Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2025-12-26 @ 2:15 AM
Study NCT ID:
NCT04314505
Status:
UNKNOWN
Last Update Posted:
2020-07-21
First Post:
2020-03-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Opioid-Sparing Protocol Comparing With Opioid-based Protocol After Bilateral 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-08-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-19', 'studyFirstSubmitDate': '2020-03-12', 'studyFirstSubmitQcDate': '2020-03-17', 'lastUpdatePostDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain scores using numerical rating scale (VAS, 0 to 10) at rest', 'timeFrame': 'Post-operative 6 hours after surgery', 'description': 'Post-operative 6 hours'}, {'measure': 'Pain scores using numerical rating scale (VAS, 0 to 10) at rest', 'timeFrame': 'Post-operative 12 hours after surgery', 'description': 'Post-operative 12 hours'}, {'measure': 'Pain scores using numerical rating scale (VAS, 0 to 10) at rest', 'timeFrame': 'Post-operative 24 hours after surgery', 'description': 'Post-operative 24 hours'}, {'measure': 'Pain scores using numerical rating scale (VAS, 0 to 10) at rest', 'timeFrame': 'Post-operative 48 hours after surgery', 'description': 'Post-operative 48 hours'}, {'measure': 'Pain scores using numerical rating scale (VAS, 0 to 10) at rest', 'timeFrame': 'Post-operative 72 hours after surgery', 'description': 'Post-operative 72 hours'}, {'measure': 'Pain scores using numerical rating scale (VAS, 0 to 10) at motion', 'timeFrame': 'Post-operative 24 hours after surgery', 'description': 'Post-operative 24 hours'}, {'measure': 'Pain scores using numerical rating scale (VAS, 0 to 10) at motion', 'timeFrame': 'Post-operative 48 hour hours after surgery', 'description': 'Post-operative 48 hours'}, {'measure': 'Pain scores using numerical rating scale (VAS, 0 to 10) at motion', 'timeFrame': 'Post-operative 72 hour hours after surgery', 'description': 'Post-operative 72 hours'}], 'secondaryOutcomes': [{'measure': 'maximum angle of continuous passive motion (CPM) as tolerated (Degrees)', 'timeFrame': '0-72 hours after surgery', 'description': 'recorded at post-operative 24 hours, 48 hours and 72 hours'}, {'measure': 'Cumulative morphine consumption(mg)', 'timeFrame': '0-72 hours after surgery', 'description': 'recorded at post-operative 24 hours, 48 hours and 72 hours'}, {'measure': 'drug-related (opioid) adverse events', 'timeFrame': '0-72 hours after surgery', 'description': 'nausea/vomiting, dizziness, urinary retention, pruritus, dry mouth, constipation, dyspepsia, GI bleeding, pitting edema over lower extremities, cardiovascular event, respiratory depression, delirium or coma'}, {'measure': 'Satisfaction scale (0-100 points)', 'timeFrame': 'postoperative 2 weeks after surgery', 'description': 'satisfaction with regard to the efficacy and safety of the pain management protocol.'}, {'measure': 'Length of hospital stay (LOS) (Days)', 'timeFrame': 'After surgery until discharge (about 3-5 days after surgery)', 'description': 'Time from admission to discharge'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bilateral Total Knee Arthroplasty', 'Opioid Use', 'Opioid Sparing', 'Postoperative pain'], 'conditions': ['Knee Replacement', 'Postoperative Pain', 'Opioid Use']}, 'descriptionModule': {'briefSummary': 'The concern for the opioid use in the total knee arthroplasty continues to rise in recent decades. Historically, the total knee arthroplasty consumed high doses opioids in the postoperative periods. Compared to the Opioid-Based patient controlled analgesia(PCA), the opioid-sparing protocol may have benefits to decrease the concerns of the opioid use and opioid-related complication and provides the equivalent efficacy for pain control. The purpose of this trial in to provide a novel opioid-sparing protocol (OSP) to evaluate the efficacy for pain control and reducing the immediate postoperative opioid consumption.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient with bilateral advanced knee osteoarthritis undergoing simultaneous bilateral total knee arthroplasty surgery\n* willing to participate in this study and randomly allocated to either opioid-sparing protocol or PCA protocol.