Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-03-09 @ 1:57 AM
Study NCT ID:
NCT04337060
Status:
COMPLETED
Last Update Posted:
2021-12-27
First Post:
2020-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open Radical Prostatectomy and Erector Spinae Plane Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010268', 'term': 'Parapsychology'}, {'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D001525', 'term': 'Behavioral Sciences'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-23', 'studyFirstSubmitDate': '2020-04-03', 'studyFirstSubmitQcDate': '2020-04-06', 'lastUpdatePostDateStruct': {'date': '2021-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Narcotic consumption in the first 24 hours after surgery', 'timeFrame': 'Postoperative day 1', 'description': 'Morphine consumption in the first 24 hours will be measured by IV PCA. Patients will be able to request opioids via a PCA device when their NRS score is above 3.'}], 'secondaryOutcomes': [{'measure': 'Postoperative pain: NRS score', 'timeFrame': 'Postoperative day 1', 'description': 'Pain status at rest and while coughing will be assessed by NRS score at 1, 3, 6, 12, 18, and 24 hours after surgery. In addition, the time until first analgesic requirement will be recorded.The NRS is an 11-point numeric scale which ranges from 0 to 10.'}, {'measure': 'Postoperative nausea and vomiting (PONV)', 'timeFrame': 'Postoperative day 1', 'description': 'The patients will be verbally evaluated according to a descriptive five-point PONV scale. If a score of 3 or more is registered, ondansetron 4 mg IV will be administered and repeated after 8 hours if required.The PONV scale is 0 = no nausea; 1 = slight nausea; 2 = moderate nausea; 3 = vomiting once;and 4 = vomiting more than once'}, {'measure': 'Intraoperative remifentanil consumption', 'timeFrame': 'Postoperative day 1', 'description': 'Following anesthesia induction, a bispectral index (BIS) of 40 to 50 will be maintained with sevoflurane. When the BIS measures 40-50, the remifentanil infusion rate will be adjusted to consider ±20% blood pressure changes compared to baseline values.The total amount of remifentanil consumed will be recorded.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pain, Postoperative', 'Ultrasound Guided Erector Spinae Plane Block', 'Prostatectomy'], 'conditions': ['Prostate Cancer', 'Anesthesia, Local', 'Pain, Postoperative']}, 'referencesModule': {'references': [{'pmid': '31620856', 'type': 'BACKGROUND', 'citation': 'Ibrahim M, Elnabtity AM. Analgesic efficacy of erector spinae plane block in percutaneous nephrolithotomy : A randomized controlled trial. Anaesthesist. 2019 Nov;68(11):755-761. doi: 10.1007/s00101-019-00673-w. Epub 2019 Oct 16.'}, {'pmid': '27501016', 'type': 'BACKGROUND', 'citation': 'Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.'}, {'pmid': '28188621', 'type': 'BACKGROUND', 'citation': 'Chin KJ, Adhikary S, Sarwani N, Forero M. The analgesic efficacy of pre-operative bilateral erector spinae plane (ESP) blocks in patients having ventral hernia repair. Anaesthesia. 2017 Apr;72(4):452-460. doi: 10.1111/anae.13814. Epub 2017 Feb 11.'}, {'pmid': '32076689', 'type': 'BACKGROUND', 'citation': 'Diwan S, Nair A. Is Paravertebral-Epidural Spread the Underlying Mechanism of Action of Erector Spinae Plane Block? Turk J Anaesthesiol Reanim. 2020 Feb;48(1):86-87. doi: 10.5152/TJAR.2019.81226. Epub 2019 Nov 11. No abstract available.'}, {'pmid': '30886130', 'type': 'BACKGROUND', 'citation': 'Kot P, Rodriguez P, Granell M, Cano B, Rovira L, Morales J, Broseta A, Andres J. The erector spinae plane block: a narrative review. Korean J Anesthesiol. 2019 Jun;72(3):209-220. doi: 10.4097/kja.d.19.00012. Epub 2019 Mar 19.'}, {'pmid': '31031480', 'type': 'BACKGROUND', 'citation': 'Tulgar S, Kapakli MS, Kose HC, Senturk O, Selvi O, Serifsoy TE, Thomas DT, Ozer Z. Evaluation of Ultrasound-Guided Erector Spinae Plane Block and Oblique Subcostal Transversus Abdominis Plane Block in Laparoscopic Cholecystectomy: Randomized, Controlled, Prospective Study. Anesth Essays Res. 2019 Jan-Mar;13(1):50-56. doi: 10.4103/aer.AER_194_18.', 'retractions': [{'pmid': '34092875', 'source': 'Anesth Essays Res. 2020 Jul-Sep;14(3):544'}]}, {'pmid': '30988534', 'type': 'BACKGROUND', 'citation': 'Singh S, Kumar G, Akhileshwar. Ultrasound-guided erector spinae plane block for postoperative analgesia in modified radical mastectomy: A randomised control study. Indian J Anaesth. 2019 Mar;63(3):200-204. doi: 10.4103/ija.IJA_758_18.'}]}, 'descriptionModule': {'briefSummary': 'In the proposed study, a bilateral erector spinae plane (ESP) block \\[10 ml 1%lidocaine + 10 ml 0.5 % bupivacaine vs normal saline (NS)\\] will be performed preoperatively to patients undergoing open radical prostatectomy. Analgesic efficacy will be assessed on the numeric rating scale (NRS) along with intra- and 24 h post-operative narcotic consumption.', 'detailedDescription': 'It has been reported that the ESP block produces effective postoperative analgesia for abdominal surgeries by relieving both somatic and visceral pain. In the present study, the investigators presume that an ESP block will decrease narcotic consumption and NRS values both intraoperatively and during the first 24 postoperative hours.