Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2026-01-10 @ 10:30 AM
Study NCT ID:
NCT01126359
Status:
COMPLETED
Last Update Posted:
2014-05-29
First Post:
2010-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Lidocaine Analgesia For Removal Of Wound Vac Dressings
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], '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'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Erik.Kubiak@hsc.utah.edu', 'phone': '801-587-5404', 'title': 'Dr. Erik Kubiak', 'organization': 'Department of Orthopaedics'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Overall subjectivity of pain and dosing of narcotic medications, all male cohort, timing of wound VAC changes, did not define the ideal lidocaine dosing for VAC changes or dosing method.'}}, 'adverseEventsModule': {'timeFrame': '48 hours', 'eventGroups': [{'id': 'EG000', 'title': 'First Intervention (Lidocaine)', 'otherNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'First Intervention (Placebo)', 'otherNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Second Intervention (Placebo)', 'otherNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Second Intervention (Lidocaine)', 'otherNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Visual Analog Scale Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lidocaine', 'description': 'All patients who received lidocaine prior to VAC dressing change.'}, {'id': 'OG001', 'title': 'Placebo-Saline', 'description': 'All patients who received placebo-saline prior to VAC dressing change.'}, {'id': 'OG002', 'title': 'Lidocaine Minus Placebo-Saline Difference', 'description': 'Includes participants randomized to receive Lidocaine first, then Placebo-Saline; and vice versa. Visial Analog Pain Scores are determined at each pain measurement time point (during/after VAC dressing removal) as the Lidocaine minus Placebo-Saline VAS difference for each participant. A negative VAS difference indicates a reduction in the level of pain with Lidocaine compared to Placebo-Saline utilizing crossover intervention.'}], 'classes': [{'title': 'During VAC change', 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000', 'lowerLimit': '5.5', 'upperLimit': '7.4'}, {'value': '8.9', 'groupId': 'OG001', 'lowerLimit': '8.0', 'upperLimit': '9.7'}, {'value': '-2.4', 'groupId': 'OG002', 'lowerLimit': '-3.0', 'upperLimit': '-1.7'}]}]}, {'title': '5 min post-VAC change', 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000', 'lowerLimit': '3.2', 'upperLimit': '5.7'}, {'value': '6.4', 'groupId': 'OG001', 'lowerLimit': '5.3', 'upperLimit': '7.5'}, {'value': '-2.0', 'groupId': 'OG002', 'lowerLimit': '-3.3', 'upperLimit': '-0.8'}]}]}, {'title': '10 min post VAC change', 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '4.5'}, {'value': '4.7', 'groupId': 'OG001', 'lowerLimit': '3.6', 'upperLimit': '5.8'}, {'value': '-1.5', 'groupId': 'OG002', 'lowerLimit': '-2.8', 'upperLimit': '-0.1'}]}]}, {'title': '20 min post VAC change', 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '3.5'}, {'value': '4.2', 'groupId': 'OG001', 'lowerLimit': '3.2', 'upperLimit': '5.1'}, {'value': '-1.8', 'groupId': 'OG002', 'lowerLimit': '-3.0', 'upperLimit': '-0.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': '20 minutes', 'description': 'Visial Analog Pain Scores (VAS) range from 0 (no pain) - 10 (worst pain ever). Visial Analog Pain Scores are determined at each pain measurement time point (during/after VAC dressing removal).', 'unitOfMeasure': 'Visial Analog Pain Score (VAS)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Break-through Narcotic Requirement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lidocaine', 'description': 'All patients who received lidocaine prior to VAC dressing change.'}, {'id': 'OG001', 'title': 'Placebo-Saline', 'description': 'All patients who received placebo-saline prior to VAC dressing change.'}, {'id': 'OG002', 'title': 'Lidocaine Minus Placebo-Saline Difference', 'description': 'Includes participants randomized to receive Lidocaine first, then Placebo-Saline; and vice versa. Each patient narcotic requirements are determined at each measured time point (during/after VAC dressing removal) as the Lidocaine minus Placebo-Saline difference (mg). A negative narcotic requirement difference indicates a reduction in medication dosed (mg) used during and after VAC dressing change in a crossover intervention technique.'}], 'classes': [{'title': 'During VAC change', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '2.3'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '3.9'}, {'value': '-1.7', 'groupId': 'OG002', 'lowerLimit': '-2.3', 'upperLimit': '-1.1'}]}]}, {'title': '5 min post-VAC change', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.6'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '1.9'}, {'value': '-0.4', 'groupId': 'OG002', 'lowerLimit': '-1.0', 'upperLimit': '-0.2'}]}]}, {'title': '10 min post VAC change', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '-0.3', 'upperLimit': '0.6'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.8'}, {'value': '-0.2', 'groupId': 'OG002', 'lowerLimit': '-0.8', 'upperLimit': '0.4'}]}]}, {'title': '20 min post VAC change', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-0.4', 'upperLimit': '0.3'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.6'}, {'value': '-0.3', 'groupId': 'OG002', 'lowerLimit': '-0.7', 'upperLimit': '0.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': '20 minutes', 'description': 'Patient break-through narcotic requirements in morphine equivalents are 0.2 mg of dilaudid = 1 mg of morphine, iv., used during and after VAC dressing change.', 'unitOfMeasure': 'Narcotic Requirements (mg)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lidocaine Then Placebo-Saline', 'description': 'Interventional dressing change: iv or po pain medication with injection of 1% lidocaine retrograde up the suction tube into the sponge. Then, control dressing change: iv or po pain medication and injection of 1% saline retrograde up the suction tube.'