Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-27 @ 10:16 PM
Study NCT ID:
NCT01566669
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
2012-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Parecoxib on Morphine Patient-controlled Epidural Analgesia (PCEA) After Gynecologic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, 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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 294}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-20', 'studyFirstSubmitDate': '2012-03-18', 'studyFirstSubmitQcDate': '2012-03-27', 'lastUpdatePostDateStruct': {'date': '2012-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'morphine-sparing effect of parecoxib', 'timeFrame': 'within 48 h after skin closure', 'description': 'The primary end-point of this study was to quantify the morphine-sparing effect of a multimodal approach containing parecoxib compared with the standard PCEA approach in patients undergoing abdominal hysterectomy.'}], 'secondaryOutcomes': [{'measure': 'pain intensity and side effects accompanied with PCEA and parecoxib', 'timeFrame': 'within 48 h after skin closure', 'description': "The secondary outcome included pain intensity, the patients' global evaluation, and side effects accompanied with PCEA and parecoxib, such as nausea, vomiting, pruritus, sedation, motor block in the lower extremities, and the time to passage of flatus and first bowel movement.Blood loss, length of hospitalization, and postoperative cardiovascular (CV) events were also recorded."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cyclooxygenase inhibitors', 'Morphine', 'Analgesia', 'patient-controlled', 'Gynecologic surgical procedures'], 'conditions': ['Benign Female Reproductive System Neoplasm']}, 'referencesModule': {'references': [{'pmid': '27622453', 'type': 'DERIVED', 'citation': 'Liu WF, Shu HH, Zhao GD, Peng SL, Xiao JF, Zhang GR, Liu KX, Huang WQ. Effect of Parecoxib as an Adjunct to Patient-Controlled Epidural Analgesia after Abdominal Hysterectomy: A Multicenter, Randomized, Placebo-Controlled Trial. PLoS One. 2016 Sep 13;11(9):e0162589. doi: 10.1371/journal.pone.0162589. eCollection 2016.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effects of parecoxib in combination with epidural morphine in providing analgesia for patients undergoing gynecological surgery.', 'detailedDescription': 'Researches have showed that the use of epidural and spinal block resulted in significant reduction in morbidity and mortality after surgery. Moreover, appropriate pain management results in better outcomes. Opioids therapy is recommended as the first choice medication for the management of postoperative pain but is associated with a number of undesirable adverse effects. A multimodal therapy for providing postoperative analgesia has advantages over the use of opioids alone. The use of NSAIDs and opioids together often improves analgesia and reduces the need for opioids in the postoperative period. Often, the combination of COX-2 inhibitors with epidural analgesia is preferred. With epidural analgesia, addition of COX-2 inhibitors may improve the analgesia and decrease the undesirable side effects.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women scheduled for elective gynecological surgery under combined spinal-epidural anesthesia\n\nExclusion Criteria:\n\n* contraindications for CSE placement\n* known allergy, sensitivity, or contraindication to opioid and nonopioid analgesic drugs\n* history of bleeding disorders, peptic ulceration, or anticoagulant use within the past month\n* current pregnancy or breastfeeding\n* history of known or suspected drug abuse\n* unable to understand the use of pain assessment scales and the PCA device\n* Patient with asthma or bronchospasm, requiring treatment with glucocorticoids\n* poorly controlled hypertension or diabetes, a chronic or acute renal or hepatic disorder, or inflammatory bowel disease\n* patients had taken antidepressants, narcotic analgesics, antihistamines, anxiolytics, hypnotics, sedatives, NSAIDs, or corticosteroids up to 24 h before receipt of the study medication'}, 'identificationModule': {'nctId': 'NCT01566669', 'acronym': 'PCEA', 'briefTitle': 'Efficacy and Safety of Parecoxib on Morphine Patient-controlled Epidural Analgesia (PCEA) After Gynecologic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital, Sun Yat-Sen University'}, 'officialTitle': 'A Multicenter, Randomised, Double-blinded, Placebo-controlled Trial Comparing the Efficacy and Safety of Intravenous Parecoxib Sodium on Morphine Patient-controlled Epidural Analgesia After Gynecologic Surgery', 'orgStudyIdInfo': {'id': 'PCEA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Normal Saline', 'description': 'Before incision, patients in controlled Group received NS', 'interventionNames': ['Drug: Normal saline']}, {'type': 'EXPERIMENTAL', 'label': 'parecoxib sodium', 'description': 'Before incision, parecoxib patients received 40mg of parecoxib IV', 'interventionNames': ['Drug: Parecoxib Sodium']}], 'interventions': [{'name': 'Parecoxib Sodium', 'type': 'DRUG', 'otherNames': ['Dynastat'], 'description': 'Before incision, patients in Group P (n = 120) receive 40mg of parecoxib IV. Thereafter, parecoxib patients receive 40mg of parecoxib IV every 12 h for 48 h. 30 min before the end of surgery, a mixture of 6 mL of ropivacaine 0.25% and 2mg morphine was given epidurally. Epidural patient-controlled analgesia was initiated by using ropivacaine 0.125% (1.25 mg/ml) and morphine 0.005% (0.05 mg/ml) with a basal infusion rate of 2 ml/h, a demand dose of 2 ml, and a 15-min lockout.', 'armGroupLabels': ['parecoxib sodium']}, {'name': 'Normal saline', 'type': 'DRUG', 'otherNames': ['NS'], 'description': 'Before incision, patients in Group C (n = 120) receive 2 mL of normal saline IV. Thereafter, they receive 2 mL of normal saline IV every 12 h for 48 h. 30 min before the end of surgery, a mixture of 6 mL of ropivacaine 0.25% and 2mg morphine was given epidurally. Epidural patient-controlled analgesia was initiated by using ropivacaine 0.125% (1.25 mg/ml) and morphine 0.005% (0.05 mg/ml) with a basal infusion rate of 2 ml/h, a demand dose of 2 ml, and a 15-min lockout.', 'armGroupLabels': ['Normal Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The First Affiliated Hospital of Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Wenqi Huang, postgraduate', 'role': 'STUDY_CHAIR', 'affiliation': 'The First Affliated Hospital, Sun Yet-Sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Liu Weifeng', 'class': 'OTHER'}, 'collaborators': [{'name': "Guangdong Provincial People's Hospital", 'class': 'OTHER'}, {'name': 'Second Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'attending doctor', 'investigatorFullName': 'Liu Weifeng', 'investigatorAffiliation': 'First Affiliated Hospital, Sun Yat-Sen University'}}}}