\n\nPatients will be divided into two groups:\n\nGroup LB (Lidocaine-Bupivacaine): A bilateral ESP block will be performed preoperatively (10 ml 1%lidocaine + 10 ml 0.5% bupivacaine). In addition, IV morphine patient-controlled analgesia (PCA) will be applied postoperatively for 24 hours.\n\nGroup S: A bilateral ESP block will be performed preoperatively (20 ml NS).In addition, IV morphine-PCA will be applied postoperatively for 24 hours.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Only Male', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: AmericanSociety of Anesthesiologists (ASA) I-III patients between the ages of 18 and 65 who are scheduled for elective open radical prostatectomy.\n\nExclusion criteria:\n\n* Patients who do not give informed consent or do not want to participate in the study\n* Ages \\<18 or\\>65\n* ASA IV patients\n* Obesity (\\>100 kg, BMI \\>35 kg/m2)\n* Contraindications of regional anesthesia (coagulopathy, thrombocytopenia, or infection at injection site)\n* Serious renal, cardiac, or hepatic disease\n* Hypersensitivity to local anesthetics or a history of allergy\n* History of opioid or steroid use longer than four weeks\n* Psychiatric disorders\n* Analgesic preoperative treatment within the preceding 48 hours\n* In order to establish better standard surgery, operations shorter than 60 minutes and longer than 180 minutes will also be excluded'}, 'identificationModule': {'nctId': 'NCT04337060', 'briefTitle': 'Open Radical Prostatectomy and Erector Spinae Plane Block', 'organization': {'class': 'OTHER', 'fullName': 'Ondokuz Mayıs University'}, 'officialTitle': 'Single-injection Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Open Radical Prostatectomy: A Prospective Randomized Sham-controlled Trial', 'orgStudyIdInfo': {'id': 'ESP0255'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group LB', 'description': 'Ultrasound-guided bilateral erector spinae plane block (10 ml 1% lidocaine + 10 ml 0.5% bupivacaine) + intravenous morphine patient-controlled analgesia.', 'interventionNames': ['Procedure: Single-injection ultrasound-guided bilateral erector spinae plane block-Lidocaine/Bupivacaine', 'Other: Pain follow-up and monitorization']}, {'type': 'SHAM_COMPARATOR', 'label': 'Group S', 'description': 'Ultrasound-guided bilateral erector spinae plane block. block (20 ml Normal Saline) + intravenous morphine patient-controlled analgesia.', 'interventionNames': ['Procedure: Single-injection ultrasound-guided bilateral erector spinae plane (ESP) block-Sham', 'Other: Pain follow-up and monitorization']}], 'interventions': [{'name': 'Single-injection ultrasound-guided bilateral erector spinae plane (ESP) block-Sham', 'type': 'PROCEDURE', 'otherNames': ['ESP block-Sham'], 'description': 'With the patient in the sitting position, 20 ml normal saline will be administered between the T11 spinous process and the erector spinae muscles with the guidance of an ultrasound probe placed on a parasagittal plane.\n\nIntraoperative analgesia: after anesthesia induction, paracetamol 1 gr intravenous (IV)+ tenoxicam 20 mg IV + morphine 0.05 mg/kg IV (max 4 mg).\n\nPostoperative analgesia: IV morphine patient-controlled analgesia (PCA) of 0.5 mg/ml morphine (demand dose 1 mg; lockout interval 8 m; 6 mg/h limit).', 'armGroupLabels': ['Group S']}, {'name': 'Single-injection ultrasound-guided bilateral erector spinae plane block-Lidocaine/Bupivacaine', 'type': 'PROCEDURE', 'otherNames': ['ESP block-Lidocaine/Bupivacaine'], 'description': 'With the patient in the sitting position, 10 ml 1% lidocaine + 10 ml 0.5% bupivacaine will be administered between the T11 spinous process and the erector spinae muscles with the guidance of an ultrasound probe placed on a parasagittal plane.\n\nIntraoperative analgesia: After anesthesia induction, paracetamol 1 gr IV + tenoxicam 20 mg IV + morphine 0.05 mg/kg IV (max 4 mg).\n\nPostoperative analgesia: IV PCA of 0.5 mg/ml morphine (demand dose 1 mg; lockout interval 8 m; 6 mg/h limit).', 'armGroupLabels': ['Group LB']}, {'name': 'Pain follow-up and monitorization', 'type': 'OTHER', 'otherNames': ['IV morphine-PCA'], 'description': 'Numeric Rating Scale (NRS) pain score will be recorded from 15th minute in recovery room followed by 1.-3.-6.-12.-18.-24.hours with two different conditions which are at rest and while couching.If NRS score becomes ≥4 Dexketoprofen 50 mg will be administered (max 4 times).', 'armGroupLabels': ['Group LB', 'Group S']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55139', 'city': 'Samsun', 'state': 'Atakum', 'country': 'Turkey (Türkiye)', 'facility': 'Ondokuz Mayis University', 'geoPoint': {'lat': 41.27976, 'lon': 36.3361}}], 'overallOfficials': [{'name': 'BURHAN DOST', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ondokuz Mayis University, School of Medicine, Department of Anesthesiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BURHAN DOST', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ondokuz Mayıs University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'BURHAN DOST', 'investigatorAffiliation': 'Ondokuz Mayıs University'}}}}