Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-02-27 @ 4:07 PM
Study NCT ID:
NCT02696720
Status:
WITHDRAWN
Last Update Posted:
2018-01-23
First Post:
2016-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of Lidocaine Patch for Lower Limb Amputation Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010591', 'term': 'Phantom Limb'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'C005703', 'term': 'salicylhydroxamic acid'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Lack of recruitment', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-06-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-18', 'studyFirstSubmitDate': '2016-02-26', 'studyFirstSubmitQcDate': '2016-03-01', 'lastUpdatePostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient-reported overall daily pain intensity', 'timeFrame': 'Daily, starting seven days before patch placement (baseline) till six weeks after patch placement', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Neuropathic Pain (DN4)', 'timeFrame': 'at baseline - 7 days before patch placement', 'description': 'Screening for neuropathic pain, by using the DN4 questionnaire'}, {'measure': 'Neuropathic pain', 'timeFrame': 'at baseline - 7 days before patch placement', 'description': 'Rated with the Neuropathic Pain Symptom Inventory'}, {'measure': 'Neuropathic pain', 'timeFrame': 'One day after patch placement', 'description': 'Rated with the Neuropathic Pain Symptom Inventory'}, {'measure': 'Neuropathic pain', 'timeFrame': '6 weeks after patch placement', 'description': 'Rated with the Neuropathic Pain Symptom Inventory'}, {'measure': 'Neuropathic pain', 'timeFrame': '6 months after patch placement', 'description': 'Rated with the Neuropathic Pain Symptom Inventory'}, {'measure': 'Pain (McGill)', 'timeFrame': 'at baseline - 7 days before patch placement', 'description': 'Rated by the Short-Form McGill Pain Questionnaire, sensitive to the effects of pain treatment.'}, {'measure': 'Pain (McGill)', 'timeFrame': 'One day after patch placement', 'description': 'Rated by the Short-Form McGill Pain Questionnaire, sensitive to the effects of pain treatment.'}, {'measure': 'Pain (McGill)', 'timeFrame': '6 weeks after patch placement', 'description': 'Rated by the Short-Form McGill Pain Questionnaire, sensitive to the effects of pain treatment.'}, {'measure': 'Quality of life', 'timeFrame': 'at baseline -7 days before patch placement', 'description': 'Rated by the SF36 questionnaire'}, {'measure': 'Quality of life', 'timeFrame': 'six weeks after patch placement', 'description': 'Will be rated by the SF36 questionnaire'}, {'measure': 'Quality of life', 'timeFrame': 'six months after patch placement', 'description': 'Will be rated by the SF36 questionnaire'}, {'measure': 'Sleep quality', 'timeFrame': 'baseline -7 days before patch placement', 'description': 'will be assessed with the Pittsburgh Sleep Quality index'}, {'measure': 'Sleep quality', 'timeFrame': '6 weeks after patch placement', 'description': 'will be assessed with the Pittsburgh Sleep Quality index'}, {'measure': 'Sleep quality', 'timeFrame': '6 months after patch placement', 'description': 'will be assessed with the Pittsburgh Sleep Quality index'}, {'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', 'description': 'Number of days between surgery and delivery of temporary prosthesis'}, {'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', 'description': 'Number of days between inclusion in the research protocol and delivery of temporary prosthesis'}, {'measure': 'Cumulative analgesic consumption (morphine equivalents)', 'timeFrame': 'baseline -7 days before patch placement', 'description': 'Rated by the cumulative analgesic consumption score (CACS)'}, {'measure': 'Cumulative analgesic consumption (morphine equivalents)', 'timeFrame': '1 day after patch placement', 'description': 'Rated by the cumulative analgesic consumption score (CACS)'}, {'measure': 'Cumulative analgesic consumption (morphine equivalents)', 'timeFrame': '6 weeks after patch placement', 'description': 'Rated by the cumulative analgesic consumption score (CACS)'}, {'measure': 'Phantom Limb Pain occurence', 'timeFrame': '6 months after patch placement', 'description': 'occurence of phantom limb pain'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lidocaine', 'phantom limb pain (PLP)', 'Primary/secondary scar hyperalgesia'], 'conditions': ['Phantom Limb Pain (PLP)', 'Primary/Secondary Scar Hyperalgesia']}, 'referencesModule': {'references': [{'pmid': '14970960', 'type': 'BACKGROUND', 'citation': 'Robinson LR, Czerniecki JM, Ehde DM, Edwards WT, Judish DA, Goldberg ML, Campbell KM, Smith DG, Jensen MP. Trial of amitriptyline for relief of pain in amputees: results of a randomized controlled study. Arch Phys Med Rehabil. 2004 Jan;85(1):1-6. doi: 10.1016/s0003-9993(03)00476-3.'