Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2026-01-02 @ 4:53 PM
Study NCT ID:
NCT07028957
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-23
First Post:
2025-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Low Volume Versus High Volume of Local Anesthetic in Ultrasound Guided Combined Supraclavicular and Interscalene Block for Upper Limb 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'randomized controlled double blinded study'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-19', 'studyFirstSubmitDate': '2025-06-11', 'studyFirstSubmitQcDate': '2025-06-11', 'lastUpdatePostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analgesia', 'timeFrame': 'From time of injection to end of first 24 hours', 'description': 'The primary outcome of this study will be to compare the analgesic and anesthetic effect of different volumes of local anesthetic in Ultrasound guided combined SCB with ISB for upper limb surgery. measured by Visual analogue scale score score (VAS) (0-10; with 0 means no pain and 10 means most severe pain).'}], 'secondaryOutcomes': [{'measure': 'complications of local anesthetic', 'timeFrame': 'From time of injection to end of surgery', 'description': 'Signs of local anesthetics toxicity'}, {'measure': 'complications of technique of injection', 'timeFrame': 'From time of injection to end of 24 hours postoperative', 'description': 'Complications of the technique; pneumothorax, hematoma, phrenic nerve palsy...( yes/No)'}, {'measure': 'Heart Rate (HR) beat/minute', 'timeFrame': 'before induction of anesthesia and every 15 minutes till end of surgery', 'description': 'measuring the heart rate before anesthesia, after induction of analgesia and every 15 minutes during surgery to detect any changes in the patients HR in both groups'}, {'measure': 'Mean Arterial Blood Pressure ( MAP)( mmHg)', 'timeFrame': 'Before anesthesia, after induction of analgesia and every 15 minutes during surgery', 'description': 'measuring the mean arterial pressure (MAP) before anesthesia, after induction of analgesia and every 15 minutes during surgery to detect any changes in the patients MAP in both groups'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Low volume local anesthetic for brachial plexus block', 'High volume local anesthetic', 'brachial plexus blocks', 'Ultrasound guided'], 'conditions': ['Analgesia, Postoperative', 'Complications of Treatment']}, 'referencesModule': {'references': [{'pmid': '25109160', 'type': 'BACKGROUND', 'citation': 'Falyar CR, Grossman EC. Ultrasound-guided interscalene-supraclavicular block for an intramedullary nailing of a pathologic humeral fracture: practical application of ultrasound-guided regional anesthesia. AANA J. 2014 Jun;82(3):219-22.'}, {'type': 'BACKGROUND', 'citation': "Hadzic A. Hadzic's Textbook of Regional Anesthesia and Acute Pain Management. 2nd ed. New York: McGraw-Hill; 2017. p. 44."}, {'pmid': '20565394', 'type': 'BACKGROUND', 'citation': 'Fredrickson MJ, Krishnan S, Chen CY. Postoperative analgesia for shoulder surgery: a critical appraisal and review of current techniques. Anaesthesia. 2010 Jun;65(6):608-624. doi: 10.1111/j.1365-2044.2009.06231.x.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effectiveness of low versus high volumes of local anesthetic in ultrasound-guided combined supraclavicular block (SCB) and interscalene block (ISB) for upper limb surgery. This randomized, controlled trial will assess the analgesic effectiveness of low-volume local anesthetic in these blocks.\n\nWe hypothesize that a low volume will provide similar analgesic effects to a high volume, with fewer complications. The study will involve 40 adult ASA I and ASA II patients undergoing upper limb surgery, divided into two groups: Group A (low volume) and Group B (high volume).\n\nThe primary outcome will compare intraoperative and postoperative analgesic effects of different volumes.\n\nThe secondary outcome will evaluate complications related to local anesthetics (toxicity) and injection techniques (e.g., phrenic nerve palsy, pneumothorax, hematoma).', 'detailedDescription': 'I. Study setting and location:\n\nThe study will be conducted in Souad Kafafi Universty Hospital - Misr University for Science and Technology ( MUST).