Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-02-25 @ 8:19 PM
Study NCT ID:
NCT02272660
Status:
COMPLETED
Last Update Posted:
2015-08-28
First Post:
2014-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Parecoxib for Pain Management After Total Knee Arthroplasty and Total Hip 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': 'C409945', 'term': 'parecoxib'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-27', 'studyFirstSubmitDate': '2014-10-17', 'studyFirstSubmitQcDate': '2014-10-21', 'lastUpdatePostDateStruct': {'date': '2015-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Testing of body temperature,routine blood examination, IL-6 and IL-10', 'timeFrame': 'hospital admission and 1, 3, 6 days after the surgery'}], 'primaryOutcomes': [{'measure': 'To evaluate the Morphine consumption in each group patients', 'timeFrame': '4 hours to 6 days after the surgery'}], 'secondaryOutcomes': [{'measure': 'To evaluate Patient-Controlled Intravenous Analgesia (PCIA) duration', 'timeFrame': '4 hours to 6 days after the surgery'}, {'measure': 'To evaluate the Visual Analog Scale (VAS) in each group patients underwent total knee arthroplasty and total hip arthroplasty', 'timeFrame': '4 hours to 6 days after the surgery'}, {'measure': 'Function recovery of knee Range of Motion (ROM) for patients received surgery', 'timeFrame': '3 and 6 days after the surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['preemptive analgesia', 'parecoxib sodium', 'total knee arthroplasty', 'total hip arthroplasty'], 'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'Evaluated the effect of perioperative parecoxib administration on postoperative pain, analgesic use, function recovery, inflammatory response and bleeding risk.', 'detailedDescription': 'Non-steroid anti-inflammatory drugs are recommended for multimodal postoperative pain management.\n\nWe evaluated the effect of perioperative parecoxib administration on postoperative pain, analgesic use, function recovery, inflammatory response and bleeding risk.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female patients who have underwent primary unilateral total knee arthroplasty (TKA) and total hip arthroplasty (THA).\n2. Age between 18-65 years.\n3. Chinese ethnicity.\n\nExclusion Criteria:\n\n1. patients who underwent a reversion or a previous TKA or THA, emergency TKA, or TKA as result of a trauma.\n2. patient exhibited allergy to parecoxib sodium.\n3. lactating or pregnant.\n4. any other conditions not suitable for surgery as evaluated by the surgeon in charge.'}, 'identificationModule': {'nctId': 'NCT02272660', 'briefTitle': 'Parecoxib for Pain Management After Total Knee Arthroplasty and Total Hip Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Perioperative Parecoxib Administration for Pain Management After Total Knee Arthroplasty and Total Hip Arthroplasty-A Randomized, Placebo-controlled Trial', 'orgStudyIdInfo': {'id': 'S-503'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Parecoxib sodium', 'description': 'The patients in the parecoxib group received a single 40mg dose of parecoxib sodium 30 minutes before incision.', 'interventionNames': ['Drug: Parecoxib sodium']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal saline injection', 'description': 'The control group received 2 mL normal saline injection at the same time point.', 'interventionNames': ['Drug: Normal saline injection']}], 'interventions': [{'name': 'Parecoxib sodium', 'type': 'DRUG', 'otherNames': ['Dynastat'], 'description': 'The patients in the parecoxib group received a single 40mg dose of parecoxib sodium 30 minutes before incision, 9:00 pm on the operation day as well as 9:00 am and 9:00 pm for the next two days after the operation, along with PCIA morphine.', 'armGroupLabels': ['Parecoxib sodium']}, {'name': 'Normal saline injection', 'type': 'DRUG', 'otherNames': ['Physiological saline'], 'description': 'The patients in the control group received 2 mL normal saline injection 30 minutes before Normal saline injection incision, 9:00 pm on the operation day as well as 9:00 am and 9:00 pm for the next two days after the operation, along with PCIA morphine.', 'armGroupLabels': ['Normal saline injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100005', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'The Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Zhihong Wu, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PUMC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof', 'investigatorFullName': 'Zhihong Wu', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}