Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT03565705
Status:
COMPLETED
Last Update Posted:
2019-01-28
First Post:
2018-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Spinal Anesthesia and Peri-operative Opioid Consumption in Open Abdominal Prostatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D000377', 'term': 'Agnosia'}], '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'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 636}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-10-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-25', 'studyFirstSubmitDate': '2018-04-24', 'studyFirstSubmitQcDate': '2018-06-11', 'lastUpdatePostDateStruct': {'date': '2019-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative opioid consumption', 'timeFrame': '1 day', 'description': 'Consumption of piritramid \\[mg\\] in PACU.'}], 'secondaryOutcomes': [{'measure': 'Intra-operative opioid consumption', 'timeFrame': '1 day', 'description': 'Consumption of sufentanil \\[mg\\] during surgery. Piritramid is given if NRS score is \\> 3.'}, {'measure': 'Pain maximum', 'timeFrame': '1 day', 'description': 'Postoperative pain level measured with the highest score in numeric pain rating scale (NRS)'}, {'measure': 'Postoperative recovery time', 'timeFrame': '1 day', 'description': 'Time interval between postoperative tracheal extubation and the patient reaching fit-for-discharge criteria from the PACU to the ward.'}, {'measure': 'PONV/Shivering', 'timeFrame': '1 day', 'description': 'Occurence of post-operative nausea and vomiting or shivering in PACU.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Postoperative', 'Opioid Use', 'Analgesia']}, 'referencesModule': {'references': [{'pmid': '36184629', 'type': 'DERIVED', 'citation': 'Funcke S, Schick-Bengardt X, Pinnschmidt HO, Beyer B, Fischer M, Kahl U, Nitzschke R. The impact of spinal anaesthesia on perioperative opioid consumption, postoperative pain and oncological outcome in radical retropubic prostatectomy-a retrospective before-and-after effectiveness study. Perioper Med (Lond). 2022 Oct 3;11(1):49. doi: 10.1186/s13741-022-00281-0.'}]}, 'descriptionModule': {'briefSummary': 'Retrospective analysis to assess the impact of spinal anesthesia on peri-operative opioid consumption during open abdominal prostatectomy. The authors compare the group that had spinal anesthesia in combination with propofol sedation and a laryngeal mask to the second group that underwent the same procedure in general anesthesia with tracheal intubation.', 'detailedDescription': 'Retrospective analysis to assess the impact of spinal anesthesia on peri-operative opioid consumption during open abdominal prostatectomy. The authors compare the group that had spinal anesthesia in combination with propofol sedation and a laryngeal mask to the second group that underwent the same procedure in general anesthesia with tracheal intubation.\n\n...'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We aim to include patients that are scheduled for elective, radical open abdominal prostatectomy. Thus only male patients of 18 years or older will participate. Patients with chronic pain therapy (e.g. out-of-hospital opioid therapy) will be excluded from the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elective, radical abdominal prostatectomy\n* \\>18 years\n\nExclusion Criteria:\n\n* chronic pain therapy (e.g. out-of-hospital opioid therapy)\n* laparoscopic approach'}, 'identificationModule': {'nctId': 'NCT03565705', 'acronym': 'SAPOC', 'briefTitle': 'Spinal Anesthesia and Peri-operative Opioid Consumption in Open Abdominal Prostatectomy', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'Impact of Spinal Anesthesia on Peri-operative Opioid Consumption in Open Abdominal Prostatectomy- a Retrospective Analysis', 'orgStudyIdInfo': {'id': '042017'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Spinal anesthesia with propofol sedation', 'description': 'Patients receive spinal anesthesia for analgesia to undergo open abdominal prostatectomy. Ventilation is secured via a laryngeal mask under propofol sedation and no muscular blocking is necessary.', 'interventionNames': ['Procedure: Open abdominal prostatectomy']}, {'label': 'General anesthesia', 'description': 'General anesthesia is conducted with a combination of intravenous opioid (sufentanil) and neuromuscular blocking agent for open abdominal prostatectomy. Patients receive an induction bolus of propofol, undergo tracheal intubation and maintenance of sedation by sevoflurane.', 'interventionNames': ['Procedure: Open abdominal prostatectomy']}], 'interventions': [{'name': 'Open abdominal prostatectomy', 'type': 'PROCEDURE', 'description': 'Patients undergo standardized open abdominal prostatectomy.', 'armGroupLabels': ['General anesthesia', 'Spinal anesthesia with propofol sedation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Department of Anesthesiology; Center of Anesthesiology and Intensive Care Medicine, Hamburg Eppendorf University Medical Center', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'overallOfficials': [{'name': 'Rainer Nitzschke, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinikum Hamburg-Eppendorf'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}