Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2026-01-06 @ 11:12 AM
Study NCT ID:
NCT02622893
Status:
COMPLETED
Last Update Posted:
2016-02-17
First Post:
2015-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgical Approach Affect on Post-operative Analgesic Requirement Following Laparoscopic Nephrectomy
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-14', 'studyFirstSubmitDate': '2015-11-26', 'studyFirstSubmitQcDate': '2015-12-02', 'lastUpdatePostDateStruct': {'date': '2016-02-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Complications', 'timeFrame': 'up to 24 hours', 'description': 'Nausea, vomiting'}, {'measure': 'Time to first mobilization', 'timeFrame': 'up to 24 hours', 'description': 'Time to first mobilization'}, {'measure': 'Return of bowel sounds/oral intake', 'timeFrame': 'through study completion, an average of 1 week', 'description': 'Post-operative oral intake starts just after the return of bowel sounds (almost at the same time), will be assessed as hours (time to return of bowel sounds)'}, {'measure': 'Hospital stay', 'timeFrame': 'through study completion, an average of 1 week', 'description': 'Hospitalisation'}], 'primaryOutcomes': [{'measure': 'Total epidural analgesic consumption', 'timeFrame': 'up to 24 hours', 'description': 'Total epidural analgesic (bupivacaine and fentanyl) consumption from patient controlled epidural analgesia (PCEA) devices'}], 'secondaryOutcomes': [{'measure': 'Visual analog scale (VAS) scores', 'timeFrame': 'up to 24 hours', 'description': 'Visual analog scale (VAS) scores at rest and during mobilization'}, {'measure': 'Number of patients who require rescue analgesic', 'timeFrame': 'up to 24 hours', 'description': 'Number of patients who require IV tramadol (1 mg/kg) as a rescue analgesic besides PCEA use'}, {'measure': 'Hemodynamic parameters', 'timeFrame': 'up to 24 hours', 'description': 'Postoperative heart rates (HRs), systolic (SBPs)/diastolic blood pressures (DBPs)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pain, Postoperative']}, 'referencesModule': {'references': [{'pmid': '28678012', 'type': 'DERIVED', 'citation': 'Savran-Karadeniz M, Kisa I, Salviz EA, Ozkan-Seyhan T, Tefik T, Sanli O, Tugrul KM. Can surgical approach affect postoperative analgesic requirements following laparoscopic nephrectomy: Transperitoneal versus retroperitoneal? A prospective clinical study. Arch Esp Urol. 2017 Jul;70(6):603-611.'}]}, 'descriptionModule': {'briefSummary': 'Background: We performed this prospective clinical study to compare the post-operative recovery profile of our patients after transperitoneal and retroperitoneal laparoscopic nephrectomy techniques. Our primary aim was to compare post-operative epidural analgesic consumption of transperitoneal (Group T) and retroperitoneal (Group R) laparoscopic nephrectomy patients within the first 24 hours.\n\nMethods: Forty-four patients scheduled for elective transperitoneal or retroperitoneal laparoscopic nephrectomies were enrolled. All patients in both groups received epidural catheter, 2.5ml test dose of lidocaine 2% and general anesthesia induction. At the end of the surgery, patients were given 1g IV paracetamol and 10ml 0.25% bupivacaine through epidural catheters and extubated. In the post-operative care unit, patients started to receive a continuous infusion of 0,1% bupivacaine and 1µg/ml fentanyl 5ml/h with patient-controlled boluses of an additional 4ml by a patient controlled epidural analgesia (PCEA) device. They were prescribed IV tramadol 1mg/kg as a rescue analgesic (Visual analog scale (VAS)≥4). Total analgesic consumptions from PCEA devices, VAS scores at rest and during mobilization, heart rates (HRs), systolic (SBPs)/diastolic blood pressures (DBPs) at extubation (0th min-basal) and at post-operative 30th min, 2nd, 6th, 12th, 18th and 24th hours as well as number of patients who require rescue analgesic were recorded. Nausea, vomiting, time to first mobilization, return of bowel sounds and hospital stay were also documented.', 'detailedDescription': 'Background: We performed this prospective clinical study to compare the post-operative recovery profile of our patients after transperitoneal and retroperitoneal laparoscopic nephrectomy techniques. Our primary aim was to compare post-operative epidural analgesic consumption of transperitoneal (Group T) and retroperitoneal (Group R) laparoscopic nephrectomy patients within the first 24 hours.