}, {'pmid': '15399521', 'type': 'BACKGROUND', 'citation': 'HARDY JD, WOLFF HG, GOODELL H. Experimental evidence on the nature of cutaneous hyperalgesia. J Clin Invest. 1950 Jan;29(1):115-40. doi: 10.1172/JCI102227. No abstract available.'}, {'pmid': '12616661', 'type': 'BACKGROUND', 'citation': 'Gammaitoni AR, Alvarez NA, Galer BS. Safety and tolerability of the lidocaine patch 5%, a targeted peripheral analgesic: a review of the literature. J Clin Pharmacol. 2003 Feb;43(2):111-7. doi: 10.1177/0091270002239817.'}, {'pmid': '10692621', 'type': 'BACKGROUND', 'citation': 'Koppert W, Ostermeier N, Sittl R, Weidner C, Schmelz M. Low-dose lidocaine reduces secondary hyperalgesia by a central mode of action. Pain. 2000 Mar;85(1-2):217-24. doi: 10.1016/s0304-3959(99)00268-7.'}, {'pmid': '17406167', 'type': 'BACKGROUND', 'citation': 'Nalamachu S, Crockett RS, Gammaitoni AR, Gould EM. A comparison of the lidocaine patch 5% vs naproxen 500 mg twice daily for the relief of pain associated with carpal tunnel syndrome: a 6-week, randomized, parallel-group study. MedGenMed. 2006 Aug 9;8(3):33.'}, {'pmid': '16266359', 'type': 'BACKGROUND', 'citation': 'Herrmann DN, Barbano RL, Hart-Gouleau S, Pennella-Vaughan J, Dworkin RH. An open-label study of the lidocaine patch 5% in painful idiopathic sensory polyneuropathy. Pain Med. 2005 Sep-Oct;6(5):379-84. doi: 10.1111/j.1526-4637.2005.00058.x.'}, {'pmid': '19788351', 'type': 'BACKGROUND', 'citation': 'Hans G, Joukes E, Verhulst J, Vercauteren M. Management of neuropathic pain after surgical and non-surgical trauma with lidocaine 5% patches: study of 40 consecutive cases. Curr Med Res Opin. 2009 Nov;25(11):2737-43. doi: 10.1185/03007990903282297.'}, {'pmid': '15733628', 'type': 'BACKGROUND', 'citation': 'Bouhassira D, Attal N, Alchaar H, Boureau F, Brochet B, Bruxelle J, Cunin G, Fermanian J, Ginies P, Grun-Overdyking A, Jafari-Schluep H, Lanteri-Minet M, Laurent B, Mick G, Serrie A, Valade D, Vicaut E. Comparison of pain syndromes associated with nervous or somatic lesions and development of a new neuropathic pain diagnostic questionnaire (DN4). Pain. 2005 Mar;114(1-2):29-36. doi: 10.1016/j.pain.2004.12.010. Epub 2005 Jan 26.'}, {'pmid': '15030944', 'type': 'BACKGROUND', 'citation': 'Bouhassira D, Attal N, Fermanian J, Alchaar H, Gautron M, Masquelier E, Rostaing S, Lanteri-Minet M, Collin E, Grisart J, Boureau F. Development and validation of the Neuropathic Pain Symptom Inventory. Pain. 2004 Apr;108(3):248-257. doi: 10.1016/j.pain.2003.12.024.'}, {'pmid': '3670870', 'type': 'BACKGROUND', 'citation': 'Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-197. doi: 10.1016/0304-3959(87)91074-8.'}, {'pmid': '2748771', 'type': 'BACKGROUND', 'citation': 'Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nThe 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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All above or below knee amputations , two months or more after surgery, after complete wound healing (no clips, no stitches, no seepage)\n\nExclusion Criteria:\n\n* History of central nervous system disease\n* History of major psychiatric disease (MMS\\<23/30, HADS\\>8/21)\n* Pregnancy\n* Known hypersensitivity to local anesthetics (lidocaine, bupivacaine, etidocaine, mepivacaine, prilocaine)\n* skin irritation on the stump'}, 'identificationModule': {'nctId': 'NCT02696720', 'briefTitle': 'A Trial of Lidocaine Patch for Lower Limb Amputation Pain', 'organization': {'class': 'OTHER', 'fullName': 'Brugmann University Hospital'}, 'officialTitle': 'A Randomized Controlled Trial of Lidocaine Patch for Lower Limb Amputation Pain', 'orgStudyIdInfo': {'id': 'CHUB-patch lidocaine'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lidocaine', 'description': '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.', 'interventionNames': ['Drug: Lidocaine']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham', 'description': '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.', 'interventionNames': ['Other: Sham']}], 'interventions': [{'name': 'Lidocaine', 'type': 'DRUG', 'armGroupLabels': ['Lidocaine']}, {'name': 'Sham', 'type': 'OTHER', 'armGroupLabels': ['Sham']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brussels', 'country': 'Belgium', 'facility': 'CHU Brugmann - Queen Astrid', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Brussels', 'country': 'Belgium', 'facility': 'Erasme -CTR', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Samar Hatem, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Brugmann'}, {'name': 'Simone Brienza, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Brugmann'}, {'name': 'Valérie Gangji, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Erasme'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brugmann University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of clinic', 'investigatorFullName': 'Samar Hatem', 'investigatorAffiliation': 'Brugmann University Hospital'}}}}