Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-30 @ 11:50 AM
Study NCT ID:
NCT06906458
Status:
COMPLETED
Last Update Posted:
2025-11-17
First Post:
2025-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Paresthesia on Postoperative Neurological Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D010292', 'term': 'Paresthesia'}], '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': 'D020886', 'term': 'Somatosensory Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-10-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2025-03-25', 'studyFirstSubmitQcDate': '2025-03-31', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Paresthesia incidence', 'timeFrame': 'Perioperative time', 'description': 'Paresthesia is considered an abnormal sensation described as "tingling, pinprick, severe pain, or an electric feeling in the arm." When paresthesia occurs, the block procedure will be halted, and the needle will be redirected; local anesthetic will not be administered until the paresthesia resolves, and the occurrence of paresthesia will be recorded.'}], 'secondaryOutcomes': [{'measure': 'Incidence of postoperative neurological symptoms', 'timeFrame': '30 days', 'description': 'the status of postoperative neurological symptoms will be assessed via telephone by a physician different from the one who performed the block. During the evaluation, symptoms such as arm numbness, tingling, abnormal sensations, pain, and weakness will be considered. Those responding "yes" to any of these symptoms will be classified as patients experiencing postoperative neurological symptoms.'}, {'measure': 'Postoperative pain', 'timeFrame': '36 hours', 'description': 'In the postoperative period, patients will be assessed for pain using a 0-10 Numeric Rating Scale (NRS) at rest at 4, 6, 8, 12, 16, and 18 hours, and at both rest and during movement at 24 and 36 hours to record the highest pain scores. The NRS is a scale used for patients to express their pain levels, where 0 represents the absence of pain and 10 represents the most severe pain.'}, {'measure': 'Duration of block effectiveness', 'timeFrame': '36 hours', 'description': 'The time (in minutes) until the patient reports a significant increase in pain after the block'}, {'measure': 'Postoperative nausea and vomiting', 'timeFrame': '36 hours', 'description': 'Significant nausea, vomiting, and/or need for rescue antiemetics'}, {'measure': 'Rescue analgesic requirement', 'timeFrame': '36 hours', 'description': 'Number of additional analgesic applications'}, {'measure': 'Rescue antiemetic requirement', 'timeFrame': '36 hours', 'description': 'Number of additional antiemetic applications'}, {'measure': 'intraoperative opioid requirement', 'timeFrame': 'intraoperative time', 'description': 'To maintain the bispectral index (BIS) between 40-60, remifentanil will be initiated and titrated between 0.05-0.25 mcg/kg/min, taking into account a 20% increase in MAP (mean arterial pressure) compared to the initial value and a 15% increase in heart rate compared to the initial value.'}, {'measure': 'Duration of stay in the recovery room', 'timeFrame': '2 hours', 'description': 'The time from arrival in the recovery room until the discharge criteria are met'}, {'measure': 'Quality of Recovery-15 (QoR-15) scores', 'timeFrame': '30 days', 'description': 'The QoR-15 questionnaire consists of 15 questions rated on a scale of 0 to 10, with a total score assessed out of 150. Results are classified as follows: above 135 is considered "excellent," 122-135 is "good," 90-121 is "fair," and below 90 is "poor.'}, {'measure': "Horner's syndrome", 'timeFrame': 'Perioperative/Periprocedural', 'description': 'Miosis and ptosis of the ipsilateral pupil during the perioperative period.'}, {'measure': 'Dyspnea', 'timeFrame': 'Perioperative/Periprocedural', 'description': 'Breathing difficulty as described by the patient during the perioperative period.'