}, {'id': 'FG001', 'title': 'Placebo-Saline Then Lidocaine', 'description': 'Control dressing change: iv or po pain medication and injection of 1% saline retrograde up the suction tube. Then, interventional dressing change: iv or po pain medication with injection of 1% lidocaine retrograde up the suction tube into the sponge.'}], 'periods': [{'title': 'First Intervention (20-minutes)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Dressing Replacement/Healing (48-hours)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention (20-minutes)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'Includes participants randomized to receive Lidocaine first, then Placebo-Saline; and vice versa.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38', 'spread': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-21', 'studyFirstSubmitDate': '2010-05-17', 'resultsFirstSubmitDate': '2013-01-22', 'studyFirstSubmitQcDate': '2010-05-18', 'lastUpdatePostDateStruct': {'date': '2014-05-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-05-21', 'studyFirstPostDateStruct': {'date': '2010-05-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale Pain Score', 'timeFrame': '20 minutes', 'description': 'Visial Analog Pain Scores (VAS) range from 0 (no pain) - 10 (worst pain ever). Visial Analog Pain Scores are determined at each pain measurement time point (during/after VAC dressing removal).'}], 'secondaryOutcomes': [{'measure': 'Break-through Narcotic Requirement', 'timeFrame': '20 minutes', 'description': 'Patient break-through narcotic requirements in morphine equivalents are 0.2 mg of dilaudid = 1 mg of morphine, iv., used during and after VAC dressing change.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Wound Vacuum Assisted Dressings', 'Lidocaine', 'Dressing change', 'Pain management', 'palliative care'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '12374481', 'type': 'BACKGROUND', 'citation': 'Webb LX. New techniques in wound management: vacuum-assisted wound closure. J Am Acad Orthop Surg. 2002 Sep-Oct;10(5):303-11. doi: 10.5435/00124635-200209000-00002.'}, {'pmid': '11839329', 'type': 'BACKGROUND', 'citation': 'Garner GB, Ware DN, Cocanour CS, Duke JH, McKinley BA, Kozar RA, Moore FA. Vacuum-assisted wound closure provides early fascial reapproximation in trauma patients with open abdomens. Am J Surg. 2001 Dec;182(6):630-8. doi: 10.1016/s0002-9610(01)00786-3.'}, {'pmid': '18279921', 'type': 'BACKGROUND', 'citation': 'Choe JH, Kwak KW, Hong JH, Lee HM. Efficacy of lidocaine spray as topical anesthesia for outpatient rigid cystoscopy in women: a prospective, randomized, double-blind trial. Urology. 2008 Apr;71(4):561-6. doi: 10.1016/j.urology.2007.11.057. Epub 2008 Feb 15.'}, {'pmid': '23343829', 'type': 'RESULT', 'citation': 'Christensen TJ, Thorum T, Kubiak EN. Lidocaine analgesia for removal of wound vacuum-assisted closure dressings: a randomized double-blinded placebo-controlled trial. J Orthop Trauma. 2013 Feb;27(2):107-12. doi: 10.1097/BOT.0b013e318251219c.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this prospective study is to compare pain levels and pain medication dose requirements in patients with topical negative pressure (TNP) dressings removed in a standard manner (i.v. or p.o. pain meds) compared to dressings removed with lidocaine analgesia, via injection retrograde up the suction tube into the foam prior to removal. Our null hypothesis is that there will be no difference in overall pain scores or medication requirements when patients receive a saline, control injection and pain medications, compared to when their dressings are changed with a lidocaine injection into the sponge, with pain medications. Our objective is to disprove this null hypothesis with statistical significance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. wounds to which a split-thickness autologous skin graft applied;\n2. infected wounds after debridement;\n3. open fracture wounds;\n4. acute soft-tissue wounds (with exposed tendon, bone, hardware, and/or joint);\n5. fasciotomy wounds after compartment syndrome;\n6. chronic non-healing wounds;\n7. surgical wounds that are difficult to close due to tension; or\n8. wounds with external fixation pins or tubes with irritation or drainage.\n\nExclusion Criteria:\n\n1. allergy to lidocaine;\n2. allergy to the polyurethane foam or impermeable seal;\n3. malignancy associated with the wound;\n4. extremity insensate to pain due to any cause (including diabetic neuropathy, or any neurologic disorder therein);\n5. pregnancy as diagnosed by urine pregnancy test.'}, 'identificationModule': {'nctId': 'NCT01126359', 'briefTitle': 'Lidocaine Analgesia For Removal Of Wound Vac Dressings', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Lidocaine Analgesia For Removal Of Wound Vacuum Assisted Closure Dressings: A Randomized Double Blinded Controlled Trial', 'orgStudyIdInfo': {'id': '29398'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Lidocaine then Placebo-Saline', 'interventionNames': ['Drug: Lidocaine', 'Drug: Placebo-Saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo-Saline then Lidocaine', 'interventionNames': ['Drug: Lidocaine', 'Drug: Placebo-Saline']}], 'interventions': [{'name': 'Lidocaine', 'type': 'DRUG', 'otherNames': ['xylocaine'], 'description': 'Interventional dressing change: iv or po pain medication with injection of 1% lidocaine retrograde up the suction tube into the sponge.', 'armGroupLabels': ['Lidocaine then Placebo-Saline', 'Placebo-Saline then Lidocaine']}, {'name': 'Placebo-Saline', 'type': 'DRUG', 'otherNames': ['0.9% normal saline'], 'description': 'Control dressing change: iv or po pain medication and injection of 0.9% normal saline retrograde up the suction tube.', 'armGroupLabels': ['Lidocaine then Placebo-Saline', 'Placebo-Saline then Lidocaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Erik N Kubiak, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Eric Kubiak', 'investigatorAffiliation': 'University of Utah'}}}}