TemperamentNCT07450768
How Personality Type Affects Pain and the Need for General Anesthesia in Patients Receiving an Arm Nerve Block for Wrist Fracture Surgery
An observational study of Temperament and Trauma (Including Fractures), run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial summary
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. We studied patients who underwent wrist or upper arm surgery using an axillary nerve block (a type of regional anesthesia that numbs the arm). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Temperament, Trauma (Including Fractures)
- Type of treatment
- Injection or infusion
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2023to 15 Mar 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Age between 18 and 65 years
- Scheduled for elective upper extremity surgery requiring axillary brachial plexus block
- American Society of Anesthesiologists (ASA) physical status I-III
- Ability to understand and complete the TEMPS-A questionnaire
- Provision of written informed consent
Who cannot join
- Refusal to participate
- Contraindication to regional anesthesia (e.g., local infection at injection site, coagulopathy)
- Known allergy to local anesthetics (bupivacaine)
- Cognitive impairment or inability to complete the temperament questionnaire
- Severe psychiatric disorder requiring active treatment
- Incomplete perioperative data or missing VAS assessments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Affective Temperament on Block Success and Hemodynamics in Patients Undergoing Axillary Plexus Block for Distal Radius Fracture: A Prospective Observational Study.
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.
We 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.
Read more
We 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.
These 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.
This research supports a more personalized approach to anesthesia care, taking into account not only physical health but also psychological factors.
Read the detailed description
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.
Affective 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.
All 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.
Hemodynamic 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.
Statistical 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.
This 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.
- Conditions
- Temperament, Trauma (Including Fractures)
- Keywords
- affective temperament, TEMPS-A, Axillary brachial plexus block, Conversion to general anesthesia, Postoperative pain
- Medical subject headings
- Wounds and Injuries, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Depressive Temperament Group | Patients classified as having a depressive affective temperament based on TEMPS-A questionnaire scoring. Procedure: Axillary Brachial Plexus Block Ultrasound-guided axillary brachial plexus block performed using 20 mL of 0.25% bupivacaine for surgical anesthesia of the upper extremity. Drug: Intravenous Sedation Supplemental intravenous sedation administered intraoperatively in cases of patient discomfort during regional anesthesia. Sedation was provided according to standard institutional practice. Procedure: General Anesthesia (if required) Conversion 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. | |
| Anxious Temperament Group | Patients classified as having an anxious affective temperament according to TEMPS-A assessment. Procedure: Axillary Brachial Plexus Block Ultrasound-guided axillary brachial plexus block performed using 20 mL of 0.25% bupivacaine for surgical anesthesia of the upper extremity. Drug: Intravenous Sedation Supplemental intravenous sedation administered intraoperatively in cases of patient discomfort during regional anesthesia. Sedation was provided according to standard institutional practice. Procedure: General Anesthesia (if required) Conversion 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. | |
| Cyclothymic Temperament Group | Patients identified with cyclothymic temperament characteristics using TEMPS-A. Procedure: Axillary Brachial Plexus Block Ultrasound-guided axillary brachial plexus block performed using 20 mL of 0.25% bupivacaine for surgical anesthesia of the upper extremity. Drug: Intravenous Sedation Supplemental intravenous sedation administered intraoperatively in cases of patient discomfort during regional anesthesia. Sedation was provided according to standard institutional practice. Procedure: General Anesthesia (if required) Conversion 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. | |
| Hyperthymic Temperament Group | Patients classified as hyperthymic temperament type based on questionnaire results. Procedure: Axillary Brachial Plexus Block Ultrasound-guided axillary brachial plexus block performed using 20 mL of 0.25% bupivacaine for surgical anesthesia of the upper extremity. Drug: Intravenous Sedation Supplemental intravenous sedation administered intraoperatively in cases of patient discomfort during regional anesthesia. Sedation was provided according to standard institutional practice. Procedure: General Anesthesia (if required) Conversion 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. | |
| Irritable Temperament Group | Patients identified as having irritable temperament features according to TEMPS-A scoring. Procedure: Axillary Brachial Plexus Block Ultrasound-guided axillary brachial plexus block performed using 20 mL of 0.25% bupivacaine for surgical anesthesia of the upper extremity. Drug: Intravenous Sedation Supplemental intravenous sedation administered intraoperatively in cases of patient discomfort during regional anesthesia. Sedation was provided according to standard institutional practice. Procedure: General Anesthesia (if required) Conversion 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. | |
| Non-Dominant Temperament Group | Patients who did not demonstrate dominance in any of the five primary temperament categories. Procedure: Axillary Brachial Plexus Block Ultrasound-guided axillary brachial plexus block performed using 20 mL of 0.25% bupivacaine for surgical anesthesia of the upper extremity. Drug: Intravenous Sedation Supplemental intravenous sedation administered intraoperatively in cases of patient discomfort during regional anesthesia. Sedation was provided according to standard institutional practice. Procedure: General Anesthesia (if required) Conversion 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anesthesia Escalation (Sedation and/or General Anesthesia)
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.
Measured: Intraoperative period (from block performance until completion of surgery)
Secondary outcomes (2)
Postoperative Pain Intensity (VAS Score)
Pain intensity measured using the Visual Analog Scale (0-10), where 0 represents no pain and 10 represents worst imaginable pain.
