Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2025-12-31 @ 10:07 PM
Study NCT ID:
NCT03866733
Status:
COMPLETED
Last Update Posted:
2021-01-15
First Post:
2019-03-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuous Erector Spinea Block Versus Intravenous Analgesia in Coronary Bypass Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009294', 'term': 'Narcotics'}, {'id': 'D000894', 'term': 'Anti-Inflammatory Agents, Non-Steroidal'}], 'ancestors': [{'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000700', 'term': 'Analgesics'}, {'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D018712', 'term': 'Analgesics, Non-Narcotic'}, {'id': 'D000893', 'term': 'Anti-Inflammatory Agents'}, {'id': 'D018501', 'term': 'Antirheumatic Agents'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-14', 'studyFirstSubmitDate': '2019-03-03', 'studyFirstSubmitQcDate': '2019-03-06', 'lastUpdatePostDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'effectiveness of perioperative analgesia', 'timeFrame': '48 hours after surgery', 'description': 'total dose of perioperative narcotics'}], 'secondaryOutcomes': [{'measure': 'extubation time', 'timeFrame': '12 hours after end of surgery', 'description': 'time passed between end of surgery and removal of endotracheal tube'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['erector spinea block, open heart surgeries,analgesia'], 'conditions': ['Erector Spinea Block in Open Heart Surgery']}, 'referencesModule': {'references': [{'pmid': '18201893', 'type': 'BACKGROUND', 'citation': 'Fibla JJ, Molins L, Mier JM, Sierra A, Vidal G. Comparative analysis of analgesic quality in the postoperative of thoracotomy: paravertebral block with bupivacaine 0.5% vs ropivacaine 0.2%. Eur J Cardiothorac Surg. 2008 Mar;33(3):430-4. doi: 10.1016/j.ejcts.2007.12.003. Epub 2008 Jan 16.'}, {'pmid': '24319854', 'type': 'BACKGROUND', 'citation': 'Raksamani K, Wongkornrat W, Siriboon P, Pantisawat N. Pain management after cardiac surgery: are we underestimating post sternotomy pain? J Med Assoc Thai. 2013 Jul;96(7):824-8.'}, {'pmid': '16394700', 'type': 'BACKGROUND', 'citation': 'Hansdottir V, Philip J, Olsen MF, Eduard C, Houltz E, Ricksten SE. Thoracic epidural versus intravenous patient-controlled analgesia after cardiac surgery: a randomized controlled trial on length of hospital stay and patient-perceived quality of recovery. Anesthesiology. 2006 Jan;104(1):142-51. doi: 10.1097/00000542-200601000-00020.'}, {'pmid': '11426357', 'type': 'BACKGROUND', 'citation': 'Dhole S, Mehta Y, Saxena H, Juneja R, Trehan N. Comparison of continuous thoracic epidural and paravertebral blocks for postoperative analgesia after minimally invasive direct coronary artery bypass surgery. J Cardiothorac Vasc Anesth. 2001 Jun;15(3):288-92. doi: 10.1053/jcan.2001.23271.'}, {'pmid': '12688271', 'type': 'BACKGROUND', 'citation': 'Canto M, Sanchez MJ, Casas MA, Bataller ML. Bilateral paravertebral blockade for conventional cardiac surgery. Anaesthesia. 2003 Apr;58(4):365-70. doi: 10.1046/j.1365-2044.2003.03082_2.x.'}]}, 'descriptionModule': {'briefSummary': 'Adequate postoperative pain relief in patients in cardiac surgery is very essential. multimodal techniques for perioperative pain management post cardiac surgery include intravenous patient controlled analgesia, thoracic epidural and paravertebral blockade. Analgesia through thoracic epidural is the gold standard technique for post-sternotomy pain control but it has serious complications. ESP block is an easy technique compared to paravertebral block and less hazardous than thoracic epidural. Hence, this study will compare continuous bilateral erector spinae block guided by ultrasound with intravenous analgesia which is the standard method for pain management in cardiac surgery.', 'detailedDescription': "Analgesia through thoracic epidural is the gold standard technique for post-sternotomy pain control. in spite of its serious complications such as epidural hematoma with or without paraplegia that enhanced by heparin administered during cardiac bypass surgery..\n\nParavertebral blockade is comparable to Thoracic epidural analgesia in cardiac surgery but it may cause complications such as vascular injuries and pneumothorax.\n\nErector spinae block is recently implemented technique for treatment and analgesia of thoracic neuropathic pain and post mastectomy syndrome. ESP block is an easy technique compared to paravertebral block and less hazardous than thoracic epidural.\n\nThis study will compare continuous bilateral erector spinae block guided by ultrasound versus intravenous analgesia for pain management in cardiac surgery Patients will be enrolled in the study will be divided into two groups In Group A: 20 patients will receive fentanyl after induction and intubation in the dose of ( 3-52mcg/kg ) according to the patients haemodynamic parameters and the decision of the anaesthesia team at skin incision, before starting Cardiopulmonary bypass and again after bypass and before sternal closure. Once the surgical procedure is finished, patients will be transferred to ICU. After ICU transfer acetaminophen 1 gm/6hrs will be given regularly and NSAID if there is no contraindication after extubation. morphine 0.5mg/kg as rescue analgesia will be started upon arrival till extubation.