Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-02-21 @ 6:20 AM
Study NCT ID:
NCT02598102
Status:
COMPLETED
Last Update Posted:
2018-08-28
First Post:
2015-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Preprocedural Diclofenac in Males Undergoing Double J Stent Removal Under Local Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004008', 'term': 'Diclofenac'}], 'ancestors': [{'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-27', 'studyFirstSubmitDate': '2015-11-04', 'studyFirstSubmitQcDate': '2015-11-04', 'lastUpdatePostDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain', 'timeFrame': 'Intraoperative upto 24 hours postoperative', 'description': 'Pain during stent removal, first void and 24 hours after procedure'}], 'secondaryOutcomes': [{'measure': 'Adverse reactions', 'timeFrame': '24 hours', 'description': 'Adverse reactions to diclofenac sodium'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '15798411', 'type': 'RESULT', 'citation': 'Chen YT, Hsiao PJ, Wong WY, Wang CC, Yang SS, Hsieh CH. Randomized double-blind comparison of lidocaine gel and plain lubricating gel in relieving pain during flexible cystoscopy. J Endourol. 2005 Mar;19(2):163-6. doi: 10.1089/end.2005.19.163.'}, {'pmid': '28197031', 'type': 'DERIVED', 'citation': 'Karthikeyan VS, Keshavamurthy R, Mallya A, Chikka Moga Siddaiah M, Kumar S, Chandrashekar CR. Efficacy of preprocedural diclofenac in men undergoing double J stent removal under local anesthesia: A double-blind, randomized control trial. Indian J Urol. 2017 Jan-Mar;33(1):53-57. doi: 10.4103/0970-1591.194783.'}]}, 'descriptionModule': {'briefSummary': 'Double J (DJ) stents are placed following upper urinary tract surgeries. DJ stents are usually removed under local anesthesia using rigid cystoscope. Patients experience a lot of pain during this procedure and also continue to have discomfort during voiding for few days. The use of lignocaine jelly during this procedure is not very effective. Use of diclofenac suppository during flexible cystoscopy has been proven to be effective. This study was done to assess the effect of oral diclofenac in pain relief in patients undergoing DJ stent removal by rigid cystoscopy when compared to placebo and to assess its safety in these patients', 'detailedDescription': 'Consecutive consenting male patients undergoing DJ stent removal under local anesthesia during 2014-15 were enrolled. Patients were randomized to receive 75 mg oral diclofenac or placebo 1 hour prior to procedure by double blind randomization. Intraurethral 2% lignocaine jelly (25 ml) was used in both groups. Pain during rigid cystoscopy, pain at first void and at 24 hours after cystoscopy was assessed using visual analogue scale \\[VAS\\] (0 to 100). Adverse reactions to diclofenac and episodes of acute urinary retention, if any, were assessed.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll consecutive consenting male patients aged more than 18 years, undergoing DJ stent removal under local anesthesia (2% Lignocaine jelly) during the study period will be included.\n\nExclusion Criteria:\n\n* Patients unable to understand visual analogue pain score\n* Age \\< 18 years\n* Presence of Lower Urinary Tract Symptoms prior to surgery\n* Presence of prostatitis or urethral stricture during cystoscopy\n* Patients with renal failure (Serum creatinine \\> 1.3 mg/dl)\n* Patients on concomitant nephrotoxic drugs\n* Patients with history of peptic ulcer or upper gastrointestinal bleed or upper abdominal surgeries\n* Loss to follow up at 24 hours following DJ stent removal'}, 'identificationModule': {'nctId': 'NCT02598102', 'briefTitle': 'Efficacy of Preprocedural Diclofenac in Males Undergoing Double J Stent Removal Under Local Anesthesia', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Institute of Nephro Urology, Bangalore'}, 'officialTitle': 'Efficacy of Preprocedural Diclofenac in Males Undergoing Double J Stent Removal Under Local Anesthesia', 'orgStudyIdInfo': {'id': 'INU/RRC/01/2014-15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diclofenac sodium', 'description': 'Oral diclofenac 75 mg one hour prior to stent removal', 'interventionNames': ['Drug: Diclofenac sodium']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo one hour prior to stent removal', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Diclofenac sodium', 'type': 'DRUG', 'otherNames': ['Voveran'], 'description': 'Diclofenac for pain relief', 'armGroupLabels': ['Diclofenac sodium']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo for comparison', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '560002', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Institute of Nephro Urology', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}], 'overallOfficials': [{'name': 'VS Karthikeyan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Postgraduate in Urology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Nephro Urology, Bangalore', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MCh Urology Postgraduate in Urology', 'investigatorFullName': 'Vilvapathy Senguttuvan Karthikeyan', 'investigatorAffiliation': 'Institute of Nephro Urology, Bangalore'}}}}