Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2026-03-17 @ 10:00 AM
Study NCT ID:
NCT01748435
Status:
UNKNOWN
Last Update Posted:
2012-12-12
First Post:
2012-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pre-emptive Analgesia With Qutenza in Lower Limb Amputation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-04-09', 'releaseDate': '2019-01-08'}], 'estimatedResultsFirstSubmitDate': '2019-01-08'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009437', 'term': 'Neuralgia'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002211', 'term': 'Capsaicin'}], 'ancestors': [{'id': 'D053284', 'term': 'Polyunsaturated Alkamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005229', 'term': 'Fatty Acids, Monounsaturated'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2014-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-12-10', 'studyFirstSubmitDate': '2012-12-10', 'studyFirstSubmitQcDate': '2012-12-10', 'lastUpdatePostDateStruct': {'date': '2012-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Chronic neuropathic pain', 'timeFrame': '12 weeks', 'description': 'Chronic neuropathic pain as assessed by Visual Analogue Pain Score'}], 'secondaryOutcomes': [{'measure': 'Neuropathic pain', 'timeFrame': '1 weeks, 6 weeks, 12 weeks', 'description': 'Assessed using VAS and Brief Pain Inventory'}, {'measure': 'Acute post-operative pain', 'timeFrame': 'Day 1, 3, 7', 'description': 'Assessed by Visual Analogue Pain Score'}, {'measure': 'Wound healing', 'timeFrame': '1 week', 'description': 'Assessed using standardised, validated wound healing tools'}, {'measure': 'Quality of life', 'timeFrame': '12 weeks', 'description': 'Assessed by EQ-5D'}, {'measure': 'Safety and tolerability', 'timeFrame': '1 day, 12 weeks', 'description': 'Skin will be assessed for breaks/ blisters and tolerability including the need for rescue analgesia will be recorded'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Neuropathic pain', 'Lower limb amputation', 'Pre-emptive analgesia'], 'conditions': ['Neuropathic Pain', 'Lower Limb Amputation']}, 'descriptionModule': {'briefSummary': 'Neuropathic (nerve pain) following amputation of a limb is very common, affecting 60-80% of patients (Sherman et al, 1984). It can prolong their recovery making it difficult to fit protheses and mobilise. Current treatment options are limited and existing painkillers have significant side effects. Nevertheless there is some evidence that pre-emptive analgesia (pain relief provided prior to the surgery) has additional benefits after the surgery (Ypsilantis \\& Tang, 2010) Qutenza (topical capsaicin 8%)is a novel analgesic agent which is applied directly onto the skin. It works by desensitising to pain receptors in the skin (Nolano et al., 1999) and has been shown to be effective in reducing neuropathic pain in other conditions (Backonja et al., 2008) We propose to evaluate the use of Qutenza for pre-emptive analgesia in patients undergoing amputation of a limb. This is a small, pilot, randomised controlled study of 30 patients undergoing lower limb amputation who will have Qutenza or active control applied prior to surgery. They will be followed up for 12 weeks post-operatively with regular assessment of pain scores, quality of life and wound healing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients undergoing lower limb amputation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All adult patients \\>18 years old undergoing lower limb amputation\n\nExclusion Criteria:\n\nTraumatic amputation Severe active sepsis in non-viable limb Illness necessitating urgent surgery \\<24 hours after admission to hospital Hypersensitivity to Qutenza, Emla or any of the excipients Broken skin or active ulceration at the site of application Severe uncontrolled hypertension (systolic BP \\>200) Proven cardiac event during the preceding 3 months Women who are pregnant or breast feeding Lack of capacity or inability to provide informed consent Declines participation in the study'}, 'identificationModule': {'nctId': 'NCT01748435', 'briefTitle': 'Pre-emptive Analgesia With Qutenza in Lower Limb Amputation', 'organization': {'class': 'OTHER', 'fullName': 'NHS Greater Glasgow and Clyde'}, 'officialTitle': 'The Role of Pre-emptive Analgesia With Qutenza (Topical Capsaicin 8%) in Preventing Neuropathic Pain Following Lower Limb Amputation: a Pilot Randomised Controlled Study', 'orgStudyIdInfo': {'id': 'GU11SU387'}, 'secondaryIdInfos': [{'id': '2012-001587-30', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Qutenza', 'description': 'Single treatment with QUTENZA (topical capsaicin 8%) transdermal patch', 'interventionNames': ['Drug: Qutenza']}], 'interventions': [{'name': 'Qutenza', 'type': 'DRUG', 'otherNames': ['Qutenza (topical capsaicin 8%)'], 'description': 'Single treatment with Qutenza', 'armGroupLabels': ['Qutenza']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G116NY', 'city': 'Glasgow', 'state': 'Lanarkshire', 'country': 'United Kingdom', 'contacts': [{'name': 'Emma L Aitken, MBChB', 'role': 'CONTACT', 'email': 'EmmaAitken@nhs.net', 'phone': '01412111750'}, {'name': 'David B Kingsmore, MBChB MD', 'role': 'CONTACT', 'email': 'david.kingsmore@ggc.scot.nhs.uk', 'phone': '01412111750'}, {'name': 'Emma L Aitken, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Western Infirmary', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}], 'centralContacts': [{'name': 'Emma L Aitken, MBChB', 'role': 'CONTACT', 'email': 'EmmaAitken@nhs.net', 'phone': '01412111750'}, {'name': 'David B Kingsmore, MBChB MD', 'role': 'CONTACT', 'email': 'david.kingsmore@ggc.scot.nhs.uk', 'phone': '01412111750'}], 'overallOfficials': [{'name': 'Emma L Aitken, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NHS Greater Glasgow and Clyde'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NHS Greater Glasgow and Clyde', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Resrach Fellow', 'investigatorFullName': 'Emma Aitken', 'investigatorAffiliation': 'NHS Greater Glasgow and Clyde'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-01-08', 'type': 'RELEASE'}, {'date': '2019-04-09', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Emma Aitken, Clinical Resrach Fellow, NHS Greater Glasgow and Clyde'}}}}