic absorption resulting in a reduced risk of drug-drug interaction. In addition, a central analgesic effect of lidocaine has been suggested. The lidocaine patch 5% is currently licensed for the treatment of symptomatic postherpetic neuralgia. It also has been successfully used in patients with other neuropathic pain states, such as entrapment neuropathies, painful idiopathic distal sensory polyneuropathies and postoperative/post traumatic neuropathic chronic cutaneous pain. The lidocaine patch has not been studied for the management and prevention of phantom limb pain.

The aim of the present research 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 likelihood of developing persistent phantom limb pain.

This study is designed as a randomized controlled multicentric double blind trial, in which the effectiveness of applying a 5% lidocaine patch for 6 weeks will be compared with a sham.


Eligibility criteria: Inclusion Criteria:

* All above or below knee amputations , two months or more after surgery, after complete wound healing (no clips, no stitches, no seepage)

Exclusion Criteria:

* History of central nervous system disease
* History of major psychiatric disease (MMS\<23/30, HADS\>8/21)
* Pregnancy
* Known hypersensitivity to local anesthetics (lidocaine, bupivacaine, etidocaine, mepivacaine, prilocaine)
* skin irritation on the stump

Primary outcomes:
measure: Patient-reported overall daily pain intensity
timeFrame: Daily, starting seven days before patch placement (baseline) till six weeks after patch placement
Secondary outcomes:
measure: Neuropathic Pain (DN4)
timeFrame: at baseline - 7 days before patch placement
measure: Neuropathic pain
timeFrame: at baseline - 7 days before patch placement
measure: Neuropathic pain
timeFrame: One day after patch placement
measure: Neuropathic pain
timeFrame: 6 weeks after patch placement
measure: Neuropathic pain
timeFrame: 6 months after patch placement
measure: Pain (McGill)
timeFrame: at baseline - 7 days before patch placement
measure: Pain (McGill)
timeFrame: One day after patch placement
measure: Pain (McGill)
timeFrame: 6 weeks after patch placement
measure: Quality of life
timeFrame: at baseline -7 days before patch placement
measure: Quality of life
timeFrame: six weeks after patch placement
measure: Quality of life
timeFrame: six months after patch placement
measure: Sleep quality
timeFrame: baseline -7 days before patch placement
measure: Sleep quality
timeFrame: 6 weeks after patch placement
measure: Sleep quality
timeFrame: 6 months after patch placement
measure: Delay of dress of provisory prosthesis
timeFrame: From the day of the surgery till the day of the delivery of temporary prosthesis, for a maximum of 6 months
measure: Delay of dress of provisory prosthesis
timeFrame: From the day of patient inclusion in the research protocol till the day of the delivery of temporary prosthesis, for a maximum of 6 months
measure: Cumulative analgesic consumption (morphine equivalents)
timeFrame: baseline -7 days before patch placement
measure: Cumulative analgesic consumption (morphine equivalents)
timeFrame: 1 day after patch placement
measure: Cumulative analgesic consumption (morphine equivalents)
timeFrame: 6 weeks after patch placement
measure: Phantom Limb Pain occurence
timeFrame: 6 months after patch placement
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann - Queen Astrid
city: Brussels
country: Belgium
facility: Erasme -CTR
Study officials:
affiliation: CHU Brugmann
name: Samar Hatem, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Brugmann
name: Simone Brienza, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasme
name: Valérie Gangji, MD
role: PRINCIPAL_INVESTIGATOR
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