Measured: Preoperative baseline, postoperative 3rd hour, 12th hour, and 24th hour
Predictors of Anesthesia Escalation
Identification of independent predictors of conversion to general anesthesia using Ridge logistic regression analysis.
Measured: Intraoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start15 Mar 2023
- Primary completion15 Mar 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TemperamentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Nur Arslan, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07450768
- Sponsor's protocol ID
- 2022-21/189
- Status last verified
- Mar 2026
- First submitted
- 1 Mar 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Affective Temperament on Block Success and Hemodynamics in Patients Undergoing Axillary Plexus Block for Distal Radius Fracture: A Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT07450768
- Acronym / sponsor ID
- 2022-21/189
- Conditions
- Temperament, Trauma (Including Fractures)
- Keywords
- affective temperament, TEMPS-A, Axillary brachial plexus block, Conversion to general anesthesia, Postoperative pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
We 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.
We 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.
These 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.
This research supports a more personalized approach to anesthesia care, taking into account not only physical health but also psychological factors.
Detailed description
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.
Affective 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.
All 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.
Hemodynamic 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.
Statistical 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.
This 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Depressive Temperament Group | – | –Patients classified as having a depressive affective temperament based on TEMPS-A questionnaire scoring. Procedure: Axillary Brachial Plexus Block Ultrasound-guided axillary brachial plexus block performed using 20 mL of 0.25% bupivacaine for surgical anesthesia of the upper extremity. Drug: Intravenous Sedation Supplemental intravenous sedation administered intraoperatively in cases of patient discomfort during regional anesthesia. Sedation was provided according to standard institutional practice. Procedure: General Anesthesia (if required) Conversion 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. |
| Anxious Temperament Group | – | –Patients classified as having an anxious affective temperament according to TEMPS-A assessment. Procedure: Axillary Brachial Plexus Block Ultrasound-guided axillary brachial plexus block performed using 20 mL of 0.25% bupivacaine for surgical anesthesia of the upper extremity. Drug: Intravenous Sedation Supplemental intravenous sedation administered intraoperatively in cases of patient discomfort during regional anesthesia. Sedation was provided according to standard institutional practice. Procedure: General Anesthesia (if required) Conversion 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. |
| Cyclothymic Temperament Group | – | –Patients identified with cyclothymic temperament characteristics using TEMPS-A. Procedure: Axillary Brachial Plexus Block Ultrasound-guided axillary brachial plexus block performed using 20 mL of 0.25% bupivacaine for surgical anesthesia of the upper extremity. Drug: Intravenous Sedation Supplemental intravenous sedation administered intraoperatively in cases of patient discomfort during regional anesthesia. Sedation was provided according to standard institutional practice. Procedure: General Anesthesia (if required) Conversion 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. |
| Hyperthymic Temperament Group | – | –Patients classified as hyperthymic temperament type based on questionnaire results. Procedure: Axillary Brachial Plexus Block Ultrasound-guided axillary brachial plexus block performed using 20 mL of 0.25% bupivacaine for surgical anesthesia of the upper extremity. Drug: Intravenous Sedation Supplemental intravenous sedation administered intraoperatively in cases of patient discomfort during regional anesthesia. Sedation was provided according to standard institutional practice. Procedure: General Anesthesia (if required) Conversion 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. |
| Irritable Temperament Group | – | –Patients identified as having irritable temperament features according to TEMPS-A scoring. Procedure: Axillary Brachial Plexus Block Ultrasound-guided axillary brachial plexus block performed using 20 mL of 0.25% bupivacaine for surgical anesthesia of the upper extremity. Drug: Intravenous Sedation Supplemental intravenous sedation administered intraoperatively in cases of patient discomfort during regional anesthesia. Sedation was provided according to standard institutional practice. Procedure: General Anesthesia (if required) Conversion 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. |
| Non-Dominant Temperament Group | – | –Patients who did not demonstrate dominance in any of the five primary temperament categories. Procedure: Axillary Brachial Plexus Block Ultrasound-guided axillary brachial plexus block performed using 20 mL of 0.25% bupivacaine for surgical anesthesia of the upper extremity. Drug: Intravenous Sedation Supplemental intravenous sedation administered intraoperatively in cases of patient discomfort during regional anesthesia. Sedation was provided according to standard institutional practice. Procedure: General Anesthesia (if required) Conversion 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- Age between 18 and 65 years
- Scheduled for elective upper extremity surgery requiring axillary brachial plexus block
- American Society of Anesthesiologists (ASA) physical status I-III
- Ability to understand and complete the TEMPS-A questionnaire
- Provision of written informed consent
Key exclusion criteria (6 listed)
- Refusal to participate
- Contraindication to regional anesthesia (e.g., local infection at injection site, coagulopathy)
- Known allergy to local anesthetics (bupivacaine)
- Cognitive impairment or inability to complete the temperament questionnaire
- Severe psychiatric disorder requiring active treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anesthesia Escalation (Sedation and/or General Anesthesia)
Time frame: Intraoperative period (from block performance until completion of surgery)
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.
2 secondary outcomes
Postoperative Pain Intensity (VAS Score)
Time frame: Preoperative baseline, postoperative 3rd hour, 12th hour, and 24th hour
Predictors of Anesthesia Escalation
Time frame: Intraoperative period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Temperament and Trauma (Including Fractures), run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anesthesia Escalation (Sedation and/or General Anesthesia) (time frame: Intraoperative period (from block performance until completion of surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.