Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT06027918
Status:
COMPLETED
Last Update Posted:
2024-05-23
First Post:
2023-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Altitude Difference on the Duration of Nerve Block; A Three-Center Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 159}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-22', 'studyFirstSubmitDate': '2023-08-29', 'studyFirstSubmitQcDate': '2023-09-05', 'lastUpdatePostDateStruct': {'date': '2024-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale (VAS)', 'timeFrame': 'will be evaluated at 0, 4th, 8th, 12th, 14th, 16th, 18th, 24th hours postoperatively', 'description': '* The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."\n* Pain intensity at the site of the operation.'}], 'secondaryOutcomes': [{'measure': 'total amount of intravenous analgesics consumed', 'timeFrame': 'will be evaluated at 0, 4th, 8th, 12th, 14th, 16th, 18th, 24th hours postoperatively', 'description': 'to be evaluated at the end of 24 hours postoperatively'}, {'measure': 'Sensory block start time', 'timeFrame': 'The sensory block will be evaluated approximately 10 minutes after the application. It will be observed up to a maximum of 30 minutes.', 'description': 'The onset time of sensory block was defined as the time to reach an absence of hot-cold sensation in all 4 nerve distributions after completion of injection of the local anesthetic mixture.\n\nSensory block was assessed using the cold test on the dermatomes of the median, ulnar, radial and musculocutaneous nerves. Sensory block was graded on a 3-point scale (0: normal sensation, 1: analgesia \\[patient can feel touch but not cold\\], 2: anesthesia \\[patient cannot even feel touch\\]).'}, {'measure': 'sensory block end time', 'timeFrame': 'It will be evaluated every hour after the implementation, up to a maximum of 120 hours.', 'description': 'Sensory block end time: defined as the time when the hot-cold sensation disappears in all 4 nerve distributions after the injection of the local anesthetic mixture is completed.'}, {'measure': 'Time to onset of motor block', 'timeFrame': 'Motor block onset time will be assessed every 10 minutes after the intervention until 60 minutes.', 'description': 'Time to onset of motor block, the time from the completion of injection of the local anesthetic mixture until complete motor block develops (in case of bromage : 4).\n\nMotor block was assessed with the Modified Bromage scale (scale 0: full flexion of the fingers, wrist and elbow; scale 1: full flexion of the fingers and wrist, but no flexion of the elbow); scale 2: full flexion of the fingers, but no flexion of the wrist and elbow; scale 3: complete motor block; no flexion of the fingers, wrist and elbow).'}, {'measure': 'Motor block end time', 'timeFrame': 'It will be evaluated every hour after the implementation, up to a maximum of 120 hours.', 'description': 'Motor block was assessed with the Modified Bromage scale (scale 0: full flexion of the fingers, wrist and elbow; scale 1: full flexion of the fingers and wrist, but no flexion of the elbow); scale 2: full flexion of the fingers, but no flexion of the wrist and elbow; scale 3: complete motor block; no flexion of the fingers, wrist and elbow).\n\nIf the bromage is 0, the motor block will be considered as eliminated.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Forearm Surgery']}, 'referencesModule': {'references': [{'pmid': '11167511', 'type': 'BACKGROUND', 'citation': 'Harmon D, Frizelle HP. Supraclavicular block for day-case anaesthesia at altitude. Anaesthesia. 2001 Feb;56(2):197. doi: 10.1046/j.1365-2044.2001.01870-30.x. No abstract available.'}]}, 'descriptionModule': {'briefSummary': "Infraclavicular brachial plexus block in hand and forearm surgery has the advantages of high success rate and low risk of complications and is useful in providing long-lasting and effective postoperative analgesia in these patients. In response to hypoxemia at high altitude, increased blood viscosity, decreased carbon monoxide diffusion capacity, increased cerebral arterial blood flow, decreased blood volume and decreased cardiac output occur. At high altitude, the serum level of local anesthetics may increase due to an increase in their ionized fraction and a decrease in their clearance. In this respect, the pharmacodynamic and pharmacokinetic properties of peripheral nerve blocks may be altered when performed at high altitude. The primary objective of this prospective study was to test the hypothesis that postoperative pain scores are higher in patients undergoing infraclavicular nerve block at high altitude than in patients at low altitude.\n\nThis multicenter prospective randomized study will be initiated after approval of the Ethics Committee of Health ScienceUniversity Diyarbakir Gazi Yasargil Training and Research Hospital. Patients will be recruited simultaneously in 3 hospitals, Hatay Training and Research Hospital, Hatay, Turkey (100 m above sea level);Health Science Health Science University Diyarbakir Gazi Yasargil Training and Research Hospital, Diyarbakir, Turkey (675 m above sea level) and Health Science University Van Regional and Training Research Hospital, Van, Turkey (1726 m above sea level).