Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2025-12-25 @ 7:01 PM
Study NCT ID:
NCT04784104
Status:
UNKNOWN
Last Update Posted:
2021-03-05
First Post:
2021-03-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Infraclavicular And Supraclavicular Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D000377', 'term': 'Agnosia'}], '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'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D011318', 'term': 'Prilocaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study covers 2 groups. Supraclavicular block will be applied to the first group and infraclavicular block will be applied to the second group.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-03-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-02', 'studyFirstSubmitDate': '2021-03-02', 'studyFirstSubmitQcDate': '2021-03-02', 'lastUpdatePostDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Block Formation Time', 'timeFrame': '30th minute pre-operatively', 'description': 'Block formation time will be defined as the time required to initiate anesthesia and analgesia in all 5 distal nerves.'}, {'measure': 'Block Application Time', 'timeFrame': 'During Block Application', 'description': 'Block application time will be defined as the time from the moment the needle passes the skin until the local anesthetic is given and withdrawn.'}, {'measure': 'Block success', 'timeFrame': 'At the 30th minute of LA application', 'description': 'Block success; at the 30th minute of local anesthesic application, the pinprick test will define the presence of insensibility or only a sense of touch in the musculocutaneous, radial, ulnar, median, cutaneous antebrachii nerves. If any of these nerves are not blocked, it will be considered a failed block.'}, {'measure': 'Sensory Block Level 5th minute', 'timeFrame': '5th minute', 'description': 'Sensory block level; axillary, median, radial, ulnar, musculocutaneous, cutaneous brachia, and cutaneous antebrachii medialis nerve level will be evaluated with the pinprick test and its level will be recorded. (0 = painful, no block; 1 = partial block-analgesia, only tactile sensation; 2 = complete block, no pain).'}, {'measure': 'Sensory Block Level 10th minute', 'timeFrame': '10th minute', 'description': 'Sensory block level; axillary, median, radial, ulnar, musculocutaneous, cutaneous brachia, and cutaneous antebrachii medialis nerve level will be evaluated with the pinprick test and its level will be recorded. (0 = painful, no block; 1 = partial block-analgesia, only tactile sensation; 2 = complete block, no pain).'}, {'measure': 'Sensory Block Level 15th minute', 'timeFrame': '15th minute', 'description': 'Sensory block level; axillary, median, radial, ulnar, musculocutaneous, cutaneous brachia, and cutaneous antebrachii medialis nerve level will be evaluated with the pinprick test and its level will be recorded. (0 = painful, no block; 1 = partial block-analgesia, only tactile sensation; 2 = complete block, no pain).'}, {'measure': 'Sensory Block Level 20th minute', 'timeFrame': '20th minute', 'description': 'Sensory block level; axillary, median, radial, ulnar, musculocutaneous, cutaneous brachia, and cutaneous antebrachii medialis nerve level will be evaluated with the pinprick test and its level will be recorded. (0 = painful, no block; 1 = partial block-analgesia, only tactile sensation; 2 = complete block, no pain).'}, {'measure': 'Sensory Block Level 25th minute', 'timeFrame': '25th minute', 'description': 'Sensory block level; axillary, median, radial, ulnar, musculocutaneous, cutaneous brachia, and cutaneous antebrachii medialis nerve level will be evaluated with the pinprick test and its level will be recorded. (0 = painful, no block; 1 = partial block-analgesia, only tactile sensation; 2 = complete block, no pain).'}, {'measure': 'Sensory Block Level 30th minute', 'timeFrame': '30th minute', 'description': 'Sensory block level; axillary, median, radial, ulnar, musculocutaneous, cutaneous brachia, and cutaneous antebrachii medialis nerve level will be evaluated with the pinprick test and its level will be recorded. (0 = painful, no block; 1 = partial block-analgesia, only tactile sensation; 2 = complete block, no pain).'}], 'secondaryOutcomes': [{'measure': 'The Motor Block Level 10th minute', 'timeFrame': '10th minute', 'description': 'The motor block will be evaluated with a Modified Bromage Scale. ( 0: No blocks, he can lift his arm; 1: Arm is weak but active; 2: Arm is motionless but fingers are active; 3: Complete block, no movement in hand or arm. )'}, {'measure': 'Postoperative Analgesia Time', 'timeFrame': '24 hours post-operatively', 'description': 'Postoperative analgesia time; It will be considered as when the NRS (Numeric Rating Scale) is≥1.'