Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 8:58 PM
Study NCT ID:
NCT07450768
Status:
COMPLETED
Last Update Posted:
2026-03-05
First Post:
2026-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
How Personality Type Affects Pain and the Need for General Anesthesia in Patients Receiving an Arm Nerve Block for Wrist Fracture Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-01', 'studyFirstSubmitDate': '2026-03-01', 'studyFirstSubmitQcDate': '2026-03-01', 'lastUpdatePostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anesthesia Escalation (Sedation and/or General Anesthesia)', 'timeFrame': 'Intraoperative period (from block performance until completion of surgery)', 'description': 'Proportion of patients who required escalation beyond axillary brachial plexus block, defined as the need for additional intravenous sedation and/or conversion to general anesthesia due to inadequate surgical anesthesia or patient discomfort.'}], 'secondaryOutcomes': [{'measure': 'Postoperative Pain Intensity (VAS Score)', 'timeFrame': 'Preoperative baseline, postoperative 3rd hour, 12th hour, and 24th hour', 'description': 'Pain intensity measured using the Visual Analog Scale (0-10), where 0 represents no pain and 10 represents worst imaginable pain.'}, {'measure': 'Predictors of Anesthesia Escalation', 'timeFrame': 'Intraoperative period', 'description': 'Identification of independent predictors of conversion to general anesthesia using Ridge logistic regression analysis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['affective temperament', 'TEMPS-A', 'Axillary brachial plexus block', 'Conversion to general anesthesia', 'Postoperative pain'], 'conditions': ['Temperament', 'Trauma (Including Fractures)']}, 'descriptionModule': {'briefSummary': "This study looked at whether a person's emotional personality type affects how they experience pain and how well a regional anesthesia technique works during arm surgery.\n\nWe studied patients who underwent wrist or upper arm surgery using an axillary nerve block (a type of regional anesthesia that numbs the arm). Before surgery, patients completed a questionnaire measuring their emotional temperament, including anxious, depressive, cyclothymic, irritable, and other personality traits.\n\nWe found that patients with an anxious personality type were more likely to need conversion to general anesthesia during surgery. They also reported higher pain scores after surgery. Patients with depressive traits also experienced higher pain levels. In contrast, some other temperament types reported lower pain levels.\n\nThese findings suggest that emotional characteristics may influence how patients respond to anesthesia and pain after surgery. Understanding a patient's temperament before surgery may help doctors better plan anesthesia, provide additional support when needed, and improve overall comfort and safety.\n\nThis research supports a more personalized approach to anesthesia care, taking into account not only physical health but also psychological factors.", 'detailedDescription': "This prospective observational study evaluates the association between affective temperament profiles and perioperative anesthetic outcomes in adult patients undergoing elective upper extremity surgery under ultrasound-guided axillary brachial plexus block.\n\nAffective temperament was assessed preoperatively using the validated TEMPS-A (Temperament Evaluation of Memphis, Pisa, Paris, and San Diego - Autoquestionnaire). Based on established scoring methodology, participants were categorized into depressive, anxious, cyclothymic, hyperthymic, irritable, or non-dominant temperament types. The instrument is grounded in Akiskal's affective temperament model, which conceptualizes temperament as a stable trait influencing stress reactivity, emotional processing, and physiological responses.\n\nAll patients received a standardized anesthetic protocol. Ultrasound-guided axillary brachial plexus block was performed with identification of the radial, median, ulnar, and musculocutaneous nerves. A total of 20 mL of 0.25% bupivacaine was administered. Intravenous fentanyl (50 µg) was given prior to block placement. Intraoperative discomfort was managed with supplemental sedation. Conversion to general anesthesia was performed when regional anesthesia alone was insufficient to maintain surgical conditions. Block failure was defined as inability to complete the procedure using the regional technique alone.\n\nHemodynamic parameters (systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate) were recorded at baseline and at 5-minute intervals during surgery. Postoperative pain intensity was measured using the Visual Analog Scale at predefined perioperative time points.\n\nStatistical analyses included correlation testing and multivariable modeling. LASSO regression was applied for variable selection and identification of predictors of increased postoperative pain scores. Ridge logistic regression was used to determine independent predictors of anesthesia escalation, accounting for multicollinearity among baseline hemodynamic variables and temperament types.\n\nThis study explores whether stable affective traits influence regional anesthesia adequacy, intraoperative physiological responses, and postoperative pain perception, with the aim of informing individualized perioperative management strategies."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of adult patients undergoing elective upper extremity surgery at Kırşehir Ahi Evran University Training and Research Hospital, a tertiary academic medical center in Turkey. Participants were recruited from patients evaluated in the preoperative anesthesia outpatient clinic and scheduled to receive ultrasound-guided axillary brachial plexus block as the primary anesthetic technique.