Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-01-04 @ 1:29 AM
Study NCT ID:
NCT03212456
Status:
UNKNOWN
Last Update Posted:
2020-07-29
First Post:
2017-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Post-operative Biochemical Recurrence in Patients Submitted to Radical Prostatectomy Under General Opioid-free Anesthesia Compared to Conventional General Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 146}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-27', 'studyFirstSubmitDate': '2017-04-10', 'studyFirstSubmitQcDate': '2017-07-06', 'lastUpdatePostDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biochemical recurrence of prostate cancer', 'timeFrame': 'Up to 2 years after the date of the surgery', 'description': "It's going to be measured the prostate specific antigen in 4 times after the date of the surgery( 6 months, 1 year, 1 and a half year and 2 years after the surgery) to compare elevations between the two groups."}], 'secondaryOutcomes': [{'measure': 'Neutrophil-to-lymphocyte ratio', 'timeFrame': '24 hour postoperatively', 'description': 'Compare the peutrophil-to-lymphocyte ratio preoperatively and with 24 hour postoperatively between the two groups to study about inflammation.'}, {'measure': 'visual analogue pain score in the post-anaesthesia care unit', 'timeFrame': 'Up to 2 hours postoperatively', 'description': 'Compare the pain scale between the two groups in the delivery of post-anaesthesia care unit'}, {'measure': 'Rescue Morphine', 'timeFrame': 'Up to 2 hours postoperatively', 'description': 'compare the total dosis needed for pain at delivery post-anaesthesia care unit'}, {'measure': 'Satisfaction with anesthesia technique', 'timeFrame': 'Up to 2 hours postoperatively', 'description': 'compare the satisfaction (a scale from 01 to 10) with anesthesia technique between the two groups at delivery of post-anaesthesia care unit'}, {'measure': 'adverse outcomes', 'timeFrame': 'Up to 2 hours postoperatively', 'description': 'compare the postoperative adverse outcomes (such as nausea, pruritus, somnolence) between the two groups at delivery of post-anaesthesia care unit'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['general anesthesia', 'cancer recurrence', 'opioids analgesics', 'neoplasm'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '33712224', 'type': 'DERIVED', 'citation': 'Rangel FP, Auler JOC Jr, Carmona MJC, Cordeiro MD, Nahas WC, Coelho RF, Simoes CM. Opioids and premature biochemical recurrence of prostate cancer: a randomised prospective clinical trial. Br J Anaesth. 2021 May;126(5):931-939. doi: 10.1016/j.bja.2021.01.031. Epub 2021 Mar 10.'}]}, 'descriptionModule': {'briefSummary': "The use of opioids facilitates angiogenesis and has a proven action in the immune system, mainly in the reduction of natural killer cell activity, favoring the migration of neoplastic cells and inhibiting humoral and cellular immunity. These factors may contribute to recurrence and tumor metastasis.\n\nTherefore, could opioid-free anesthesia help reduce tumor recurrence? This is a prospective randomized controlled clinical trial in which patients undergoing radical prostatectomy will be evaluated by conventional means, which have moderate and high D'Amico criteria for tumor recurrence.\n\nIn the operating room, patients will be monitored, receive peripheral venoclysis and then randomized into two groups: in group I, the anesthetic induction will be done with pre oxygenation with 100% O2, propofol, cisatracurium, lidocaine and fentanyl; In group II the induction will be done with the same doses of propofol, cisatracurium, lidocaine and placebo.\n\nIn both groups maintenance of general anesthesia will be with propofol 1% target infusion controlled with model of Marsh target-controlled infusion plasma between 2.0 and 3.0 mcg / ml, ketamine, lidocaine and dexmedetomidine.\n\nBoth groups will receive blockade of the transverse plane of the ultrasound guided ultrasound, group I with placebo (saline 0.9% 20 ml on each side) and group II with ropivacaine 0.375% 20 ml on each side. And the postoperative analgesia will be based on anti-inflammatory and opioid analgesics (pca of morphine) according to the analgesic pain scale of the patients.