}, {'measure': 'Pain Score Follow-up 2nd Hour', 'timeFrame': '2nd hour', 'description': "Pain Score Follow-up; patients' pain scores will be recorded by checking their NRS (Numeric Rating Scale) scores at the 2nd hour."}, {'measure': 'Block Return Time', 'timeFrame': '24 hours postoperatively', 'description': "Sensory (the time from local anaesthetic injection until the patient fully perceives the upper limb) and motor (the time from local anaesthetic injection until the patient's upper extremity regains full muscle strength) block time will be recorded as the block return time."}, {'measure': 'Patient and Surgeon Satisfaction', 'timeFrame': 'Immediately after the surgery', 'description': 'Patient and surgeon satisfaction will be evaluated as 1 = complete dissatisfaction, 2 = moderate dissatisfaction, 3 = moderate satisfaction 4 =full satisfaction, after the procedure.'}, {'measure': 'Undesirable Side Effects', 'timeFrame': '24 hours postoperatively', 'description': 'Patients will be followed up for 24 hours in terms of undesirable side effects, vascular puncture, hematoma, signs of LA toxicity, respiratory distress, pneumothorax, and horner syndrome.'}, {'measure': 'The Rescue Analgesia', 'timeFrame': '24 hours postoperatively', 'description': "As rescue analgesia, Tramadol 1 mg/kg IV will be ordered to be administered when the patient's NRS is 3 or more. The first time when the patient receives rescue analgesia will be recorded."}, {'measure': '24-Hour Total Opioid Consumption', 'timeFrame': '24 hours postoperatively', 'description': 'The total dose of rescue analgesia (Tramadol ) for the first 24 hours will be recorded.'}, {'measure': 'Pain Score Follow-up 6th Hour', 'timeFrame': '6th Hour', 'description': "Pain Score Follow-up; patients' pain scores will be recorded by checking their NRS (Numeric Rating Scale) scores at the 6th hour."}, {'measure': 'Pain Score Follow-up 12th Hour', 'timeFrame': '12th Hour', 'description': "Pain Score Follow-up; patients' pain scores will be recorded by checking their NRS (Numeric Rating Scale) scores at the 12th hour."}, {'measure': 'Pain Score Follow-up 24th Hour', 'timeFrame': '24th Hour', 'description': "Pain Score Follow-up; patients' pain scores will be recorded by checking their NRS (Numeric Rating Scale) scores at the 24th hour."}, {'measure': 'The Motor Block Level 20th minute', 'timeFrame': '20th minute', 'description': 'The motor block will be evaluated with a Modified Bromage Scale. ( 0: No blocks, he can lift his arm; 1: Arm is weak but active; 2: Arm is motionless but fingers are active; 3: Complete block, no movement in hand or arm. )'}, {'measure': 'The Motor Block Level 30th minute', 'timeFrame': '30th minute', 'description': 'The motor block will be evaluated with a Modified Bromage Scale. ( 0: No blocks, he can lift his arm; 1: Arm is weak but active; 2: Arm is motionless but fingers are active; 3: Complete block, no movement in hand or arm. )'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Brachial plexus block', 'Nerve block'], 'conditions': ['Anesthesia Conduction', 'Upper Extremity Surgery', 'Pain, Postoperative', 'Anesthesia and Analgesia', 'Nerve Block', 'Brachial Plexus Block']}, 'referencesModule': {'references': [{'pmid': '23364778', 'type': 'BACKGROUND', 'citation': 'Gurkan Y, Hosten T, Tekin M, Acar S, Solak M, Toker K. [Comparison of ultrasound-guided supraclavicular and infraclavicular approaches for brachial plexus blockade]. Agri. 2012;24(4):159-64. doi: 10.5505/agri.2012.38247. Turkish.'}, {'pmid': '30857608', 'type': 'BACKGROUND', 'citation': 'Grape S, Pawa A, Weber E, Albrecht E. Retroclavicular vs supraclavicular brachial plexus block for distal upper limb surgery: a randomised, controlled, single-blinded trial. Br J Anaesth. 2019 Apr;122(4):518-524. doi: 10.1016/j.bja.2018.12.022. Epub 2019 Jan 31.'}, {'pmid': '16116009', 'type': 'BACKGROUND', 'citation': 'Arcand G, Williams SR, Chouinard P, Boudreault D, Harris P, Ruel M, Girard F. Ultrasound-guided infraclavicular versus supraclavicular block. Anesth Analg. 2005 Sep;101(3):886-890. doi: 10.1213/01.ANE.0000159168.69934.CC.'