Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2026-02-18 @ 1:48 PM
Study NCT ID:
NCT02729935
Status:
COMPLETED
Last Update Posted:
2016-10-18
First Post:
2016-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Parecoxib for Treatment of Catheter Related Bladder Discomfort
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': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-16', 'studyFirstSubmitDate': '2016-03-31', 'studyFirstSubmitQcDate': '2016-03-31', 'lastUpdatePostDateStruct': {'date': '2016-10-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reducing of Catheter related bladder discomfort symptoms', 'timeFrame': 'at postoperatively 30th minutes, 1st, 2nd, 4th, 6th and 12th hours', 'description': 'CRBD was evaluated with a 4 point scale (1; no discomfort, 2; mild, revealed on questioning only, 3; moderate, stated by the patient without questioning, 4; severe, urinary urgency executed by behavioral responses, such as attempts to remove urinary catheter, restless extremity movements, verbal responses) at postoperatively 30th minutes, 1st, 2nd, 4th, 6th and 12th hours.'}], 'secondaryOutcomes': [{'measure': 'Severity of Pain at suprapubic area', 'timeFrame': 'at postoperative 0, 1, 6 and 12 hours', 'description': 'Assessed by Visual Analogue Scale (VAS) and rescue analgesia requirement ( Paracetamol or nefopam)'}, {'measure': 'safety and tolerability of parecoxib', 'timeFrame': 'During the first 24 hours', 'description': 'Blood loss, length of hospitalization, renal function and postoperative cardiovascular (CV) events'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Parecoxib', 'Bladder Discomfort'], 'conditions': ['Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '29962529', 'type': 'DERIVED', 'citation': 'Jendoubi A, Aissi W, Abbes A, Bouzouita A, Fourati S, Necib H, Ghedira S, Houissa M. Efficacy and safety of Parecoxib for prevention of catheter-related bladder discomfort in patients undergoing transurethral resection of bladder tumor: Prospective randomised trial. Indian J Anaesth. 2018 Jun;62(6):461-465. doi: 10.4103/ija.IJA_137_18.'}]}, 'descriptionModule': {'briefSummary': 'Catheter-related bladder discomfort (CRBD) is defined as an urge to void or discomfort in the supra-pubic region; reported postoperatively in patients who have had urinary catheterization intra-operatively. In the present study, the investigators evaluated Parecoxib (P) for preventing CRBD in patients undergoing catheterization after transurethral resection of bladder tumor (TURBT).', 'detailedDescription': "Participants will be randomized into one of two study groups: Group P: 40 mg of intravenous parecoxib 30 min before surgery and Control Group C: an equal volume of saline.\n\nLumber subarachnoid block was administered with 2 ml 0.5% hyperbaric bupivacaine and 2.5 µg Sufentanyl. Intra-operatively, urinary catherization was performed with a 16 Fr Foley's catheter, and the balloon was inflated with 10 ml distilled water. The CRBD was assessed at 0, 1, 2, and 6 h after patient's arrival in the post-anaesthesia care unit. Severity of CRBD was graded as none, mild, moderate and severe."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult (\\>/=18)\n2. Male or female\n3. Undergoing catheterization after transurethral resection of bladder tumor (TURBT)\n4. Under spinal anesthesia\n5. Subject is American Society of Anesthesiologists (ASA) physical status 1 or 2.\n\nExclusion Criteria:\n\n1. Patient who disagrees to participate this investigation\n2. Patient with severe cardiovascular disease\n3. Patient with small-sized foley catheter (less than 18 Fr.)\n4. Patinets with bladder outflow obstruction\n5. Patient with overactive bladder (frequency \\>3 times,in the night or \\>8 times in 24 h)\n6. Patients with chronic renal failure\n7. Patient with morbid obesity\n8. Patient with medications for chronic pain\n9. Patient with disturbance of the central nervous system'}, 'identificationModule': {'nctId': 'NCT02729935', 'briefTitle': 'Parecoxib for Treatment of Catheter Related Bladder Discomfort', 'organization': {'class': 'OTHER', 'fullName': 'University Tunis El Manar'}, 'officialTitle': 'Efficacy and Tolerance of Parecoxib for Prevention of Catheter-related Bladder Discomfort in Patients Undergoing Catheterization After TURBT: A Prospective, Randomized, Placebo-controlled, Double-blind Study', 'orgStudyIdInfo': {'id': 'University Of Tunis El Manar'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Parecoxib', 'description': '40 mg of intravenous parecoxib (DYNASTAT )30 min before surgery', 'interventionNames': ['Drug: Parecoxib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'An equal volume of saline', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Parecoxib', 'type': 'DRUG', 'otherNames': ['DYNASTAT'], 'description': '40 mg of intravenous parecoxib 30 min before surgery', 'armGroupLabels': ['Parecoxib']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Saline'], 'description': 'An equal volume of saline', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1006', 'city': 'Tunis', 'state': 'Tunis Governorate', 'country': 'Tunisia', 'facility': 'Ali JENDOUBI', 'geoPoint': {'lat': 36.81897, 'lon': 10.16579}}], 'overallOfficials': [{'name': 'Ali JENDOUBI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Tunis El Manar'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Tunis El Manar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Assistant Professor', 'investigatorFullName': 'Ali JENDOUBI', 'investigatorAffiliation': 'University Tunis El Manar'}}}}