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A Trial of Lidocaine Patch for Lower Limb Amputation Pain

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ClinicalTrials.gov Identifier: NCT02696720
Recruitment Status : Withdrawn (Lack of recruitment)
First Posted : March 2, 2016
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Samar Hatem, Brugmann University Hospital

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.


Condition or disease Intervention/treatment Phase
Phantom Limb Pain (PLP) Primary/Secondary Scar Hyperalgesia Drug: Lidocaine Other: Sham Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Lidocaine Patch for Lower Limb Amputation Pain
Actual Study Start Date : May 13, 2016
Actual Primary Completion Date : June 13, 2017
Actual Study Completion Date : June 13, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arm Intervention/treatment
Experimental: 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.
Drug: Lidocaine
Sham Comparator: 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.
Other: Sham



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Neuropathic Pain (DN4) [ Time Frame: at baseline - 7 days before patch placement ]
    Screening for neuropathic pain, by using the DN4 questionnaire

  2. Neuropathic pain [ Time Frame: at baseline - 7 days before patch placement ]
    Rated with the Neuropathic Pain Symptom Inventory

  3. Neuropathic pain [ Time Frame: One day after patch placement ]
    Rated with the Neuropathic Pain Symptom Inventory

  4. Neuropathic pain [ Time Frame: 6 weeks after patch placement ]
    Rated with the Neuropathic Pain Symptom Inventory

  5. Neuropathic pain [ Time Frame: 6 months after patch placement ]
    Rated with the Neuropathic Pain Symptom Inventory

  6. Pain (McGill) [ Time Frame: at baseline - 7 days before patch placement ]
    Rated by the Short-Form McGill Pain Questionnaire, sensitive to the effects of pain treatment.

  7. Pain (McGill) [ Time Frame: One day after patch placement ]
    Rated by the Short-Form McGill Pain Questionnaire, sensitive to the effects of pain treatment.

  8. Pain (McGill) [ Time Frame: 6 weeks after patch placement ]
    Rated by the Short-Form McGill Pain Questionnaire, sensitive to the effects of pain treatment.

  9. Quality of life [ Time Frame: at baseline -7 days before patch placement ]
    Rated by the SF36 questionnaire

  10. Quality of life [ Time Frame: six weeks after patch placement ]
    Will be rated by the SF36 questionnaire

  11. Quality of life [ Time Frame: six months after patch placement ]
    Will be rated by the SF36 questionnaire

  12. Sleep quality [ Time Frame: baseline -7 days before patch placement ]
    will be assessed with the Pittsburgh Sleep Quality index

  13. Sleep quality [ Time Frame: 6 weeks after patch placement ]
    will be assessed with the Pittsburgh Sleep Quality index

  14. Sleep quality [ Time Frame: 6 months after patch placement ]
    will be assessed with the Pittsburgh Sleep Quality index

  15. Delay of dress of provisory prosthesis [ Time Frame: From the day of the surgery till the day of the delivery of temporary prosthesis, for a maximum of 6 months ]
    Number of days between surgery and delivery of temporary prosthesis

  16. Delay of dress of provisory prosthesis [ Time Frame: 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 ]
    Number of days between inclusion in the research protocol and delivery of temporary prosthesis

  17. Cumulative analgesic consumption (morphine equivalents) [ Time Frame: baseline -7 days before patch placement ]
    Rated by the cumulative analgesic consumption score (CACS)

  18. Cumulative analgesic consumption (morphine equivalents) [ Time Frame: 1 day after patch placement ]
    Rated by the cumulative analgesic consumption score (CACS)

  19. Cumulative analgesic consumption (morphine equivalents) [ Time Frame: 6 weeks after patch placement ]
    Rated by the cumulative analgesic consumption score (CACS)

  20. Phantom Limb Pain occurence [ Time Frame: 6 months after patch placement ]
    occurence of phantom limb pain



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02696720


Locations
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Belgium
CHU Brugmann - Queen Astrid
Brussels, Belgium
Erasme -CTR
Brussels, Belgium
Sponsors and Collaborators
Brugmann University Hospital
Investigators
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Principal Investigator: Samar Hatem, MD CHU Brugmann
Principal Investigator: Simone Brienza, MD CHU Brugmann
Principal Investigator: Valérie Gangji, MD Erasme

Publications:

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Responsible Party: Samar Hatem, Head of clinic, Brugmann University Hospital
ClinicalTrials.gov Identifier: NCT02696720     History of Changes
Other Study ID Numbers: CHUB-patch lidocaine
First Posted: March 2, 2016    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Samar Hatem, Brugmann University Hospital:
lidocaine
phantom limb pain (PLP)
Primary/secondary scar hyperalgesia

Additional relevant MeSH terms:
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Hyperalgesia
Phantom Limb
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Perceptual Disorders
Neurobehavioral Manifestations
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action