Ignite Creation Date:
2025-12-24 @ 12:23 PM
Ignite Modification Date:
2025-12-27 @ 10:41 PM
Study NCT ID:
NCT04396561
Status:
COMPLETED
Last Update Posted:
2020-06-16
First Post:
2020-05-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Unilateral Ultrasound Guided Paravertebral Block as Perioperative Analgesia For Lower Limb-Sparing Surgery In Adult Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'sealed opaque envelopes prepared by an assistant blinded about the study targets and chosen by patient him/herself, allocated into two groups'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective randomized controlled double-blind study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-14', 'studyFirstSubmitDate': '2020-05-11', 'studyFirstSubmitQcDate': '2020-05-18', 'lastUpdatePostDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total intraoperative fentanyl consumption.', 'timeFrame': '24 hours', 'description': 'Total intraoperative fentanyl consumption.'}], 'secondaryOutcomes': [{'measure': 'Visual Analouge Scale at 0 , 4 , 8 ,12 ,24 hours postoperatively.', 'timeFrame': '24 hours', 'description': 'Visual Analouge Scaleat 0 , 4 , 8 ,12 ,24 hours postoperatively.The VAS consists of a 10-cm line, with anchors at either end. One end is marked "no pain" and the other end is marked "the worst imaginable pain". The patient marks the place on the line to indicate his or her pain intensity. The clinician then measures the line with a ruler and assigns a score.'}, {'measure': 'Heart rate and mean arterial blood pressure .', 'timeFrame': '24 hours', 'description': 'Heart rate(beat per minutes) and mean arterial blood pressure(mm HG)'}, {'measure': 'Morphine consumption postoperatively for 24 hours..', 'timeFrame': '24 hours Postoperative', 'description': 'Morphine consumption per mg postoperatively for 24 hours..'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Unilateral U/S PVB']}, 'descriptionModule': {'briefSummary': 'Ultrasound imaging has revolutionized the practice of regional anesthesia in that the operator can visualize and identify the paravertebral space, needle during its passage through the tissues, as well as deposition and spread of local anesthetic into the desired spaces. The usage of ultrasound may facilitate more rapid block onset and prolong duration with the added advantage of decrease in drug dosage, reduction in incidence of local anesthetic toxicity, increase success rate, reduction in procedure pain and better patient satisfaction.', 'detailedDescription': "Paravertebral block targets drug delivery to the site of pain, thus decreasing opioids use. It can provide greater overall comfort with lower pain scores and greater tolerance of physical activity during the initial postoperative period.\n\nUltrasound imaging has revolutionized the practice of regional anesthesia in that the operator can visualize and identify the paravertebral space, needle during its passage through the tissues, as well as deposition and spread of local anesthetic into the desired spaces. The usage of ultrasound may facilitate more rapid block onset and prolong duration with the added advantage of decrease in drug dosage, reduction in incidence of local anesthetic toxicity, increase success rate, reduction in procedure pain and better patient satisfaction.\n\nTo the best of researchers' knowledge, evaluation of unilateral ultrasound guided paravertebral block as perioperative analgesia for lower limb-sparing surgery in adult cancer patients was not investigated before."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Physical status ASA II and III.\n2. Age ≥ 18 and ≤ 65 Years.\n3. Body mass index (BMI): \\> 20 kg/m2 and \\< 40 kg/m2.\n4. Patient undergoing lower limb-sparing surgery for cancer surgeries under general anesthesia.\n\nExclusion Criteria:\n\n1. Patient refusal.\n2. Known sensitivity or contraindication to local anesthetics.\n3. History of psychological disorders and/or chronic pain.\n4. Coagulopathies with INR ≥1.5: hereditary (e.g. hemophilia, fibrinogen abnormalities \\& deficiency of factor II) - acquired (e.g. impaired liver functions with PC less than 60 %, vitamin K deficiency \\& therapeutic anticoagulants drugs).\n5. Significant liver or renal insufficiency.\n6. Localized infection at the site of block.'}, 'identificationModule': {'nctId': 'NCT04396561', 'briefTitle': 'Evaluation of Unilateral Ultrasound Guided Paravertebral Block as Perioperative Analgesia For Lower Limb-Sparing Surgery In Adult Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Evaluation of Unilateral Ultrasound Guided Paravertebral Block as Perioperative Analgesia For Lower Limb-Sparing Surgery In Adult Cancer Patients: A Prospective, Randomized, Controlled Study', 'orgStudyIdInfo': {'id': 'MS-270-2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Paravertebral group (group P):', 'description': 'After induction of general anesthesia and stabilization of the patients, they were positioned in lateral decubitus position with the side to be blocked uppermost.', 'interventionNames': ['Drug: Paravertebral group (group P):']}, {'type': 'EXPERIMENTAL', 'label': 'Control group (group C):', 'description': 'Patients underwent surgery under general anesthesia and received the perioperative routine protocol of analgesia (IV fentanyl 2 μcg/kg at induction and 1 gm of IV paracetamol).', 'interventionNames': ['Drug: Paravertebral group (group P):']}], 'interventions': [{'name': 'Paravertebral group (group P):', 'type': 'DRUG', 'otherNames': ['Control group (group C):'], 'description': 'In both groups, one reading of mean arterial pressure and heart rate were taken before induction of general anaesthesia and were defined as baseline readings and then were recorded intra-operatively at 15 min intervals.\n\nAdditional bolus doses of fentanyl 0.5µg/kg were given when the mean arterial blood pressure or heart rate raised above 20% of baseline levels.', 'armGroupLabels': ['Control group (group C):', 'Paravertebral group (group P):']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11451', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ahmed Abdalla Mohamed', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Ahmed Abdalla Mohamed, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}, {'name': 'Enas Mohamed Samir, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}, {'name': 'Walaa Y Elsabeeny, M.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Cancer Institute, Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Until ending the investigator's work"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Anesthesia &I.C.U and Pain Clinic, Cairo University', 'investigatorFullName': 'Ahmed Abdalla', 'investigatorAffiliation': 'Cairo University'}}}}