}]}, 'descriptionModule': {'briefSummary': 'Ultrasound-guided brachial plexus blocks are used successfully for upper extremity surgeries. In this randomized prospective single-blind study, ASA I-II patients aged 18-65 years undergoing hand, wrist, and forearm surgery will be randomly divided into two groups. First group will receive ultrasound-guided coronal oblique supraclavicular block using a 22G, 50 mm stimulator needle, and the second group, ultrasound-guided lateral sagittal infraclavicular block using a 22G 100 mm stimulator needle. We will prepare, 30 ml of 1:1 0.5% bupivacaine and 2% prilocaine with 5 mcg adrenaline per milliliter as local anesthetic mixture. Block application time, block success, sensory and motor block levels, and postoperative analgesia time will be recorded and compared between the groups. Accordingly, the success rate of the two methods will be evaluated.', 'detailedDescription': "In this prospective single-blind study, patients will be divided into 2 groups with the closed envelope method. Patients will be taken to the block application room before the operation. Standard monitoring (pulse oximetry, noninvasive blood pressure, ECG) will be applied to the patients. Premedication will be provided with 1mg IV midazolam after peripheral vascular access. Blocks will be performed by an experienced anesthesiologist under the guidance of USG and evaluated by another anesthesiologist who is blind to the block technique. After the antisepsis of the area, a 22G 100 mm stimulator needle will be used in the infraclavicular approach and a 22G 50 mm in the supraclavicular block. Intermittent negative aspiration will be performed during all procedures to detect possible vascular puncture. 30 ml of 1:1 0.5% bupivacaine and 2% prilocaine plus 5 mcg adrenaline per ml will be used as local anesthetic mixture. The infraclavicular block will be applied by the lateral sagittal method under USG guidance. Supraclavicular block will be applied in the coronal oblique plane while the probe is placed on the clavicle. Following the blocks, the 5th, 10th, 15th, 20th, 25th, and 30th-minute sensory block levels, 10th, 20th, and 30th-minute motor block levels will be recorded. Sensory block level; Axillary, median, radial, ulnar, musculocutaneous, cutaneous brachia, and cutaneous antebrachii medialis nerve level will be evaluated with the pinprick test and its level will be recorded. (0 = painful, no block; 1 = partial block-analgesia, only tactile sensation; 2 = complete block, no pain). The motor block will be evaluated with a modified bromage scale: 0: No blocks, he can lift his arm; 1: Arm is weak but active; 2: Arm is motionless but fingers are active; 3: Complete block, no movement in hand or arm.\n\nBlock success; At the 30th minute of LA application, the pinprick test will define the presence of insensibility or only a sense of touch in the musculocutaneous, radial, ulnar, median, cutaneous antebrachii nerves. If any of these nerves are not blocked, it will be considered a failed block.\n\nPostoperative analgesia time; It will be considered as when the NRS(Numeric Rating Scale) is≥1.\n\nPain Score Follow-up; patients' pain scores will be recorded by checking their NRS scores at the 2nd, 6th, 12th, 24th hours.\n\nSensory (the time from local anesthetic injection until the patient fully perceives the upper limb) and motor (the time from local anesthetic injection until the patient's upper extremity regains full muscle strength) block time will be recorded as the block return time. Pain score during block application will be evaluated with the NRS. Block application time will be defined as the time from the moment the needle passes the skin until the local anesthetic is given and withdrawn. Block formation time will be defined as the time required to initiate anesthesia and analgesia in all 5 distal nerves. Patient and surgeon satisfaction will be evaluated as 1 = complete dissatisfaction, 2 = moderate satisfaction, 3 = full satisfaction, after the procedure. Patients will be followed up for 24 hours in terms of undesirable side effects, vascular puncture, hematoma, signs of LA toxicity, respiratory distress, pneumothorax, and horner syndrome. As rescue anesthesia, sedoanalgesia will be tried with remifentanil infusion, if it is not successful, general anesthesia will be started with a laryngeal mask. As postoperative analgesic regimen, patients will receive 3 x 1000 mg IV acetaminophen. As rescue analgesia, Tramadol 1 mg/kg IV will be ordered to be administered when the patient's NRS is 3 or more. The first time when the patient receives rescue analgesia and the total dose of rescue analgesia for the first 24 hours will be recorded."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-65 years old\n* ASA I-II\n* Patients scheduled for hand, wrist, and forearm surgery\n\nExclusion Criteria:\n\n* Uncoordinated patients\n* Having a disease that prevents sensory block evaluation,\n* Have coagulopathy,\n* Known allergies to drugs to be used,\n* Those with anatomical disorders at the application points\n* Pregnant patients,\n* Patients under 18 years of age,\n* Patients with known local anesthetic allergy,\n* Patients diagnosed with sepsis and bacteriemia,\n* Skin infection at the injection site.'