Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2026-03-05 @ 11:00 AM
Study NCT ID:
NCT03229668
Status:
COMPLETED
Last Update Posted:
2020-03-31
First Post:
2017-07-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Pregabalin Administration on Catheter- Related Bladder Discomfort in Urological Surgical Operations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069583', 'term': 'Pregabalin'}], 'ancestors': [{'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, double-blind,randomized, placebo controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-28', 'studyFirstSubmitDate': '2017-07-18', 'studyFirstSubmitQcDate': '2017-07-22', 'lastUpdatePostDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of postsurgical catheter-related bladder discomfort after preoperative pregabalin administration', 'timeFrame': 'Change from preoperative status to postoperative one at 0, 1, 2, 6, 24 hours postoperatively', 'description': 'Assessment of discomfort will be made by a scale of four (1=no discomfort, 2=mild discomfort reported on questioning only, 3=moderate discomfort, urge to pass urine reported by the patient without questioning, 4= severe discomfort, urge to pass urine accompanied by behavioral responses, such as flailing limbs, strong vocal responses or attempts to pull the catheter out)'}], 'secondaryOutcomes': [{'measure': 'Postoperative pain assessed by NPRS scale (Numeric Pain Rating Scale)', 'timeFrame': 'Total amount of analgesics in morphine analogues administered in the first 24 hours postoperatively', 'description': 'The goal is to achieve pain scores\\<3 as these are assessed by the NPRS scale. In order to achieve that we will record the total amount of milligrams of analogues of morphine administered in the first 24 hours postoperatively'}, {'measure': 'Adverse effects of the drug', 'timeFrame': 'All adverse effects observed in the first 24 hours postoperatively', 'description': 'Postoperative nausea and vomiting, confusion, vertigo, blurred vision, dry mouth,sedation, dizziness'}, {'measure': 'Assessment of postoperative sedation', 'timeFrame': "In the operating theatre immediately after patient's extubation", 'description': 'The Ramsay Sedation Scale is used to measure different levels of sedation in medical patients (1=Patient is anxious and agitated or restless, or both 2=Patient is co-operative, oriented, and tranquil, 3=Patient responds to commands only, 4=Patient exhibits brisk response to light glabellar tap or loud auditory stimulus, 5=Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus, 6=Patient exhibits no response)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['urinary bladder', 'urinary catheters', 'pregabalin'], 'conditions': ['Pregabalin on Catheter Related Bladder Discomfort']}, 'referencesModule': {'references': [{'pmid': '16415311', 'type': 'BACKGROUND', 'citation': 'Agarwal A, Dhiraaj S, Singhal V, Kapoor R, Tandon M. Comparison of efficacy of oxybutynin and tolterodine for prevention of catheter related bladder discomfort: a prospective, randomized, placebo-controlled, double-blind study. Br J Anaesth. 2006 Mar;96(3):377-80. doi: 10.1093/bja/ael003. Epub 2006 Jan 16.'}, {'pmid': '25200037', 'type': 'BACKGROUND', 'citation': 'Srivastava VK, Agrawal S, Kadiyala VN, Ahmed M, Sharma S, Kumar R. The efficacy of pregabalin for prevention of catheter-related bladder discomfort: a prospective, randomized, placebo-controlled double-blind study. J Anesth. 2015 Apr;29(2):212-6. doi: 10.1007/s00540-014-1911-x. Epub 2014 Sep 9.'}, {'pmid': '22749555', 'type': 'BACKGROUND', 'citation': 'Tauzin-Fin P, Stecken L, Sztark F. [Catheter-related bladder discomfort in post-anaesthesia care unit]. Ann Fr Anesth Reanim. 2012 Jul-Aug;31(7-8):605-8. doi: 10.1016/j.annfar.2012.03.009. Epub 2012 Jun 29. French.'}, {'pmid': '25335575', 'type': 'BACKGROUND', 'citation': 'Bai Y, Wang X, Li X, Pu C, Yuan H, Tang Y, Li J, Wei Q, Han P. Management of Catheter-Related Bladder Discomfort in Patients Who Underwent Elective Surgery. J Endourol. 2015 Jun;29(6):640-9. doi: 10.1089/end.2014.0670. Epub 2014 Dec 9.'}, {'pmid': '23869107', 'type': 'BACKGROUND', 'citation': 'Ryu JH, Hwang JW, Lee JW, Seo JH, Park HP, Oh AY, Jeon YT, Do SH. Efficacy of butylscopolamine for the treatment of catheter-related bladder discomfort: a prospective, randomized, placebo-controlled, double-blind study. Br J Anaesth. 2013 Dec;111(6):932-7. doi: 10.1093/bja/aet249. Epub 2013 Jul 17.'