Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-28 @ 3:10 AM
Study NCT ID:
NCT04448457
Status:
COMPLETED
Last Update Posted:
2020-06-25
First Post:
2020-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sufentanil Sublingual Tablet System for Postoperative Pain Management After Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017409', 'term': 'Sufentanil'}, {'id': 'D010098', 'term': 'Oxycodone'}], 'ancestors': [{'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003061', 'term': 'Codeine'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-24', 'studyFirstSubmitDate': '2020-06-24', 'studyFirstSubmitQcDate': '2020-06-24', 'lastUpdatePostDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence of nausea and vomiting', 'timeFrame': 'At completion of the study period of 48 hours', 'description': 'Percentage of patients who experienced nausea or vomiting during the study period'}], 'primaryOutcomes': [{'measure': 'Postoperative pain score assessed at 24 hours', 'timeFrame': '24 hours after surgery', 'description': 'A numerical pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 \\[100-mm scale\\]) will be used to evaluate pain at rest and dynamically 24 hours after surgery'}], 'secondaryOutcomes': [{'measure': 'Postoperative pain scores assessed over 48 hours', 'timeFrame': '2 hours, 6 hours, 12 hours, 18 hours, 24 hours, 30 hours, 36 hours, 42 hours, 48 hours after surgery', 'description': 'A numerical pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 \\[100-mm scale\\]) will be used to evaluate pain at rest and dynamically'}, {'measure': 'Time to first mobilization', 'timeFrame': '2 hours, 6 hours, 12 hours, 18 hours, 24 hours, 30 hours, 36 hours, 42 hours, 48 hours after surgery', 'description': 'Successful mobilization with or without aid assessed at specific timepoints'}, {'measure': 'Patient satisfaction', 'timeFrame': 'At completion of the study period of 48 hours', 'description': 'Satisfaction for the method of pain control assessed using Patient Global Assessment (PGA) of the method of pain control questionnaire at the completion of the 48h study period which consist on a 4-point categorical scale, where 1 = poor, 2 = fair, 3 = good, and 4 = excellent.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SSTS', 'Oxycodone', 'Enhanced recovery after surgery'], 'conditions': ['Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '33216238', 'type': 'DERIVED', 'citation': 'Noel E, Miglionico L, Leclercq M, Jennart H, Fils JF, Van Rompaey N. Sufentanil sublingual tablet system versus oral oxycodone for management of postoperative pain in enhanced recovery after surgery pathway for total knee arthroplasty: a randomized controlled study. J Exp Orthop. 2020 Nov 20;7(1):92. doi: 10.1186/s40634-020-00306-x.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the effectiveness of Sublingual Sufentanil Tablets System (SSTS, Zalviso ®) to control postoperative pain after total knee arthroplasty in the context of early rehabilitation program.\n\nSSTS is a novel patient controlled analgesia system wich does not require intravenous access, potentially improving pain control and promoting mobilization.\n\nSSTS will be randomly compared to nurse-driven oral Oxycodone.', 'detailedDescription': 'Even with multimodal analgesia (combining local anesthetic infiltration, corticosteroids, non-steroidal anti-inflammatory drugs and acetaminophen), total knee arthroplasty is associated with acute moderate-to-severe postoperative pain requiring opioids treatment. We compare the efficacy of SSTS and oral Oxycodone in this context.\n\nAfter written informed consent, patients will be randomly assigned postoperatively to SSTS or Oral oxycodone group at a ratio 1:1. Pain scores, mobilization and patient satisfaction will be analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (age ≥ 18 years)\n* Scheduled for unilateral total knee arthroplasty under spinal anesthesia\n* American Society of Anesthesiologists (ASA) class 1-3\n\nExclusion Criteria:\n\n* Contraindication to medication used in our multimodal analgesia protocol (solumedrol, celecoxib, acetaminophen, ropivacaine)\n* Allergy to study medications\n* History of addiction or preoperative chronic use of opioids\n* Unicompartmental or revision knee replacement'}, 'identificationModule': {'nctId': 'NCT04448457', 'briefTitle': 'Sufentanil Sublingual Tablet System for Postoperative Pain Management After Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Tivoli'}, 'officialTitle': 'Sufentanil Sublingual Tablet System For Management Of Postoperative Pain In Enhanced Recovery After Surgery Pathway For Total Knee Arthroplasty: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'P2017/348'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SSTS group', 'description': 'Patients received sufentanil nanotab patient controlled analgesia (PCA) system (Zalviso) 15 mcg with 20 min of lockout interval during 48 hours postoperatively', 'interventionNames': ['Drug: Sufentanil Sublingual Tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oxycodone group', 'description': 'Patients received oxycodone extended-release tablet (OxyContin) 10 mg every 12 hours systematically plus Oxycodone 5 mg every 6 hours if numeric rating scale is above 3 during the 48 hours postoperatively', 'interventionNames': ['Drug: Oxycodone oral tablet and oxycodone extended-release oral tablet']}], 'interventions': [{'name': 'Sufentanil Sublingual Tablet', 'type': 'DRUG', 'otherNames': ['Zalviso'], 'description': '15 mcg with lockout interval of 20 min', 'armGroupLabels': ['SSTS group']}, {'name': 'Oxycodone oral tablet and oxycodone extended-release oral tablet', 'type': 'DRUG', 'otherNames': ['OxyNorm', 'OxyContin'], 'description': 'Oxycodone hydrochloride 5 mg and Oxycodone extended-release 10 mg', 'armGroupLabels': ['Oxycodone group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7100', 'city': 'La Louvière', 'country': 'Belgium', 'facility': 'Chu Tivoli', 'geoPoint': {'lat': 50.48657, 'lon': 4.18785}}], 'overallOfficials': [{'name': 'Emmanuel Noel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Tivoli'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Tivoli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}