\n\nMethods: Forty-four patients scheduled for elective transperitoneal or retroperitoneal laparoscopic nephrectomies were enrolled. All patients in both groups received epidural catheter, 2.5ml test dose of lidocaine 2% and general anesthesia induction. At the end of the surgery, patients were given 1g IV paracetamol and 10ml 0.25% bupivacaine through epidural catheters and extubated. In the post-operative care unit, patients started to receive a continuous infusion of 0,1% bupivacaine and 1µg/ml fentanyl 5ml/h with patient-controlled boluses of an additional 4ml by a patient controlled epidural analgesia (PCEA) device. They were prescribed IV tramadol 1mg/kg as a rescue analgesic (Visual analog scale (VAS)≥4). Total analgesic consumptions from PCEA devices, VAS scores at rest and during mobilization, heart rates (HRs), systolic (SBPs)/diastolic blood pressures (DBPs) at extubation (0th min-basal) and at post-operative 30th min, 2nd, 6th, 12th, 18th and 24th hours as well as number of patients who require rescue analgesic were recorded. Nausea, vomiting, time to first mobilization, return of bowel sounds and hospital stay were also documented. 0th and 30th min follow-ups were recorded in PACU and patients were passed on to ward nurses. Researchers who follow the patients at PACU and on the ward were all blinded to the surgical techniques.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) physical status I-II\n* Scheduled for elective transperitoneal or retroperitoneal laparoscopic nephrectomy\n\nExclusion Criteria:\n\n* Serious heart or respiratory failure\n* Difficulty understanding the instructions for using the anesthetic infusion pump and/or pain scales\n* Contraindications to regional anesthesia (e.g., allergy to a local anesthetics, local infection, increased intracranial pressure and coagulopathy)\n* Significant neurologic disorders of the lower extremity\n* Psychiatric or cognitive disorders\n* History of substance abuse\n* Chronic opioid use\n* Patients having open nephrectomy'}, 'identificationModule': {'nctId': 'NCT02622893', 'briefTitle': 'Surgical Approach Affect on Post-operative Analgesic Requirement Following Laparoscopic Nephrectomy', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'Can Surgical Approach Affect Post-operative Analgesic Requirements Following Laparoscopic Nephrectomy: Transperitoneal Versus Retroperitoneal? A Prospective Clinical Study', 'orgStudyIdInfo': {'id': '2009/1501'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Transperitoneal laparoscopic nephrectomy', 'description': 'Patients in this group underwent transperitoneal laparoscopic nephrectomy in 45-60º modified flank position after receiving epidural catheter in the sitting position before the surgery.', 'interventionNames': ['Drug: Transperitoneal laparoscopic nephrectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Retroperitoneal laparoscopic nephrectomy', 'description': 'Patients in this group underwent retroperitoneal laparoscopic nephrectomy in lateral decubitis position after receiving epidural catheter in the sitting position before the surgery.', 'interventionNames': ['Drug: Retroperitoneal laparoscopic nephrectomy']}], 'interventions': [{'name': 'Transperitoneal laparoscopic nephrectomy', 'type': 'DRUG', 'otherNames': ['Patient controlled epidural analgesia (PCEA)'], 'description': 'After the surgery: 10 ml 0.25% bupivacaine through epidural catheters before extubation and continuous infusion of 0,1% bupivacaine and 1 µg/ml fentanyl 5 ml/h with patient-controlled boluses of an additional 4 ml, with a lockout time of 20 min and 4-h limit of 30 ml by a patient controlled epidural analgesia (PCEA) device', 'armGroupLabels': ['Transperitoneal laparoscopic nephrectomy']}, {'name': 'Retroperitoneal laparoscopic nephrectomy', 'type': 'DRUG', 'otherNames': ['Patient controlled epidural analgesia (PCEA)'], 'description': 'After the surgery: 10 ml 0.25% bupivacaine through epidural catheters before extubation and continuous infusion of 0,1% bupivacaine and 1 µg/ml fentanyl 5 ml/h with patient-controlled boluses of an additional 4 ml, with a lockout time of 20 min and 4-h limit of 30 ml by a patient controlled epidural analgesia (PCEA) device', 'armGroupLabels': ['Retroperitoneal laparoscopic nephrectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34093', 'city': 'Istanbul', 'state': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University, Department of Anesthesiology', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Meltem Savran Karadeniz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istanbul University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Anesthesiologist', 'investigatorFullName': 'Meltem Savran Karadeniz', 'investigatorAffiliation': 'Istanbul University'}}}}