\n\nIn Group B: 20 patients will have bilateral ESP block will be done under general anaesthesia bolus dose 15 ml of 0.25% bupivacaine will be injected in each of the catheters followed by a continuous infusion of 0.125% plain bupivacaine at the rate of 8 ml/h starting in ICU for 48 h after extubation. patients will receive intraoperative boluses of fentanyl according to the patients' haemodynamic and the decision of the anaesthesia team at skin incision, before starting Cardiopulmonary bypass and again after bypass and before sternal closure. Once the surgical procedure is finished, patients will be transferred to ICU morphine 0.5mg/kg as rescue analgesia will be started upon arrival till extubation. Infusion rate will be titrated according to haemodynamics, pain assessment, and complications. After extubation acetaminophen 1gm/6hrs will be given regularly."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elective cardiac surgery.\n* age 18-65 years.\n* patients with median sternotomy.\n* body mass index \\<30kg.m2.\n* left ventricular ejection fraction \\>50%.\n\nExclusion Criteria:\n\n* significant aortic stenosis.\n* left main coronary artery disease.\n* patient on anti-coagulants0\n* pre-existing respiratory, neurological, or renal disease.\n* CSF or blood tap during the procedure.\n* failure to thread the catheter.\n* anomalies of vertebral column.'}, 'identificationModule': {'nctId': 'NCT03866733', 'briefTitle': 'Continuous Erector Spinea Block Versus Intravenous Analgesia in Coronary Bypass Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Lecturer of Anesthesia, Intensive Care and Pain Management in Ain Shams University', 'orgStudyIdInfo': {'id': 'R07l2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Narcotics group (group N)', 'description': 'intervention: injection of boluses of intra venous Narcotics (fentanyl) in the dose of (3-5 mcg/kg) during the surgery after induction of anesthesia. morphine 0.5mg/kg as rescue analgesia will be started upon arrival till 48 hours after surgery. NSAID every 12 hrs if there is no contraindication and iv acetaminophine igm/6hrs.', 'interventionNames': ['Drug: intravenous narcotics']}, {'type': 'EXPERIMENTAL', 'label': 'Erector spinea block group (group B)', 'description': 'intervention: after induction our intervention will be the performance of ultrasound guided bilateral continous Erector spinea block with insertion of catheters then 15 ml of 0.25% bupivacaine will be injected in each of the catheters followed by a continuous infusion of 0.125% plain bupivacaine at the rate of 8 ml/h. morphine 0.5mg/kg as rescue analgesia will be started upon arrival till extubation and iv acetaminophine igm/6hrs.', 'interventionNames': ['Other: continous erector spinea block']}], 'interventions': [{'name': 'continous erector spinea block', 'type': 'OTHER', 'description': 'Ultrasound guided erector spinea block will be performed while the patient is in left lateral position ) the US probe will be placed in longitudinal parasagittal plane lateral to the T5 spinous process. An 18-gauge epidural needle will be inserted in-plane in a cranial-to-caudal direction until the tip is deep to erector spinae muscle. A 5 cm of epidural catheter will be threaded in cephalad direction. The same steps will be performed on the other side, after the negative aspiration for blood, bolus dose 15 ml of 0.25% bupivacaine will be injected in each of the catheters followed by a continuous infusion of 0.125% plain bupivacaine at the rate of 0.1 ml/kg/h.', 'armGroupLabels': ['Erector spinea block group (group B)']}, {'name': 'intravenous narcotics', 'type': 'DRUG', 'otherNames': ['iv narcotics and NSAID'], 'description': 'intervention: injection of boluses of intra venous Narcotic drugs (fentanyl) in the dose of (1-2mcg/kg) during the surgery after induction of anesthesia then fentanyl infusion through the postoperative first 24 hours postoperative till extubation then intravenous pethidine till 48 hours after surgery.', 'armGroupLabels': ['Narcotics group (group N)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11835', 'city': 'Cairo', 'state': 'New Cairo', 'country': 'Egypt', 'facility': 'Sanaa Farag Mahmoud', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'zip': '11591', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ainshams hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of aneathesia', 'investigatorFullName': 'Sanaa Farag Mahmoud Wasfy', 'investigatorAffiliation': 'Ain Shams University'}}}}