Ignite Creation Date:
2025-12-24 @ 9:20 PM
Ignite Modification Date:
2025-12-30 @ 5:28 AM
Study NCT ID:
NCT00443404
Status:
COMPLETED
Last Update Posted:
2011-11-07
First Post:
2007-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimized Perioperative Analgesia Reduces the Prevalence and the Intensity of Phantom Pain in Lower Limb Amputation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010591', 'term': 'Phantom Limb'}, {'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D010146', 'term': 'Pain'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-04', 'studyFirstSubmitDate': '2007-03-05', 'studyFirstSubmitQcDate': '2007-03-05', 'lastUpdatePostDateStruct': {'date': '2011-11-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAS and McGill PRI(R)2 scores for phantom and stump pain are recorded 48 and 24 hours before, and 4 and 10 days, 1 and 6 months after amputation. Phantom and stump pain intensity are the endpoints of the study.', 'timeFrame': 'six months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['phantom', 'amputation', 'analgesia', 'pain', 'preemptive', 'perioperative', 'lower limb amputation', 'intensity of phantom limb pain', 'preemptive analgesia reduces phantom pain', 'perioperative analgesia reduces phantom pain', 'Severe Phantom Limb Pain (VAS>70 mm)', 'resistant to medical treatment one week before amputation'], 'conditions': ['Phantom Limb Pain']}, 'referencesModule': {'references': [{'pmid': '21368651', 'type': 'DERIVED', 'citation': 'Karanikolas M, Aretha D, Tsolakis I, Monantera G, Kiekkas P, Papadoulas S, Swarm RA, Filos KS. Optimized perioperative analgesia reduces chronic phantom limb pain intensity, prevalence, and frequency: a prospective, randomized, clinical trial. Anesthesiology. 2011 May;114(5):1144-54. doi: 10.1097/ALN.0b013e31820fc7d2.'}]}, 'descriptionModule': {'briefSummary': 'Severe pre-amputation pain is associated with phantom pain development, and phantom pain models assign major importance to central and peripheral nervous system changes related to pre-amputation pain. Several interventions have been evaluated for phantom pain prevention, including continuous brachial plexus blockade5, intravenous6 or epidural ketamine administration, postoperative perineural ketamine/clonidine infusion8 and oral gabapentin9, but their true effect remains unclear.', 'detailedDescription': 'In a prospective, randomized, double-blind trial, 65 patients undergoing elective lower limb amputation were assigned to one of five analgesic regimens. Patients in groups 1-4 had lumbar epidural catheter placed 48 hours before amputation, and received epidural bupivacaine/fentanyl or saline infusion before and/or after amputation. Patients receiving epidural saline also had IV Fentanyl Patient-Control Analgesia, whereas patients receiving epidural analgesia also had IV saline. Group 5 (control) received IM meperidine and oral codeine/acetaminophen. VAS and McGill Pain Questionnaire (MPQ) scores (for ischemic, phantom and stump pain) were recorded starting 48 hours before, continuing until 48 hours after amputation, and at 4 days, 10 days, 1 and 6 months after amputation. Phantom and stump pain intensity and frequency were the main study endpoints.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '82 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18, Visual Analog. Scale (VAS) pain score \\>70mm which was frequent or continuous one week before scheduled major (above or below knee) amputation, and patient consent.\n\nExclusion Criteria:\n\n* No written patient consent\n* Age \\< 18 years\n* Age \\> 82 years\n* Antiplatelet medication\n* Mental status not acceptable\n* Exclusion criteria were age \\>85\n* Emergency amputation\n* Ipsilateral re-amputation\n* Foot or toe amputation\n* Inability to complete a detailed pain questionnaire\n* History of chronic pain or substance abuse\n* Active psychiatric disease requiring treatment\n* Any contraindication to epidural catheter placement (anticoagulation, anti-platelet medications, previous lumbar spine surgery).'}, 'identificationModule': {'nctId': 'NCT00443404', 'briefTitle': 'Optimized Perioperative Analgesia Reduces the Prevalence and the Intensity of Phantom Pain in Lower Limb Amputation', 'organization': {'class': 'OTHER', 'fullName': 'University of Patras'}, 'officialTitle': 'Double Blind, Placebo Controlled Study for the Study of the Effectiveness of Perioperative Analgesia in Phantom and Stump Pain', 'orgStudyIdInfo': {'id': 'phantom pain-UPatras'}, 'secondaryIdInfos': [{'id': 'There are no secondary Id'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'perioperative epidural analgesia', 'interventionNames': ['Procedure: perioperative epidural catheter']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Iv PCA Fentanyl preoperative, Epidural analgesia postoperative', 'interventionNames': ['Procedure: perioperative epidural catheter']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'perioperative IV PCA Fentanyl, epidural anesthesia', 'interventionNames': ['Procedure: perioperative epidural catheter']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4', 'description': 'perioperative IV PCA Fentanyl general anesthesia', 'interventionNames': ['Procedure: perioperative epidural catheter']}, {'type': 'PLACEBO_COMPARATOR', 'label': '5', 'description': 'IV PCA with saline 0.9% and sc saline 0.9%in the L3-L4 area. IM meperidine, po codeine/acetaminophen, IV acetaminophen and IV parecoxib', 'interventionNames': ['Procedure: perioperative epidural catheter']}], 'interventions': [{'name': 'perioperative epidural catheter', 'type': 'PROCEDURE', 'description': 'Perioperative epidural catheter in groups 1-4. Pre- and postoperative epidural analgesia in group 1. Preoperative IV PCA Fentanyl and postoperative epidural analgesia in group 2. Perioperative IV PCA Fentanyl in groups 2,3. IM meperidine p.o. codeine/acetaminophen, IV acetaminophen and IV parecoxib in group 5 (control)', 'armGroupLabels': ['1', '2', '3', '4', '5']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Pátrai', 'country': 'Greece', 'geoPoint': {'lat': 38.2462, 'lon': 21.73508}}], 'overallOfficials': [{'name': 'Diamanto N. Aretha, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Patras, School of Medicine, University Hospital of Patras, Rion, 26500, Department of Anaesthesiology and Critical Care Medicine'}, {'name': 'Menelaos Karanikolas, MD, MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Patras, School of Medicine, University Hospital of Patras, Rion, 26500, Department of Anaesthesiology and Critical Care Medicine'}, {'name': 'Kriton S Filos, MD Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Patras, School of Medicine, University Hospital of Patras, Rion, 26500, Department of Anaesthesiology and Critical Care Medicine'}, {'name': 'Georgia Monantera, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Patras, School of Medicine, University Hospital of Patras, Rion, 26500, Department of Anaesthesiology and Critical Care Medicine'}, {'name': 'Ioannis Tsolakis, MD Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Patras, School of Medicine, University Hospital of Patras, Rion, 26500, Department of Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Patras', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Diamanto Aretha', 'oldOrganization': 'University Hospital of Patras'}}}}