\n\nExclusion Criteria:\n\n* patient who refused to participate or with contraindication or hypersensitivity to any of the study drugs\n* chronic pain disorder (exceeding 50 mg oral morphine equivalence per day at time of recruitment)\n* substance abuse (e.g. alcoholism)\n* severe renal impairment.'}, 'identificationModule': {'nctId': 'NCT04314505', 'briefTitle': 'Opioid-Sparing Protocol Comparing With Opioid-based Protocol After Bilateral Total Knee Arthroplasty', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Taipei Veterans General Hospital, Taiwan'}, 'officialTitle': 'Opioid-Sparing Protocol Using for Postoperative Pain Management Comparing With Opioid-based Patient Control Analgesia After Simultaneous Bilateral Total Knee Arthroplasty: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2020-02-008C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Opioid Sparing Protocol', 'description': 'Preemptive(before incision): Parecoxib sodium 40 mg Postoperative: Parecoxib sodium 40 mg was given intravenously every 12 hours for 4 more doses.', 'interventionNames': ['Drug: Opioid-Sparing Protocol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Opioid Based Patient Controlled Analgesia', 'description': 'Preemptive(before incision) and Postoperative: the initial setting was 0.01mg/kg\\*hour, patient-controlled dose 2 mg, lock-out 5 minutes and limited 40mg in each 4 hours; adjusted by the PCA staff', 'interventionNames': ['Drug: Opioid-Based Patient Controlled Analgesia']}], 'interventions': [{'name': 'Opioid-Sparing Protocol', 'type': 'DRUG', 'otherNames': ['OSP Protocol'], 'description': 'After a general anesthesia procedure was performed, an experienced anesthesiologist performed ultrasound guided adductor canal block procedures on both knees. In the opioid-sparing group, a dose of Parecoxib sodium 40 mg was administrated through intravenous route before the incision. After the surgery, Parecoxib sodium 40 mg was given intravenously every 12 hours for 4 more doses. Before the wound closure, the periarticular injection (each side 10 ml of 0.25% Bupivacaine) was done. The total dosage would be recorded in the device. All patients received oral paracetamol 500mg, 4 times a day and oral celecoxib 200mg, 2 times a day after surgery.', 'armGroupLabels': ['Opioid Sparing Protocol']}, {'name': 'Opioid-Based Patient Controlled Analgesia', 'type': 'DRUG', 'otherNames': ['PCA Protocol'], 'description': 'After a general anesthesia procedure was performed, an experienced anesthesiologist performed ultrasound guided adductor canal block procedures on both knees. The patient was informed that the intravenous bolus of rescue morphine (4mg) was available every 4 hours if the pain was intolerable. In the PCA group, the device was applied before incision and the initial setting was 0.01mg/kg\\*hour, patient-controlled dose 2 mg, lock-out 5 minutes and limited 40mg in each 4 hours. After the surgery, the staff of PCA group would visit the patients and adjusted the dosage. The PCA was removed after 72 hours from the surgery. Before the wound closure, the periarticular injection (each side 10 ml of 0.25% Bupivacaine) was done. The total dosage would be recorded in the device. All patients received oral paracetamol 500mg, 4 times a day and oral celecoxib 200mg, 2 times a day after surgery.', 'armGroupLabels': ['Opioid Based Patient Controlled Analgesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '112', 'city': 'Taipei City', 'state': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Shang-Wen Tsai, Dr.', 'role': 'CONTACT', 'email': 'swtsai.vghtpe@gmail.com', 'phone': '+886-2-28717557'}], 'facility': 'Dep. of Orthopedics and Traumatology, Taipei Veterans General Hospital'}], 'centralContacts': [{'name': 'Hsuan-Hsiao Ma, M.D.', 'role': 'CONTACT', 'email': 'tyc20192@gmail.com', 'phone': '02-28717557'}], 'overallOfficials': [{'name': 'Shang-Wen Tsai, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Orthopaedic and Traumatology, Taipei Veterans General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Veterans General Hospital, Taiwan', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}