A Randomized Controlled Trial of Lidocaine Patch for Lower Limb Amputation Pain
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- Brugmann University Hospital
- Locations
- 2
- Primary Endpoint
- Patient-reported overall daily pain intensity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Lidocaine
During a period of six weeks, a lidocaine patch will be applied around the wound (cut in two parts, 1cm above and below the wound, without direct contact with the scar) for a total of twelve hours per day, during night time.
Intervention: Lidocaine (Drug)
Sham
During a period of six weeks, a visually identical patch (sham) will be applied around the wound (cut in two parts, 1cm above and below the wound, without direct contact with the scar) for a total of twelve hours per day, during night time.
Intervention: Sham (Other)
Outcomes
Primary Outcomes
Patient-reported overall daily pain intensity
Time Frame: Daily, starting seven days before patch placement (baseline) till six weeks after patch placement
The overall daily pain intensity (stump, scar and phantom pain combined) will be rated on a 0 to 100 visual analogue scale with anchors of 0 (no pain) to 100 (worst pain ever experienced).
Secondary Outcomes
- Phantom Limb Pain occurence(6 months after patch placement)
- Neuropathic Pain (DN4)(at baseline - 7 days before patch placement)
- Neuropathic pain(6 months after patch placement)
- Quality of life(six months after patch placement)
- Sleep quality(6 months after patch placement)
- Cumulative analgesic consumption (morphine equivalents)(6 weeks after patch placement)
- Pain (McGill)(6 weeks after patch placement)
- Delay of dress of provisory prosthesis(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)
Investigators
Samar Hatem
Head of clinic
Brugmann University Hospital