}, {'measure': 'Hoarseness', 'timeFrame': 'Perioperative/Periprocedural', 'description': 'Voice changes described by the patient during the perioperative period'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Interscalene block', 'Paresthesia', 'Postoperative neurological symptoms'], 'conditions': ['Interscalene Block', 'Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'In this study, the effect of paresthesia occurring during the interscalene block procedure on the incidence of postoperative neurological symptoms will be investigated. Paresthesia is defined as an abnormal sensation described as "tingling, pinprick, severe pain, or an electric feeling in the arm." The status of postoperative neurological symptoms in patients at the end of the block\'s effective duration will be assessed through phone interviews, evaluating symptoms such as arm numbness, tingling, abnormal sensations, pain, and weakness.', 'detailedDescription': "Our study includes patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I or II who undergo interscalene nerve block prior to arthroscopic shoulder surgery under general anesthesia. All patients will be fasting according to standard protocol. During the preoperative period, patients' age, comorbidities, gender, body mass index (BMI), ASA scores, and preoperative Quality of Recovery-15 (QoR-15) scores will be recorded.\n\nIn the operating room, possible complications related to the block (paresthesia, Horner's syndrome, dyspnea, hoarseness) will be monitored in the preoperative area. During the intraoperative period, data such as pulse, blood pressure, infusion fluids, intraoperative remifentanil requirements, anesthesia duration, and surgical time will be recorded.\n\nIn the postoperative period, postoperative pain status, block duration, postoperative nausea and vomiting, need for rescue analgesics and antiemetics, and QoR-15 scores on the first day will be assessed in the recovery room and ward. Additionally, postoperative neurological symptoms and QoR-15 scores will be followed via telephone on the 3rd, 7th, 10th, and 30th days after discharge.\n\nFor patients developing postoperative pain, pain intensity will be evaluated using an 11-point numeric rating scale, where 0 indicates no symptoms and 10 represents maximum severity."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study will include patients aged 18-65 years with ASA physical status I or II who are planned to undergo interscalene nerve block for analgesia prior to arthroscopic shoulder surgery in the beach chair position under general anesthesia.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* ASA physical status I to II\n* Age range of 18-65 years\n* Patients planned for interscalene nerve block for analgesia prior to arthroscopic shoulder surgery in the beach chair position under general anesthesia\n\nExclusion Criteria:\n\n* body mass index \\>35 kg/m²)\n* history of drug use\n* Patient's refusal to participate in the study\n* Psychiatric disorders\n* Central nervous system diseases\n* Vestibular disorders\n* Presence of diabetes, neuropathy, and paralysis\n* Pregnancy\n* Open shoulder surgery\n* Allergy to local anesthetics\n* Coagulopathy\n* Severe thrombocytopenia\n* Infection at the puncture site\n* Pre-existing neuropathy in the limb to be operated on\n* Use of opioid and antiemetic medications before surgery\n* Use of dexamethasone\n* Lung disease\n* Low baseline oxygen saturation\n* Patients who cannot cooperate in the postoperative period (e.g., mental retardation, delirium, language acquisition deficiency, etc.)"}, 'identificationModule': {'nctId': 'NCT06906458', 'briefTitle': 'Impact of Paresthesia on Postoperative Neurological Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'Effect of Paresthesia During Interscalene Block Procedure on the Incidence of Postoperative Neurological Symptoms: A Prospective Observational Clinical Study', 'orgStudyIdInfo': {'id': 'Paresthesia'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Paresthesia', 'description': 'Patients experiencing paresthesia during the interscalene nerve block', 'interventionNames': ['Other: Paresthesia']}, {'label': 'No paresthesia', 'description': 'Patients not experiencing paresthesia during the interscalene nerve block', 'interventionNames': ['Other: No paresthesia']}], 'interventions': [{'name': 'Paresthesia', 'type': 'OTHER', 'description': 'Patients experiencing paresthesia during the interscalene nerve block', 'armGroupLabels': ['Paresthesia']}, {'name': 'No paresthesia', 'type': 'OTHER', 'description': 'Patients not experiencing paresthesia during the interscalene nerve block', 'armGroupLabels': ['No paresthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06800', 'city': 'Ankara', 'state': 'Ankara, Çankaya', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara Bilkent City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesiology and Reanimation specialist doctor', 'investigatorFullName': 'Gökhan Erdem', 'investigatorAffiliation': 'Ankara City Hospital Bilkent'}}}}