Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT05044858
Status:
UNKNOWN
Last Update Posted:
2021-10-01
First Post:
2021-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultrasound-Guided Mid-Point Transverse Process to Pleura Block for Thoracotomy Incisions
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-09-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-25', 'studyFirstSubmitDate': '2021-09-09', 'studyFirstSubmitQcDate': '2021-09-09', 'lastUpdatePostDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The degree of Postoperative Pain', 'timeFrame': '24 hours postoperative', 'description': 'Postoperative pain will be assessed by the Numerical Rating Scale (NRS;0 no pain while 10 is the maximum pain) at 0,4,8,12,18, 24 hours during rest and cough. If the (NRS) is 4 or more, morphine 3mg will be titrated until pain relief is achieved using a short interval between boluses'}], 'secondaryOutcomes': [{'measure': 'The amount of Postoperative morphine consumption', 'timeFrame': '24 hours Postoperative', 'description': 'Total morphine consumption at 24 hours after surgery'}, {'measure': 'Time to the first rescue analgesia request', 'timeFrame': '24 hours Postoperative', 'description': 'Time till administration of first rescue analgesia'}, {'measure': 'SpO2/FiO2 ratio', 'timeFrame': '24 hours Postoperative', 'description': 'SpO2/FiO2 ratio at 6,8,12 and 24h postoperatively'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pre-emptive', 'Postoperative Pain', 'Thoracotomy']}, 'descriptionModule': {'briefSummary': 'This study is designed to investigate the analgesic efficacy of pre-emptive ultrasound-guided midpoint transverse process to pleura (MTP) block for posterolateral thoracotomy in cardiothoracic surgeries.', 'detailedDescription': 'Preemptive preoperative analgesia was first proposed, over the years it has been gradually regarded as an intervention given before incision, facilitating mobilization and functional rehabilitation after surgery, reducing postoperative opioid consumption, decreasing the incidence of adverse events and improving patient satisfaction.\n\nThe Mid Transverse Process to Pleura block, described by Costach et al. involves deposition of drug midway between the transverse process and pleura. Costach et al. postulated that the local anesthetic deposited at this point may reach the paravertebral space through several possible mechanisms, such as spread medially through the gap between the superior costotransverse ligament (SCTL) and vertebral bodies, through fenestrations in SCTL, and laterally through the internal intercostal membrane'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 21- and65 years old\n* American Society of Anesthesiologists (ASA) II-III\n* Scheduled for posterolateral thoracotomy operation under general anesthesia\n\nExclusion Criteria:\n\n* Patients with bleeding disorders,\n* Mental or cognitive dysfunction\n* History of chronic analgesic or drug abuse\n* Allergy to local anesthetics\n* Local infection at site of block'}, 'identificationModule': {'nctId': 'NCT05044858', 'briefTitle': 'Ultrasound-Guided Mid-Point Transverse Process to Pleura Block for Thoracotomy Incisions', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Analgesic Efficacy of Pre-emptive Ultrasound-Guided Mid-Point Transverse Process to Pleura Block for Patients Undergoing Posterolateral Thoracotomy Incisions: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '34646/4/21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Midpoint transverse process block group', 'description': 'Patients will receive midpoint transverse process block after induction of general anesthesia and before surgical incision', 'interventionNames': ['Procedure: Midpoint transverse process block group']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham group', 'description': 'Patients will receive general anesthesia and the same intervention steps will be performed i.e., the block under investigation but instead of local anesthetic a placebo (2ml normal saline) will be injected (sham block)', 'interventionNames': ['Procedure: Sham group']}], 'interventions': [{'name': 'Midpoint transverse process block group', 'type': 'PROCEDURE', 'description': 'After marking the level of the incision by surgeon (commonly T5- T6) The patient will be situated in the lateral position, the block area will be sterilized with povidine-iodine, and high -frequency linear ultrasound probe will be placed oblique parasagittally 3 cm lateral to the spinous process at the level of skin incision. 100-mm short bevel echogenic needle (Contiplex, B.Braun, Germany) will be inserted in plane from cranial to caudal direction. The desired end point of the needle tip will be the midpoint of the line between the posterior border of transverse process and the pleura titrated bolus of 20 ml of 0.25% bupivacaine and dexamethazone 8 mg will be injected at the target site. At end of the surgery general anaesthesia will be stopped with reversal of muscle relaxation and awakening of patient', 'armGroupLabels': ['Midpoint transverse process block group']}, {'name': 'Sham group', 'type': 'PROCEDURE', 'description': 'General anesthesia will be induced with the same protocol and MTP block will be done but with injection of placebo (2 ml normal saline) instead of local anesthetic .\n\nOn arrival to the PACU postoperative Numerical Rating scale at rest and coughing will be recorded, analgesia will be maintained with intravenous paracetamol 1 g every 8 h and required additional rescue analgesia (morphine) at any time will be calculated.', 'armGroupLabels': ['Sham group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'Elgarbia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Heba A. Mohamed, M.B.B.CH', 'role': 'CONTACT', 'email': 'Heba154537_pg@med.tanta.edu.eg', 'phone': '+20 111 505 4431'}], 'facility': 'Faculty of Medicine Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Heba A. Mohamed, M.B.B.CH', 'role': 'CONTACT', 'email': 'Heba154537_pg@med.tanta.edu.eg', 'phone': '+20 111 505 4431'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'For one year after completion of the study', 'ipdSharing': 'YES', 'description': 'The data will be available upon reasonable request from the principal investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident of Anesthesiology and Surgical Intensive Care and Pain Medicine', 'investigatorFullName': 'Heba Abdelhamid Mohamed', 'investigatorAffiliation': 'Tanta University'}}}}