\n\nII. Study population:\n\nStudy will be conducted on (40) adult ASA І \\& ASA ІІ patients who will undergo Upper limb surgery in Souad Kafafi Universty Hospital - MUST University. Patients will be divided into two equal groups; Group A; Low volume of local anesthetic and Group B; High volume of local anesthetic in Ultrasound guided combined supraclavicular and interscalene block.\n\nIII. Eligibility Criteria:\n\n1. Inclusion criteria:\n\n The study will recruit 40 ASA physical status I, II patients of both sexes, 18 - 65 years old presented for Upper limb surgery.\n2. Exclusion criteria:\n\n1\\. Refusal of patients to participate. 2. History of allergic reactions to local anesthetics. 3. Bleeding disorders with INR \\> 1.5 and/or platelets \\< 50 000. 4. Rash or signs of infection at the injection site. 5. Emergency procedure. 6. ASA ІІІ to VI patients.\n\nIV. Study Procedures\n\n1. Randomization An online randomization program will be used to generate random list and to allocate patients into two study groups: Low volume Local anesthetic group A (n=20) and High volume Local anesthetic group B (n=20) in Ultrasound guided combined supraclavicular and interscalene block for Upper limb surgery . Random allocation numbers will be concealed in opaque closed envelops. The patient and investigator performing the block and assessing study outcomes will all be blinded to the study group allocation.\n2. Study Protocol:\n\nFollowing approval from research and ethical committee of Faculty of Medicine, MUST University, The study will recruit forty ASA physical status I, II patients of both sexes, 18 - 65 years old, who will undergo upper limb surgery. A written informed consent from patients will be provided preoperatively.\n\nExclusion criteria of this study will be; refusal of the patient, trauma survey on head neck, chest and abdomen should be free, patient with neurological deficits involving upper limb, bleeding tendency, anticoagulation therapy, patients with allergy to local anesthetics, local infection at the injection site, patients on sedative or antipsychotic drugs and body mass index (BMI) \\> 35.\n\nGroup A: 20 patients, will receive ultrasound guided combined Supraclavicular Block (SCB) with 7-10 ml and Interscalene Block (ISB) with 7-10 ml.\n\nGroup B: 20 patients, will receive ultrasound guided combined Supraclavicular Block (SCB) with 15-20 ml and Interscalene Block (ISB) with 15-20 ml.\n\nThe primary outcome of this study will be to compare the analgesic effects (intraoperative and postoperative) of different volumes of local anesthetic in Ultrasound guided combined SCB with ISB for upper limb surgery.\n\nThe secondary outcome will be to assess complications of local anesthetic and techniques of injection All patients will be subjected to systematic preoperative assessment including history, examination, and investigations. Visual analogue scale score (VAS) (0-10) will be explained to all candidates where zero corresponds to no pain and 10 is indicative of the worst unbearable pain.\n\nPatient positioning and preparation for the block:\n\nOn arrival to the preparation room: A peripheral IV cannula (18 G) will be inserted in the contralateral upper limb (non-operable limb); premedication using 2 mg midazolam IV.\n\nPatients will be transferred to the operating room where basic monitoring (Electrocardiography (ECG), Non- invasive Blood Pressure (NIBP) and pulse oximetry (SpO2) will be attached. Baseline heart rate, blood pressure, oxygen saturation and respiratory rate will be recorded as pre-block values.\n\nThe patient will be placed in supine position with the head turned 45 degrees to the contralateral side. For the ultrasound-guided supraclavicular block, an ultrasound machine (Mindray China DC-N2-Diagnostic Ultrasound System) and a 10-14 MHz linear type probe will be used. After skin preparation and local anesthetic infiltration of skin, the supraclavicular fossa will be scanned to locate the subclavian artery, first rib, pleura and brachial plexus, then a 22 gauge, 9 cm, echogenic needle (B. Braun) will be advanced from lateral to medial in plane with the probe. The needle will be advanced towards the upper trunk and the "corner pocket" where the lower trunk commonly lies and the local anesthetics will be injected.