\n\nInfraclavicular brachial plexus blocks (coracoid approach) will be performed by administering a local anesthetic mixture of 1.5 mg/kg lidocaine 2% + 1 mg/kg bupivacaine 0.5% at the 6 o'clock position of the axillary artery under US guidance.", 'detailedDescription': "Group V (1726 meter altitude): In the application of infraclavicular brachial plexus blocks (coracoid approach); 1.5mg/kg dose of bupivacaine and 1mg/kg lidocaine mixture will be applied around the axillary artery in the 6 o'clock position under US guidance.\n\n* The block will be applied only once, approximately 15-20 minutes before surgery.\n* All patients will undergo electrocardiographic monitoring, oxygen saturation monitoring with pulse oximetry and blood pressure measurement with automatic pneumatic manometer before the application.\n* Intravenous 1mg midazolam and 50 mcg fentanyl will be administered to all patients for premedication before the procedure.\n* The amount of medication to be given to all patients will be prepared as 1.5mg/kg bupivacaine and 1mg/kg lidocaine.\n* The prepared drug will be administered around the axillary artery at the appropriate anatomical location determined under ultrasound guidance.\n* Ultrasound device will be used as a supportive device during the application.\n* The application will be performed by an anesthesiologist with at least 5 years of experience.\n* mode of delivery will be provided face to face and individually\n* The administration will be only once, 20-30 minutes before the surgical procedure, with a dose adjustment of 1.5mg/kg bupivacaine and 1mg/kg lidocaine per kilogram of weight.\n* The application will be made in the preoperative preparation room in the operating room of the hospital where the surgery will be performed.\n* The local anesthetic dose to be used in the application will be calculated according to the weight of the patient. local anesthetics will be prepared by another anesthesiologist in the preoperative preparation room just before the application.\n* In the postoperative period, if the pain intensity (VAS) is \\<4, 100 mg paracetamol will be administered intravenously, if VAS = 4, 100 mg tramadol will be administered intravenously\n\nGroup D (675 meter altitude): In the application of infraclavicular brachial plexus blocks (coracoid approach); 1.5 mg/kg dose of bupivacaine and 1mg/kg lidocaine mixture will be applied around the axillary artery in the 6 o'clock position under US guidance.\n\n* The block will be applied only once, approximately 15-20 minutes before surgery.\n* All patients will undergo electrocardiographic monitoring, oxygen saturation monitoring with pulse oximetry and blood pressure measurement with automatic pneumatic manometer before the application.\n* Intravenous 1mg midazolam and 50 mcg fentanyl will be administered to all patients for premedication before the procedure.\n* The amount of medication to be given to all patients will be prepared as 1.5 mg/kg bupivacaine and 1mg/kg lidocaine.\n* The prepared drug will be administered around the axillary artery at the appropriate anatomical location determined under ultrasound guidance.\n* Ultrasound device will be used as a supportive device during the application.\n* The application will be performed by an anesthesiologist with at least 5 years of experience.\n* mode of delivery will be provided face to face and individually\n* The administration will be only once, 20-30 minutes before the surgical procedure, with a dose adjustment of 1.5 mg/kg bupivacaine and 1mg/kg lidocaine per kilogram of weight.\n* The application will be made in the preoperative preparation room in the operating room of the hospital where the surgery will be performed.\n* The local anesthetic dose to be used in the application will be calculated according to the weight of the patient. local anesthetics will be prepared by another anesthesiologist in the preoperative preparation room just before the application.\n* In the postoperative period, if the pain intensity (VAS) is \\<4, 100 mg paracetamol will be administered intravenously, if VAS = 4, 100 mg tramadol will be administered intravenously\n\nComparator / control treatment Group H (100 meter altitude): In the application of infraclavicular brachial plexus blocks (coracoid approach); 1.5 mg/kg dose of bupivacaine and 1mg/kg lidocaine mixture will be applied around the axillary artery in the 6 o'clock position under US guidance.\n\n* The block will be applied only once, approximately 15-20 minutes before surgery.\n* All patients will undergo electrocardiographic monitoring, oxygen saturation monitoring with pulse oximetry and blood pressure measurement with automatic pneumatic manometer before the application.\n* Intravenous 1mg midazolam and 50 mcg fentanyl will be administered to all patients for premedication before the procedure.