\n\nIn the postoperative period, patients will be followed up for 2 years with serial doses of prostate specific antigen (PSA) to diagnose tumor recurrence (2 PSA measures\\> 0.2 ng / ml) and will be evaluated in relation to analgesia, need for analgesia of Rescue with morphine, satisfaction with the anesthetic technique, adverse effects (nausea and vomiting).\n\nThe primary objective is to evaluate tumor biochemical recurrence after radical prostatectomy in patients undergoing opioid anesthesia compared to patients anesthetized without opioids. The secondary objectives are to evaluate the quality of analgesia with the two techniques, patient satisfaction with perioperative period, quality of anesthetic recovery and adverse effects (nausea and vomiting, pruritus and drowsiness).\n\nThus, to answer the hypothesis raised, 146 patients will be needed (73 in each group)."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Prostate Cancer;\n* Intermediate to high risk of recurrence by D'Amico criteria (Gleason scale \\> or = 7; PSA \\> or = 10)\n\nExclusion Criteria:\n\n* Patient refuse;\n* atrioventricular blockade;\n* Coagulopathy;\n* Other procedure at same time."}, 'identificationModule': {'nctId': 'NCT03212456', 'briefTitle': 'Evaluation of Post-operative Biochemical Recurrence in Patients Submitted to Radical Prostatectomy Under General Opioid-free Anesthesia Compared to Conventional General Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Instituto do Cancer do Estado de São Paulo'}, 'officialTitle': 'Evaluation of Post-operative Biochemical Recurrence in Patients Submitted to Radical Prostatectomy Under General Opioid-free Anesthesia Compared to Conventional General Anesthesia', 'orgStudyIdInfo': {'id': 'NP 834/15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Opioid-free', 'description': 'The patients of this group will receive opioid-free anesthesia', 'interventionNames': ['Drug: opioid-free group', 'Procedure: transversus abdominal plane block with ropivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non opioid-free', 'description': 'The patients in this group will receive the same induction and maintenance drugs of the experimental group but with fentanyl 3 - 5 mcg/kg on induction and during the procedure as needed.', 'interventionNames': ['Drug: Opioid Group', 'Procedure: transversus abdominal plane block with placebo']}], 'interventions': [{'name': 'opioid-free group', 'type': 'DRUG', 'description': "We'll study if the opioid-free anesthesia can reduce the biochemical recurrence of prostate cancer.", 'armGroupLabels': ['Opioid-free']}, {'name': 'Opioid Group', 'type': 'DRUG', 'description': 'This group will receive fentanyl in the induction of anesthesia.', 'armGroupLabels': ['Non opioid-free']}, {'name': 'transversus abdominal plane block with ropivacaine', 'type': 'PROCEDURE', 'description': 'The opioid-free group will receive transversus abdominal plane block with ropivacaine 0,375% 20 ml each side', 'armGroupLabels': ['Opioid-free']}, {'name': 'transversus abdominal plane block with placebo', 'type': 'PROCEDURE', 'description': 'the non-opioid free group will receive transversus abdominal plane block with physiological solution 0,9% 20 ml each side', 'armGroupLabels': ['Non opioid-free']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01246-903', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Instituto do Cancer do Estado de Sao Paulo - Icesp', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'The following data will be available: which group the patient were randomized; BMI; PSA preoperatively, 6 months, 1 year, 1,5 year and 2 years; prostate volume; gleason scale; neutrophil-to-lymphocyte ratio preoperatively and postoperatively; bleeding; intraoperative hydration; amount of opioids in the intraoperative period; VAS pain scale in the PACU and morphine dosis in the PACU'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto do Cancer do Estado de São Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Anesthesiologist, principal investigator', 'investigatorFullName': 'Felipe Rangel', 'investigatorAffiliation': 'Instituto do Cancer do Estado de São Paulo'}}}}