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 65 years\n* Scheduled for elective upper extremity surgery requiring axillary brachial plexus block\n* American Society of Anesthesiologists (ASA) physical status I-III\n* Ability to understand and complete the TEMPS-A questionnaire\n* Provision of written informed consent\n\nExclusion Criteria:\n\n* Refusal to participate\n* Contraindication to regional anesthesia (e.g., local infection at injection site, coagulopathy)\n* Known allergy to local anesthetics (bupivacaine)\n* Cognitive impairment or inability to complete the temperament questionnaire\n* Severe psychiatric disorder requiring active treatment\n* Incomplete perioperative data or missing VAS assessments'}, 'identificationModule': {'nctId': 'NCT07450768', 'briefTitle': 'How Personality Type Affects Pain and the Need for General Anesthesia in Patients Receiving an Arm Nerve Block for Wrist Fracture Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Kirsehir Ahi Evran Universitesi'}, 'officialTitle': 'The Effect of Affective Temperament on Block Success and Hemodynamics in Patients Undergoing Axillary Plexus Block for Distal Radius Fracture: A Prospective Observational Study.', 'orgStudyIdInfo': {'id': '2022-21/189'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Depressive Temperament Group', 'description': 'Patients classified as having a depressive affective temperament based on TEMPS-A questionnaire scoring.\n\nProcedure: Axillary Brachial Plexus Block\n\nUltrasound-guided axillary brachial plexus block performed using 20 mL of 0.25% bupivacaine for surgical anesthesia of the upper extremity.\n\nDrug: Intravenous Sedation\n\nSupplemental intravenous sedation administered intraoperatively in cases of patient discomfort during regional anesthesia. Sedation was provided according to standard institutional practice.\n\nProcedure: General Anesthesia (if required)\n\nConversion to general anesthesia when regional anesthesia with or without sedation was insufficient to maintain adequate surgical conditions. Block failure was defined as inability to complete the procedure under regional anesthesia alone.'}, {'label': 'Anxious Temperament Group', 'description': 'Patients classified as having an anxious affective temperament according to TEMPS-A assessment.\n\nProcedure: Axillary Brachial Plexus Block\n\nUltrasound-guided axillary brachial plexus block performed using 20 mL of 0.25% bupivacaine for surgical anesthesia of the upper extremity.\n\nDrug: Intravenous Sedation\n\nSupplemental intravenous sedation administered intraoperatively in cases of patient discomfort during regional anesthesia. Sedation was provided according to standard institutional practice.\n\nProcedure: General Anesthesia (if required)\n\nConversion to general anesthesia when regional anesthesia with or without sedation was insufficient to maintain adequate surgical conditions. Block failure was defined as inability to complete the procedure under regional anesthesia alone.'}, {'label': 'Cyclothymic Temperament Group', 'description': 'Patients identified with cyclothymic temperament characteristics using TEMPS-A.\n\nProcedure: Axillary Brachial Plexus Block\n\nUltrasound-guided axillary brachial plexus block performed using 20 mL of 0.25% bupivacaine for surgical anesthesia of the upper extremity.\n\nDrug: Intravenous Sedation\n\nSupplemental intravenous sedation administered intraoperatively in cases of patient discomfort during regional anesthesia. Sedation was provided according to standard institutional practice.\n\nProcedure: General Anesthesia (if required)\n\nConversion to general anesthesia when regional anesthesia with or without sedation was insufficient to maintain adequate surgical conditions. Block failure was defined as inability to complete the procedure under regional anesthesia alone.'}, {'label': 'Hyperthymic Temperament Group', 'description': 'Patients classified as hyperthymic temperament type based on questionnaire results.\n\nProcedure: Axillary Brachial Plexus Block\n\nUltrasound-guided axillary brachial plexus block performed using 20 mL of 0.25% bupivacaine for surgical anesthesia of the upper extremity.\n\nDrug: Intravenous Sedation\n\nSupplemental intravenous sedation administered intraoperatively in cases of patient discomfort during regional anesthesia. Sedation was provided according to standard institutional practice.\n\nProcedure: General Anesthesia (if required)\n\nConversion to general anesthesia when regional anesthesia with or without sedation was insufficient to maintain adequate surgical conditions. Block failure was defined as inability to complete the procedure under regional anesthesia alone.'}, {'label': 'Irritable Temperament Group', 'description': 'Patients identified as having irritable temperament features according to TEMPS-A scoring.\n\nProcedure: Axillary Brachial Plexus Block\n\nUltrasound-guided axillary brachial plexus block performed using 20 mL of 0.25% bupivacaine for surgical anesthesia of the upper extremity.\n\nDrug: Intravenous Sedation\n\nSupplemental intravenous sedation administered intraoperatively in cases of patient discomfort during regional anesthesia. Sedation was provided according to standard institutional practice.\n\nProcedure: General Anesthesia (if required)\n\nConversion to general anesthesia when regional anesthesia with or without sedation was insufficient to maintain adequate surgical conditions. Block failure was defined as inability to complete the procedure under regional anesthesia alone.'}, {'label': 'Non-Dominant Temperament Group', 'description': 'Patients who did not demonstrate dominance in any of the five primary temperament categories.\n\nProcedure: Axillary Brachial Plexus Block\n\nUltrasound-guided axillary brachial plexus block performed using 20 mL of 0.25% bupivacaine for surgical anesthesia of the upper extremity.\n\nDrug: Intravenous Sedation\n\nSupplemental intravenous sedation administered intraoperatively in cases of patient discomfort during regional anesthesia. Sedation was provided according to standard institutional practice.\n\nProcedure: General Anesthesia (if required)\n\nConversion to general anesthesia when regional anesthesia with or without sedation was insufficient to maintain adequate surgical conditions. Block failure was defined as inability to complete the procedure under regional anesthesia alone.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40100', 'city': 'Kırşehir', 'country': 'Turkey (Türkiye)', 'facility': 'Ahi Evran University', 'geoPoint': {'lat': 39.14583, 'lon': 34.16389}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be made publicly available. De-identified data may be made available from the corresponding author upon reasonable request, subject to institutional and ethical approval.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kirsehir Ahi Evran Universitesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asssistant Professor', 'investigatorFullName': 'Fatma Nur Arslan', 'investigatorAffiliation': 'Kirsehir Ahi Evran Universitesi'}}}}