Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-04-17 @ 4:52 AM
Study NCT ID:
NCT03032458
Status:
COMPLETED
Last Update Posted:
2018-05-29
First Post:
2017-01-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Pethidine, Ketorolac And Xylocaine Gel As Analgesics For Pain Control In Shockwave Lithotripsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D052878', 'term': 'Urolithiasis'}], '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'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008614', 'term': 'Meperidine'}, {'id': 'D020910', 'term': 'Ketorolac'}], 'ancestors': [{'id': 'D007540', 'term': 'Isonipecotic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D007213', 'term': 'Indomethacin'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 165}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-24', 'studyFirstSubmitDate': '2017-01-10', 'studyFirstSubmitQcDate': '2017-01-25', 'lastUpdatePostDateStruct': {'date': '2018-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain control __ Outcome Measure by "pain assessment scales of The National Initiative on Pain Control™ (NIPC™)"', 'timeFrame': '10 months'}], 'secondaryOutcomes': [{'measure': 'Effect of anxiety on success of SWL __ Outcome Measure by "Generalized Anxiety Disorder 7-item "', 'timeFrame': '10 months'}, {'measure': 'Effect of anxiety on success of SWL __ Outcome Measure by "The Patient Health Questionnaire (PHQ-9)"', 'timeFrame': '10 months'}, {'measure': 'Compare stone free rate __ Outcome Measure by "ultrasound and plain x-ray" 1 week after session. If no residual stone, NCCT scan.', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Shock Wave Lithotripsy', 'Ketorolac', 'Xylocaine Gel', 'Pethidine'], 'conditions': ['Analgesia', 'Urolithiasis']}, 'descriptionModule': {'briefSummary': 'A randomised prospective trial comparing the efficacy of pethidine, Ketorolac, and Xylocaine gel as analgesics for pain control in shockwave lithotripsy.', 'detailedDescription': "Pain perception during shockwave lithotripsy (SWL) is affected by patient-related factors like age, gender, and body habitus moreover, young female patients, anxious and depressed patients or thin patients experience more pain during SWL.\n\nSeveral physical variables influencing treatment-related pain have been identified: the type of the shockwave source, size, and site of stone burden, peak pressure of the shockwaves, diameter of the focal zone, and size of the aperture of the shockwave source reflecting the area of shockwave entry at the skin.\n\nPain relief during SWL is vital, not only to maintain patient comfort and satisfaction, but also to facilitate stone imaging and targeting by reducing patients' movements during successive shock wave impacts. Reduced patient movement enables increase fragmentation efficiency and reduce the risk of procedure-related morbidity. So, a relaxed, cooperative patient during treatment is paramount in maintaining stone targeting for optimal fragmentation.\n\nAcross 21 centers in the United Kingdom (UK), 17 distinct analgesia regimens were reported in SWL analgesia practice.\n\nIn 2016 European Association of Urology (EUA) guidelines for SWL Pain control stated that pain control during SWL is necessary to limit pain induced movements and excessive respiratory excursions, However no recommendation for proper analgesia in contrast to clear recommendation for Pain relief in patients with an acute stone episode.\n\nThe investigators will try in this trial to identify the best efficacious type of analgesia for patient during SWL in this study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with renal and upper ureteral stones amenable to SWL.\n\nExclusion Criteria:\n\n* Allergy to pethidine.\n* Allergy to Ketorolac.\n* Allergy to Xylocaine gel.\n* American Society of Anesthesiologists score ≥ 3 (ASA III or more).\n* Pregnancy.\n* Patients with a pacemaker.\n* Bleeding diatheses.\n* Uncontrolled urinary tract infection (UTI).\n* Severe obesity which prevent targeting of the stone.\n* Body Mass IndexBMI (40 or more)\n* Arterial aneurysm in the vicinity of the stone.\n* Anatomical obstruction distal to the stone.'}, 'identificationModule': {'nctId': 'NCT03032458', 'briefTitle': 'Efficacy of Pethidine, Ketorolac And Xylocaine Gel As Analgesics For Pain Control In Shockwave Lithotripsy', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Efficacy of Pethidine, Ketorolac And Xylocaine Gel As Analgesics For Pain Control In Shockwave Lithotripsy Single Blinded Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'MD/16.11.72'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pethidine', 'description': 'Pethidine 25 mg IV bolus (Pethidine hydrochloride 50mg ampule, Roche Pharmaceutical Company - Egypt)', 'interventionNames': ['Drug: Pethidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ketorolac', 'description': 'Ketolac 30 mg (ketorolac, Amriya Pharmaceutical Industries - Egypt)', 'interventionNames': ['Drug: Ketorolac']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Xylocaine Gel', 'description': 'Xylocaine gel (lidocaine 2%, AstraZeneca Pharmaceutical Company - Egypt)', 'interventionNames': ['Drug: Xylocaine Gel']}], 'interventions': [{'name': 'Pethidine', 'type': 'DRUG', 'otherNames': ['Pethidine 50'], 'description': "pethidine 25 mg IV bolus injection before start of session plus placebo gel then then IV infusion, so that the total dose doesn't exceed 1mg/kg", 'armGroupLabels': ['Pethidine']}, {'name': 'Ketorolac', 'type': 'DRUG', 'otherNames': ['Ketolac'], 'description': "ketorolac IV bolus injection before start of session plus placebo gel then 30 mg IV infusion so that total dose doesn't exceed 60 mg.", 'armGroupLabels': ['Ketorolac']}, {'name': 'Xylocaine Gel', 'type': 'DRUG', 'otherNames': ['lidocaine 2%'], 'description': 'Xylocaine gel locally 15 minutes before session with 10 mg normal saline IV bolus before session then IV normal saline infusion then', 'armGroupLabels': ['Xylocaine Gel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'Aldakahlia', 'country': 'Egypt', 'facility': 'Urology and Nephrology Center', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Hassan Abol-Enein, MD, Phd', 'role': 'STUDY_CHAIR', 'affiliation': 'Urology and Nephrology Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'meta-analyses by contact the Prof. Hassan Abol-Enein, MD, Phd (Study Chair) or Prof. Khaled Z. Sheir, MD ( Study Central Contact Backup)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Urology Msc, Oncology fellow at Urology and Nephrology Center, Principal Investigator', 'investigatorFullName': 'Abdelwahab Hashem', 'investigatorAffiliation': 'Mansoura University'}}}}