Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-31 @ 2:45 PM
Study NCT ID:
NCT04162951
Status:
COMPLETED
Last Update Posted:
2023-10-24
First Post:
2019-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrolaminar Thoracic Paravertebral Block
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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The participants and the investigator will be kept blinded by the aid of closed sealed envelops.\n\nThe measurements will be collected by the aid of assistant resident who will not participating into the study and blinded to it.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-10-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-21', 'studyFirstSubmitDate': '2019-09-09', 'studyFirstSubmitQcDate': '2019-11-12', 'lastUpdatePostDateStruct': {'date': '2023-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The postoperative rescue analgesia consumption', 'timeFrame': 'The first 24 hours postoperatively', 'description': 'Morphine consumption in the first 24 h postoperatively (3 mg morphine i.v will be given when the postoperative VAS score was 4 or more considering the total dose consumption in the first postoperative day not exceeding 15 mg.'}], 'secondaryOutcomes': [{'measure': 'The incidence of complications', 'timeFrame': 'up 24 hours from performing the technique', 'description': 'The incidence of complication pleural puncture, pneumothorax, hypotension, or intravascular injection .'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Retrolaminar', 'Paravertebral', 'Breast surgery', 'Postoperative pain'], 'conditions': ['Regional Anesthesia Morbidity', 'Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'This clinical study will be conducted on female patients admitted to The General Surgery Department of Tanta Faculty of Medicine for a period of 9 months.\n\nPatients will be randomly allocated into one of the following two groups;- • Ordinary approach group (30 patients): The patients in this group will receive ordinary ultrasound-guided thoracic paravertebral block.\n\n• Retro-laminar approach group (30 patients): The patients in this group will be receive real ultrasound-guided Retrolaminar thoracic paravertebral block.\n\nAll the patients will receive general anesthesia with attachment to a monitor (5 ASA Monitoring) In addition to bispectral index.', 'detailedDescription': 'This prospective randomized controlled study will be carried out on female patients who will be presented for breast surgery in the General Surgery Department in Tanta university hospitals over 3 month duration and 6 months follow up that starts immediately after obtaining ethical committee approval, an informed written consent will be obtained from all the participants, all patients data will be confidential and will be used for the current study only.\n\nAny unexpected risks that will appear during the research will be announced to the participants and to the ethical committee at time and adequate measures will be taken to resolve and avoid these risks.\n\nExpected risks to the patients: patients enrolled in this study will have a very minimal risk of pleural puncture that will be managed by adequate observation and chest tube insertion whenever indicated. They may have a minimal risk of hypotension that will be managed by intravenous fluids and intravenous ephedrine 10 mg.\n\nThere will be adequate supervision to maintain the privacy of patients and confidentiality of data that will be used in the current study only.\n\nThere will be no conflict of interest, nor conflict with religion, law, or society standards.\n\nThe research will be beneficial to the society and has no risk of environmental pollution.\n\nOnce the patients will arrive to the operating room, intravascular access will be established, fluid preload will be started, and basic monitor will be attached. After positioning and adequate sterilization of the back. The patients will be randomly allocated into two equal groups by the aid of computer-generated software of randomization; - • Ordinary approach group (30 patients): The patients in this group will receive ordinary ultrasound-guided thoracic paravertebral block.\n\n• Retro-laminar approach group (30 patients): The patients in this group will be receive real ultrasound-guided Retrolaminar thoracic paravertebral block.\n\nAnesthesia will be induced by fentanyl 1.5 ug/kg, propofol 1.5 mg/kg, and cis-atracurium 0.15 mg/kg to facilitate tracheal intubation. After endotracheal intubation, the patients will be connected to a mechanical ventilator with its parameters adjusted to maintain etCo2 34-38 mmhg. Anesthesia will be maintained by isoflurane 1.5% in mixture of oxygen:air 1:1 with the use of low flow (1 ml/min).