\n* The amount of medication to be given to all patients will be prepared as 1.5 mg/kg bupivacaine and 1 mg/kg lidocaine.\n* The prepared drug will be administered around the axillary artery at the appropriate anatomical location determined under ultrasound guidance.\n* Ultrasound device will be used as a supportive device during the application.\n* The application will be performed by an anesthesiologist with at least 5 years of experience.\n* mode of delivery will be provided face to face and individually\n* The administration will be only once, 20-30 minutes before the surgical procedure, with a dose adjustment of 1.5 mg/kg bupivacaine and 1mg/kg lidocaine per kilogram of weight.\n* The application will be made in the preoperative preparation room in the operating room of the hospital where the surgery will be performed.\n* The local anesthetic dose to be used in the application will be calculated according to the weight of the patient. local anesthetics will be prepared by another anesthesiologist in the preoperative preparation room just before the application.\n* In the postoperative period, if the pain intensity (VAS) is \\<4, 100 mg paracetamol will be administered intravenously, if VAS = 4, 100 mg tramadol will be administered intravenously"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between 18-55 years old\n* Body mass index between 20 and 25\n* Patients with American Society of Anesthesiologists classification (ASA) physical status I or II\n\nExclusion Criteria:\n\n* Patients aged younger than 18 and older than 55 years\n* American Society of Anesthesiologists classification (ASA) ≥ III\n* Body mass index (BMI) \\>35\n* Known history of allergy to local anesthetics preoperative chronic pain and therefore long-term analgesic use\n* In case of coagulopathy\n* Have a condition that constitutes a contraindication for the application of the block (local infection, sepsis, local anesthetic medicine allergy; severe neurological, muscular or psychiatric disease, coagulation disorders)\n* With marked cognitive impairment\n* Patients who did not want to participate in the study.'}, 'identificationModule': {'nctId': 'NCT06027918', 'briefTitle': 'The Effect of Altitude Difference on the Duration of Nerve Block; A Three-Center Study.', 'organization': {'class': 'OTHER', 'fullName': 'Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital'}, 'officialTitle': 'The Effect of Altitude Difference on the Duration of Infraclavicular Peripheral Block Applied to Patients With Hand and Forearm Fractures; a Three-center Study in Adults at 100, 675, 1726 Meters', 'orgStudyIdInfo': {'id': '12.09.2022/266'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group V (1726 meter altitude)', 'description': "In the application of infraclavicular brachial plexus blocks (coracoid approach); 1.5mg/kg dose of bupivacaine and 1mg/kg lidocaine mixture will be applied around the axillary artery in the 6 o'clock position under US guidance.\n\nThe block will be applied only once, approximately 15-20 minutes before surgery.", 'interventionNames': ['Procedure: Infraclavicular brachial plexus block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group D (675 meter altitude)', 'description': "In the application of infraclavicular brachial plexus blocks (coracoid approach); 1.5mg/kg dose of bupivacaine and 1mg/kg lidocaine mixture will be applied around the axillary artery in the 6 o'clock position under US guidance.\n\nThe block will be applied only once, approximately 15-20 minutes before surgery.", 'interventionNames': ['Procedure: Infraclavicular brachial plexus block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group H( 100 meter altitude)', 'description': "In the application of infraclavicular brachial plexus blocks (coracoid approach); 1.5mg/kg dose of bupivacaine and 1mg/kg lidocaine mixture will be applied around the axillary artery in the 6 o'clock position under US guidance.\n\nThe block will be applied only once, approximately 15-20 minutes before surgery.", 'interventionNames': ['Procedure: Infraclavicular brachial plexus block']}], 'interventions': [{'name': 'Infraclavicular brachial plexus block', 'type': 'PROCEDURE', 'description': "In the application of infraclavicular brachial plexus blocks (coracoid approach); 1.5mg/kg dose of bupivacaine and 1mg/kg lidocaine mixture will be applied around the axillary artery in the 6 o'clock position under US guidance.", 'armGroupLabels': ['Group D (675 meter altitude)', 'Group H( 100 meter altitude)', 'Group V (1726 meter altitude)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21070', 'city': 'Diyarbakır', 'country': 'Turkey (Türkiye)', 'facility': 'Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital', 'geoPoint': {'lat': 37.91363, 'lon': 40.21721}}], 'overallOfficials': [{'name': 'Cem K. Kaçar, Assoc.Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Fatma Acil,MD', 'investigatorAffiliation': 'Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital'}}}}