}, {'pmid': '16531445', 'type': 'BACKGROUND', 'citation': 'Agarwal A, Gupta D, Kumar M, Dhiraaj S, Tandon M, Singh PK. Ketamine for treatment of catheter related bladder discomfort: a prospective, randomized, placebo controlled and double blind study. Br J Anaesth. 2006 May;96(5):587-9. doi: 10.1093/bja/ael048. Epub 2006 Mar 10.'}, {'pmid': '18653496', 'type': 'BACKGROUND', 'citation': 'Agarwal A, Yadav G, Gupta D, Singh PK, Singh U. Evaluation of intra-operative tramadol for prevention of catheter-related bladder discomfort: a prospective, randomized, double-blind study. Br J Anaesth. 2008 Oct;101(4):506-10. doi: 10.1093/bja/aen217. Epub 2008 Jul 24.'}, {'pmid': '25304838', 'type': 'BACKGROUND', 'citation': 'Nam K, Seo JH, Ryu JH, Oh AY, Lee T, Park HP, Jeon YT, Hwang JW. Randomized, clinical trial on the preventive effects of butylscopolamine on early postoperative catheter-related bladder discomfort. Surgery. 2015 Feb;157(2):396-401. doi: 10.1016/j.surg.2014.05.017. Epub 2014 Oct 8.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the effect of pregabalin administration on catheter-related bladder discomfort (CRBD). The study group includes patients that are about to be subjected to urological operations because of the high incidence of CRBD observed in this kind of surgical population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients about to be subjected to urinary operations\n* Signed informed consent\n\nExclusion Criteria:\n\n* Preoperative urinary bladder/kidney dysfunction as a result of spinal cord pathology\n* History of overactive ((urinary frequency\\>3 times at night and \\>8 times in 24 hours), neurogenic bladder\n* End stage renal failure\n* Central nervous system dysfunction\n* Mental illness/ substance abuse\n* Sensitivity to pregabalin\n* Preoperative administration of pregabalin for other indications\n* Recent bladder catheterization \\<3 months'}, 'identificationModule': {'nctId': 'NCT03229668', 'briefTitle': 'Effect of Pregabalin Administration on Catheter- Related Bladder Discomfort in Urological Surgical Operations', 'organization': {'class': 'OTHER', 'fullName': 'Saint Savvas Anticancer Hospital'}, 'officialTitle': 'Effect of Pregabalin Administration on Catheter- Related Bladder Discomfort in Urological Surgical Operations', 'orgStudyIdInfo': {'id': 'CRBD urologic operations'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Group I', 'description': 'Administration of a placebo capsule 1 hour prior to the surgical operation', 'interventionNames': ['Drug: Placebo oral capsule']}, {'type': 'EXPERIMENTAL', 'label': 'Group II', 'description': 'Administration of 75mg of pregabalin 1 hour prior to the surgical operation', 'interventionNames': ['Drug: Pregabalin Oral Capsule [Lyrica] 75mg']}, {'type': 'EXPERIMENTAL', 'label': 'Group III', 'description': 'Administration of 150mg of pregabalin 1 hour prior to the surgical operation', 'interventionNames': ['Drug: Pregabalin Oral Capsule [Lyrica] 150 mg']}], 'interventions': [{'name': 'Placebo oral capsule', 'type': 'DRUG', 'description': 'Placebo oral capsule administered 1 hour prior to the surgical operation', 'armGroupLabels': ['Group I']}, {'name': 'Pregabalin Oral Capsule [Lyrica] 75mg', 'type': 'DRUG', 'otherNames': ['Pregabalin'], 'description': 'Pregabalin Oral Capsule \\[Lyrica\\] 75 mg administered 1 hour prior to the surgical operation', 'armGroupLabels': ['Group II']}, {'name': 'Pregabalin Oral Capsule [Lyrica] 150 mg', 'type': 'DRUG', 'otherNames': ['Pregabalin'], 'description': 'Pregabalin Oral Capsule \\[Lyrica\\] 150 mg administered 1 hour prior to the surgical operation', 'armGroupLabels': ['Group III']}]}, 'contactsLocationsModule': {'locations': [{'zip': '115 22', 'city': 'Athens', 'country': 'Greece', 'facility': 'Anticancer Hospital of Athens "Saint Savvas"', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '38221', 'city': 'Volos', 'country': 'Greece', 'facility': 'University of Thessaly, Medical School', 'geoPoint': {'lat': 39.36923, 'lon': 22.94769}}], 'overallOfficials': [{'name': 'Eleni Arnaoutoglou, Prof Of Anesthesiology', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Thessaly, Medical School, Anesthesiology Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saint Savvas Anticancer Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Thessaly', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesiologist,MD, MSc, PhD', 'investigatorFullName': 'Georgia Micha', 'investigatorAffiliation': 'Saint Savvas Anticancer Hospital'}}}}