\n\nAll the patients will be connected to a bispectral index monitor with maintaining its value ranging 40-60. Increase in the BIS value over 60 will be managed by additional dose of fentanyl 1ug/kg till decrease the BIS below 60. If the BIS is still over 60, increasing the isoflurane 0.2 % MAC till it decreased below 60.\n\nAt the end of the surgery, switching off the inhalational anesthetics, reversal of muscle relaxation, and awake tracheal extubation will be done with transporting the patients to the PACU for postoperative follow up and monitoring.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients\n* Aged 40-60 years\n* ASA class I-II.\n* Presented for elective breast surgery.\n\nExclusion Criteria:\n\n* Patients refused to participate\n* Patients with known or suspected or known allergy to the used medication.\n* Patients with spinal deformities.\n* Patients with preoperative chronic pain,\n* Patients received preoperative opioids or gabapentoids.\n* Patients with major cardiac, renal, respiratory, or hepatic disease.\n* Patients with suspected or diagnosed coagulopathy\n* Uncooperative patients.\n* Obese patients with BMI \\>36'}, 'identificationModule': {'nctId': 'NCT04162951', 'briefTitle': 'Retrolaminar Thoracic Paravertebral Block', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'The Effect of Retrolaminar Thoracic Paravertebral Block on the Postoperative Analgesia of Patients Undergoing Breast Surgeries: Prospective Randomized Double Blinded Study', 'orgStudyIdInfo': {'id': '33207/07/19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ordinary approach group', 'description': 'The patients in this group will receive ordinary ultrasound-guided thoracic paravertebral block. by local anesthetic mixture at a volume of 0.2 ml/kg composed of plain bupivacaine 0.25% and Fentanyl 2 ug/ml.', 'interventionNames': ['Procedure: Ordinary approach paravertebral block']}, {'type': 'EXPERIMENTAL', 'label': 'Retro-laminar approach group', 'description': 'The patients in this group will be receive real ultrasound-guided Retrolaminar thoracic paravertebral block by local anesthetic mixture at a volume of 0.2 ml/kg composed of plain bupivacaine 0.25% and Fentanyl 2 ug/ml.', 'interventionNames': ['Procedure: Retrolaminar paravertebral block']}], 'interventions': [{'name': 'Ordinary approach paravertebral block', 'type': 'PROCEDURE', 'otherNames': ['thoracic paravvertebral blovk'], 'description': "Ultrasound guided thoracic paravertebral block. At the appropriate dermatome, the needle (22-gauge, 8-10-cm, short bevelled spinal needle, or a Touhy needle if a catheter is to be placed) is inserted 2.5-3 cm lateral to the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process at a variable depth (2-4 cm) depending on the build of the individual. The needle is then walked above the transverse process and gradually advanced until a loss of resistance to air or saline, or a subtle 'click' is felt as the superior costotransverse ligament is penetrated, usually within 1-1.5 cm from the superior edge of the transverse process.", 'armGroupLabels': ['Ordinary approach group']}, {'name': 'Retrolaminar paravertebral block', 'type': 'PROCEDURE', 'otherNames': ['Thoracic retrolaminar paravertebral block'], 'description': 'In the retrolaminar approach to TPVB or retrolaminar block (RB), local anesthetic (LA) is injected into the retrolaminar plane to achieve a truncal sensory block like that of traditional TPVB. It has been postulated that during RB, LA spreads from the injection plane to the thoracic paravertebral space (TPVS) through the superior costotransverse ligament (SCTL). Retrolaminar block will be performed under ultrasound guidance, as a single injection.', 'armGroupLabels': ['Retro-laminar approach group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31511', 'city': 'Tanta', 'country': 'Egypt', 'facility': 'Tanta University hospitals', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'overallOfficials': [{'name': 'Sameh Ismaiel, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lecturer of Anesthesia and Intensive Care, Tanta University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Once the study had been successfully completed, the data will be shared for other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Sameh Abdelkhalik Ahmed Ismaiel', 'investigatorAffiliation': 'Tanta University'}}}}