}, 'identificationModule': {'nctId': 'NCT04784104', 'briefTitle': 'Comparison of Infraclavicular And Supraclavicular Block', 'organization': {'class': 'OTHER', 'fullName': 'Bozyaka Training and Research Hospital'}, 'officialTitle': 'Comparison of Infraclavicular and Supraclavicular Block Approaches in Ultrasound Guided Brachial Plexus Block', 'orgStudyIdInfo': {'id': 'SupraInfraTez'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supraclaviculer block', 'description': 'The coronal oblique supraclavicular block will be applied to the first group with ultrasound guidance using a 22G 50 mm stimulator needle. 30 ml of bupivacaine (Bupivacaine HCl %0.5) and prilocaine (Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5 mcg adrenaline per ml. (14 ml. bupivacaine, 14 ml. prilocaine, 2 ml saline with 5 mcg adrenaline per ml.) Intermittent negative aspiration will be performed during all procedures to detect possible vascular puncture.', 'interventionNames': ['Drug: Bupivacaine HCl 0.5% Injectable Solution', 'Drug: Prilocaine HCl 2% Injectable solution', 'Drug: Adrenaline amp. 0.5 mg', 'Procedure: Ultrasound guided supraclavicular block with coronal oblique method']}, {'type': 'EXPERIMENTAL', 'label': 'Infraclaviculer block', 'description': 'The lateral sagittal infraclavicular block will be applied to the second group with ultrasound guidance using a 22G 100 mm stimulator needle. 30 ml of bupivacaine (Bupivacaine HCl %0.5) and prilocaine (Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5 mcg adrenaline per ml. (14 ml. bupivacaine, 14 ml. prilocaine, 2 ml saline with 5 mcg adrenaline per ml.). Intermittent negative aspiration will be performed during all procedures to detect possible vascular puncture.', 'interventionNames': ['Drug: Bupivacaine HCl 0.5% Injectable Solution', 'Drug: Prilocaine HCl 2% Injectable solution', 'Drug: Adrenaline amp. 0.5 mg', 'Procedure: Ultrasound guided lateral sagittal infraclavicular block']}], 'interventions': [{'name': 'Bupivacaine HCl 0.5% Injectable Solution', 'type': 'DRUG', 'otherNames': ['Bupivacaine 0.5%'], 'description': '30 ml of bupivacaine (Bupivacaine HCl %0.5) and prilocaine (Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5 mcg adrenaline per ml. (14 ml. bupivacaine, 14 ml. prilocaine and 2 ml saline with 5 mcg adrenaline per ml.)', 'armGroupLabels': ['Infraclaviculer block', 'Supraclaviculer block']}, {'name': 'Prilocaine HCl 2% Injectable solution', 'type': 'DRUG', 'otherNames': ['Priloc %2'], 'description': '30 ml of bupivacaine (Bupivacaine HCl %0.5) and prilocaine (Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5 mcg adrenaline per ml. (14 ml. bupivacaine, 14 ml. prilocaine and 2 ml saline with 5 mcg adrenaline per ml.)', 'armGroupLabels': ['Infraclaviculer block', 'Supraclaviculer block']}, {'name': 'Adrenaline amp. 0.5 mg', 'type': 'DRUG', 'otherNames': ['Adrenalin codex 0.5 mg 1 ml injectable solution'], 'description': '30 ml of bupivacaine (Bupivacaine HCl %0.5) and prilocaine (Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5 mcg adrenaline per ml. (14 ml. bupivacaine, 14 ml. prilocaine and 2 ml saline with 5 mcg adrenaline per ml.)', 'armGroupLabels': ['Infraclaviculer block', 'Supraclaviculer block']}, {'name': 'Ultrasound guided supraclavicular block with coronal oblique method', 'type': 'PROCEDURE', 'description': 'The blocks will be performed by an experienced anesthesiologist with a USG guidence.', 'armGroupLabels': ['Supraclaviculer block']}, {'name': 'Ultrasound guided lateral sagittal infraclavicular block', 'type': 'PROCEDURE', 'description': 'The blocks will be performed by an experienced anesthesiologist with USG guidence.', 'armGroupLabels': ['Infraclaviculer block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35170', 'city': 'Izmir', 'state': 'Karabağlar', 'country': 'Turkey (Türkiye)', 'facility': 'Izmir Bozyaka Training and Research Hospital', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'centralContacts': [{'name': 'Mehmet E Şen, MD', 'role': 'CONTACT', 'email': 'm_emre_sen@hotmail.com', 'phone': '+905436838272'}, {'name': 'Zeki T Tekgül, Assoc Prof', 'role': 'CONTACT', 'email': 'zekitekgul@yahoo.com', 'phone': '+905058554705'}], 'overallOfficials': [{'name': 'Mehmet E Şen, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Izmir Bozyaka Training and Research Hospital'}, {'name': 'Zeki T Tekgül, Assoc Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Izmir Bozyaka Training and Research Hospital'}, {'name': 'Taşkın Altay, Assoc Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Izmir Bozyaka Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bozyaka Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Anesthesiology Resident', 'investigatorFullName': 'Mehmet Emre Şen', 'investigatorAffiliation': 'Bozyaka Training and Research Hospital'}}}}