\n\nFor ultrasound-guided Interscalene block, the ultrasound transducer will be placed in the axial, oblique plane at the level of the cricoid cartilage to obtain the transverse view of the brachial plexus. Nerves in the Interscalene groove appear hypoechoic, distinctly round or oval, and will be located between the anterior and middle scalene muscles. 9 cm 22 G needle will be inserted at the outer end of the ultrasound transducer after local anesthetic infiltration of the skin. The needle will be advanced in plane with the transducer; then injection will be done toward C5, C6 and C7 cervical nerve roots.\n\nAfter injection of local anesthetic the patients will be observed for the onset of both sensory and motor blockade and duration of analgesia (first request of analgesic) in both groups.\n\nPostoperative assessment and analgesic regimen:\n\nVAS score of pain will be assessed immediately postoperative in the PACU and every 6 hours for 24 hours.\n\nThe time to the first request of rescue postoperative analgesic will be "the time interval between the onset of block and the first request to postoperative analgesia". When patients first complain of pain "1st analgesia request".\n\nIn the postoperative period if patients start to complain (VAS \\>3); rescue analgesia will be given in the form of pethidine 0.5-1 mg/kg/6hours, paracetamol (Perfalgan®) 1gm IV drip/6 hours and ketorolac 30mg IV/8 hours, till VAS score become ≤ 3.\n\nV. Study outcomes\n\n1. Primary outcome Post-operative pain score by VAS scale.\n2. Secondary outcome(s)\n\n * Time to first request of postoperative rescue analgesics.\n * Perioperative hemodynamic parameters.\n * Incidence of perioperative complications.\n\nSample size Sample sizing will be based on results obtained from previous studies. Calculation of the sample size revealed that at least 18 patients in each group were needed to detect a difference in pain score and to detect the importance of Analgesia in reduction of pain in compliance as small as 1.5 times its standard deviation (SD) with a power of 0.9 and a significance level of 0.05. The sample size was increased by two patients in each group (20 patients in each group) to compensate for misinterpretations of pain score in each group.\n\nStatistical analysis The Statistical Package of Social Science software program (SPSS), version 21 (Chicago, IL, USA) will be used for all statistical comparisons. Continuous quantitative normally distributed data will be expressed as means and standard deviations (SD), while non-normally distributed data will be expressed as median and range. Qualitative nominal data will be expressed by percentage.\n\nAfter testing for normality, continuous variables will be compared using t-test or Mann-Whitney U test as appropriate. Categorical variables will be compared using Chi- squared test or Fisher\'s exact test as appropriate. correction. A pvalue \\<0.05 will be considered statistically significant'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 to 65 of both sexes\n* ASA classification I or II\n* Scheduled for upper limp surgery\n* Will be randomized 1:1 into two groups; group A; low volume local anesthetics (15-20ml) and group B; high volume local anesthetics (30-40 ml).\n\nExclusion Criteria:\n\n* Patients who refuse participation.\n* Have allergies to local anesthetics.\n* Phrenic nerve dysfunction.\n* Chronic opioid use.\n* ASA III or higher classification.\n* Coagulopathy (bleeding disorders with INR \\> 1.5 and/or platelets \\< 50 000)\n* Severe chronic obstructive pulmonary disease.\n* Local infection at the injection site'}, 'identificationModule': {'nctId': 'NCT07028957', 'briefTitle': 'Effectiveness of Low Volume Versus High Volume of Local Anesthetic in Ultrasound Guided Combined Supraclavicular and Interscalene Block for Upper Limb Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Misr University for Science and Technology'}, 'officialTitle': 'Effectiveness of Low Volume Versus High Volume of Local Anesthetic in Ultrasound Guided Combined Supraclavicular and Interscalene Block for Upper Limb Surgery; A Randomized Controlled Double Blinded Study.', 'orgStudyIdInfo': {'id': '2022/0085'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A (n=20); Low volume Local anesthetic (15-20 ml)', 'description': '20 patients, will receive ultrasound guided combined Supraclavicular Block (SCB) with 7-10 ml (3.5-5 ml bupivacaine 0.5% plus 3.5-5 ml lidocaine 2%) and Interscalene Block (ISB) with 7-10 ml (3.5-5 ml bupivacaine 0.5% plus 3.5-5 ml lidocaine 2%).', 'interventionNames': ['Procedure: Group A; Low volume local anesthetic in Ultrasound guided combined Supraclavicular and Interscalene block for Upper limb surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B: ( n=20); High volume local anesthetic ( 30-40ml)', 'description': '20 patients, will receive ultrasound guided combined Supraclavicular Block (SCB) with 15-20 ml (7.5-10 ml bupivacaine 0.5% plus 7.5-10ml lidocaine 2%) and Interscalene Block (ISB) with 15-20 ml (7.5-10 ml bupivacaine 0.5% plus 7.5-10 ml lidocaine 2%).', 'interventionNames': ['Procedure: Group B; High volume local anesthetics (30-40ml) ultrasound guided combined Supraclavicular Block (SCB) and Interscalene Block (ISB)']}], 'interventions': [{'name': 'Group A; Low volume local anesthetic in Ultrasound guided combined Supraclavicular and Interscalene block for Upper limb surgery', 'type': 'PROCEDURE', 'description': 'Group A; will receive ultrasound guided combined Supraclavicular Block (SCB) with 7-10 ml (3.5-5 ml bupivacaine 0.5% plus 3.5-5 ml lidocaine 2%) and Interscalene Block (ISB) with 7-10 ml (3.5-5 ml bupivacaine 0.5% plus 3.5-5 ml lidocaine 2%).', 'armGroupLabels': ['Group A (n=20); Low volume Local anesthetic (15-20 ml)']}, {'name': 'Group B; High volume local anesthetics (30-40ml) ultrasound guided combined Supraclavicular Block (SCB) and Interscalene Block (ISB)', 'type': 'PROCEDURE', 'description': 'Group B; High volume local anesthetics in ultrasound guided combined Supraclavicular Block (SCB) with 15-20 ml (7.5-10ml bupivacaine 0.5% plus 7.5-10 ml lidocaine 2%) and Interscalene Block (ISB) with 15-20 ml (7.5-10 ml bupivacaine 0.5% plus 7.5-10 ml lidocaine 2%).', 'armGroupLabels': ['Group B: ( n=20); High volume local anesthetic ( 30-40ml)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15525', 'city': 'Giza', 'state': 'Giza Governorate', 'country': 'Egypt', 'facility': 'Souad Kafafi University Hospital (SKUH), faculty of medicine, Misr University for Science and Technology (MUST)', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'overallOfficials': [{'name': 'Hossam S. El Din El Ashmawi, Prof. of anesthesia and pain', 'role': 'STUDY_CHAIR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'from 01/02/2026 to 31/03/2026', 'ipdSharing': 'YES', 'description': 'Demographic Information: Age, sex, race, and other relevant demographic details.\n\nBaseline Characteristics: Health status, medical history, and any pre-existing conditions prior to the trial.\n\nTreatment Assignment: Information on the intervention or treatment each participant received.\n\nOutcome Measures: Data on primary and secondary outcomes as defined in the trial protocol.\n\nAdverse Events: Reports of any side effects or adverse events experienced by participants during the trial.\n\nFollow-up Data: Information collected during follow-up periods, including long-term outcomes.', 'accessCriteria': 'Researchers:\n\nWho: Academic researchers, industry scientists, and regulatory agencies. What: Full IPD, including demographic data, treatment assignments, and outcome measures.\n\nHow: Through data sharing platforms or repositories after submitting a research proposal and obtaining necessary approvals.\n\nRegulatory Authorities:\n\nWho: Agencies like the FDA or EMA. What: Full IPD and supporting documentation for oversight and review. How: Direct access during the review process of clinical trial applications.\n\nData Sharing Initiatives:\n\nWho: Collaborating institutions and consortia. What: Aggregated or anonymized IPD for meta-analyses or systematic reviews. How: Via established partnerships and shared databases.\n\nPublic and Patient Advocacy Groups:\n\nWho: Organizations seeking to promote transparency. What: Summary data and aggregated results, but not individual-level data. How: Through publicly available reports or dashboards.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Misr University for Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of anesthesia & pain management', 'investigatorFullName': 'Emad Lotfy Mohammed Ahmed', 'investigatorAffiliation': 'Misr University for Science and Technology'}}}}