Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-03-01 @ 12:19 AM
Study NCT ID:
NCT03190551
Status:
COMPLETED
Last Update Posted:
2017-06-19
First Post:
2017-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retroclavicular Versus Costoclavicular Approach for Infraclavicular Brachial Plexus Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-15', 'studyFirstSubmitDate': '2017-06-12', 'studyFirstSubmitQcDate': '2017-06-15', 'lastUpdatePostDateStruct': {'date': '2017-06-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Needle shaft visibility', 'timeFrame': '10 minutes after the needle inserted the skin', 'description': 'Needle visibility reviewed by two anesthesiologists using a 5-point Likert scale'}], 'secondaryOutcomes': [{'measure': 'Technique duration', 'timeFrame': 'Time required in seconds for the block completion (10 minutes)', 'description': 'Number of seconds needed to complete the block, from time of local skin anesthesia until regional block needle removal.'}, {'measure': 'Patient satisfaction using a visual analogue scale', 'timeFrame': 'Assessed 24 hours after the block', 'description': 'Using a visual analog scala, patients will quantify their satisfaction with the retroclavicular and costaclavicular technique .'}, {'measure': 'supplemental analgesic used', 'timeFrame': '90 minutes after block completion', 'description': 'The use of supplementary local anesthetic and the use of intravenous narcotics were recorded.'}, {'measure': 'complications such as pneumothorax, hemothorax, intraarterial injection, intravenous injection', 'timeFrame': '24 hours', 'description': 'Asked about possible complications'}, {'measure': 'motor block success rate', 'timeFrame': 'Assessed 40 minutes after block completion', 'description': 'Success is defined as complete motor block in the distribution of the radial, median, ulnar, musculocutaneous nerves of the forearm and hand'}, {'measure': 'Success Rate of the sensorial Block', 'timeFrame': 'Assessed 30 minutes after block completion', 'description': 'Success is defined as complete sensory loss in the distribution of the radial, median, ulnar, musculocutaneous, and medial cutaneous nerves of the forearm and hand'}, {'measure': 'Block performance related pain', 'timeFrame': '10 minutes after the needle inserted the skin', 'description': 'Block performance related pain was evaluated with a visual analog scala after the removal of the needle.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['infraclavicular brachial plexus block', 'retroclavicular approach', 'costoclavicular approach', 'upper limb surgery', 'needle shaft visibility'], 'conditions': ['Disorder of Upper Extremity']}, 'descriptionModule': {'briefSummary': 'The primary aim of this study is to compare needle shaft visibility between the retroclavicular approach and costoclavicular approach for infraclavicular brachial plexus block in patients undergoing elective upper limb surgery. Secondary aim is to investigate the differences between the two groups in sensorial block success rate, block performance time, block performance related pain, motor block success rate, surgical success rate, complications, patient satisfaction, use of supplemental local anesthetic, use of analgesic.', 'detailedDescription': "Infraclavicular blocks are performed with different approaches. This study evaluated the effectiveness, safety and feasibility of a retroclavicular brachial plexus block as compared with costoclavicular approach for infraclavicular brachial plexus block. 60 patients scheduled for elective upper limb surgery were recruited and randomized into two groups: Retroclavicular approach for infraclavicular block (Group I), costoclavicular approach for infraclavicular block (Group R). Sensory block, adverse effects and complications were evaluated and recorded every 5 minutes until 30 min after local anesthetic injection. Success rate of each nerve sensory block, complications, rate of satisfaction, rate of failure and incidence rate of adverse effects, the needle shaft visibility, procedure time,duration of the block's effect, use of supplemental local anesthetic, use of analgesic are compared with both groups."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who undergo elective forearm or hand surgery under infraclavicular brachial plexus block\n* American Society of Anesthesiologists class 1 to 3\n* Ability to consent\n\nExclusion Criteria:\n\n* History of allergic reaction to local anaesthetics\n* Peripheral neuropathy\n* Renal or hepatic insufficiency\n* Coagulation disorders'}, 'identificationModule': {'nctId': 'NCT03190551', 'briefTitle': 'Retroclavicular Versus Costoclavicular Approach for Infraclavicular Brachial Plexus Block', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Antalya Training and Research Hospital'}, 'officialTitle': 'A Randomized Controlled Trial Comparing Retroclavicular and Costoclavicular Approach for Infraclavicular Brachial Plexus Block', 'orgStudyIdInfo': {'id': 'AntalyaTRH15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'retroclavicular approach', 'description': 'Patients in this group will be randomized to receive an retroclavicular approach to Ultrasound Guided Infraclavicular Brachial Plexus Nerve Block .', 'interventionNames': ['Other: retroclavicular approach']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'costoclavicular approach', 'description': 'Patients in this group will be randomized to receive an costoclavicular approach to Ultrasound Guided Infraclavicular Brachial Plexus Nerve Block .', 'interventionNames': ['Other: costoclavicular approach']}], 'interventions': [{'name': 'retroclavicular approach', 'type': 'OTHER', 'description': 'Retroclavicular approach for ultrasound guided infraclavicular brachial plexus block', 'armGroupLabels': ['retroclavicular approach']}, {'name': 'costoclavicular approach', 'type': 'OTHER', 'description': 'costoclavicular approach for ultrasound guided infraclavicular brachial plexus block', 'armGroupLabels': ['costoclavicular approach']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07100', 'city': 'Antalya', 'country': 'Turkey (Türkiye)', 'facility': 'Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation', 'geoPoint': {'lat': 36.90812, 'lon': 30.69556}}], 'overallOfficials': [{'name': 'Hayri Fatih Metinyurt, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Antalya Training and Research Hospital'}, {'name': 'Nilgun Kavrut Ozturk, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Antalya Training and Research Hospital'}, {'name': 'Ali Sait Kavakli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Antalya Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Antalya Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}