Regional AnesthesiaNCT05678777
Use of Galvanic Skin Response to Measure Peripheral Block Activity
An observational study of Regional Anesthesia, run by Adiyaman University at 1 site in Turkey (Türkiye).
Trial summary
the investigators aim in this study is to determine whether the block is successful in successful infraclavicular brachial plexus blocks performed with USG, according to the change in GSR value in the upper extremity blocked due to sympathetic nerve blockade. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Regional Anesthesia
- What is being tested?
- Galvanic Skin Response
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jan 2022to 30 Mar 2023
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients aged 18-65 who will undergo upper extremity surgery
Who may be able to join
- ASA1-ASA2 patients
- Patients between the ages of 18-65
- Patients who underwent infraclavicular block
Who cannot join
- ASA3-ASA4 patients
- Patients younger than 18 years old and over 65 years old
- Patients who do not want to be included in the study
- Patients in whom infraclavicular brachial plexus block is contraindicated
- Patients who cannot cooperate
- Those with diabetes mellitus
- Patients who have failed infraclavicular brachial plexus block and switched to general anesthesia
- Those with peripheral artery disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Adiyaman University
Adıyaman, 32000
Öznur Uludağ, head of department, 05052309730 ext. 04162231690, uludagoznur@gmail.com
About this study
Official title: Use of Galvanic Skin Response(GSR) to Measure Peripheral Block Activity
the investigators aim in this study is to determine whether the block is successful in successful infraclavicular brachial plexus blocks performed with USG, according to the change in GSR value in the upper extremity blocked due to sympathetic nerve blockade. Block success will be evaluated by sensory and motor examination of the blocked arm.
Read the detailed description
Peripheral nerve block is one of the commonly used blocks in regional anesthesia. In regional anesthesia applications, there are important advantages such as being conscious of the patient, expressing his complaints, continuation of spontaneous breathing, preservation of airway reflexes, continuation of analgesia in the postoperative period and early mobilization of the patient.
In 1978, ultrasound (USG) was used for the first time in peripheral nerve block. With USG, it is possible to monitor the nerves and anatomical structures, follow the needle, and reduce the dose by monitoring the distribution of the local anesthetic administered. Therefore, USG-guided peripheral nerve blocks are frequently used in anesthesia practice.
The Galvanic Skin Response (GSR) is a simple way to obtain autonomic nervous system dependent sweat gland function as a parameter.
Physically, the galvanic skin response is the change in the electrical structure of the skin to various stimuli. Changes in tension measured from the skin surface are recorded. The galvanic skin response is a useful, simple and reproducible electrophysiological technique for investigating sympathetic nervous system function.
The relaxation, calming response that accompanies an increase in skin resistance (causing a decrease in GSR meter) is the body's combat response that accompanies a decrease in skin resistance (causing an increase in GSR meter). Generally, low conductivity is a sign of relaxation. High conductivity is a sign of emotional, mental, or physical arousal. The galvanic skin response is a simple way to obtain autonomic nervous system-related sweat gland function as a parameter.
the investigators aim in this study is to determine whether the block is successful in successful infraclavicular brachial plexus blocks performed with USG, according to the change in GSR value in the upper extremity blocked due to sympathetic nerve blockade. Block success will be evaluated by sensory and motor examination of the blocked arm. The relaxation, calming response that accompanies an increase in skin resistance (causing a decrease in GSR meter) is the body's combat response that accompanies a decrease in skin resistance (causing an increase in GSR meter). Generally, low conductivity is a sign of relaxation. High conductivity is a sign of emotional, mental, or physical arousal.
In the investigators clinic, peripheral nerve blocks accompanied by USG are frequently used in anesthesia practice.
OBJECTİVE: Successful peripheral nerve blockade results in local vasodilation, increased local blood flow, and some increase in skin temperature due to sympathetic fiber blocking. However, in busy operating room conditions, these clinical signs may not appear quickly enough to confirm block adequacy, especially before or during surgery, and may not be used for clinical decision making. Traditional methods for assessing block success are time consuming and require patient cooperation. For the success of the block, it is aimed to use the Galvanic Skin Response (GSR) value, which is a non-invasive method that does not require patient cooperation and provides rapid evaluation.
Galvanic Skin Response (GSR) measurement is a non-invasive and rapid assessment that allows us to observe the skin resistance change with two probes attached to the fingertip. In the investigators study, we aimed to show that the Galvanic Skin Response (GSR) measurement method is a reliable and objective method to evaluate the adequacy of peripheral nerve blocks.
METHODS: This research; It is a prospective observational study. In patients who have performed infraclavicular brachial plexus block; The correlation of Galvanic skin response (GSR) values measured with the finger probe that we attached to the patient's two fingers before and after the block, with the success of the block will be examined. the investigators study is not invasive, it is only in the form of examining finger probe measurements and will not create an additional cost for the investigators hospital and the participants..
- Conditions
- Regional Anesthesia
- Being tested
- Galvanic Skin Response
- Keywords
- Galvanic Skin Response, Peripheral Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Galvanic Skin ResponseDevice
The probe will be attached to the patient's finger and the Galvanic Skin Response will be measured
What is being measured
The primary outcome is the main question the study is designed to answer.
Galvanic Skin Response
Measured: 30/01/2023-28/02/2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start30 Jan 2022
- Primary completion28 Feb 2023 (estimated)
- Study completion30 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Regional AnesthesiaStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adiyaman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fikret Ozerdem, Adiyaman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05678777
- Sponsor's protocol ID
- 18/01/2022-2022/1-10
- Other IDs
- Fadime Tosun
- Status last verified
- Jan 2023
- First submitted
- 2 Jan 2023
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: ı am undecided about sharing individual participant data with other researchers
Publications
Tarvainen MP, Koistinen AS, Valkonen-Korhonen M, Partanen J, Karjalainen PA. Analysis of galvanic skin responses with principal components and clustering techniques. IEEE Trans Biomed Eng. 2001 Oct;48(10):1071-9. doi: 10.1109/10.951509.
PubMed 11585030Marhofer P, Greher M, Kapral S. Ultrasound guidance in regional anaesthesia. Br J Anaesth. 2005 Jan;94(1):7-17. doi: 10.1093/bja/aei002. Epub 2004 Jul 26.
PubMed 15277302
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Galvanic Skin Response(GSR) to Measure Peripheral Block Activity
- ClinicalTrials.gov ID
- NCT05678777
- Acronym / sponsor ID
- 18/01/2022-2022/1-10
- Conditions
- Regional Anesthesia
- Keywords
- Galvanic Skin Response, Peripheral Block
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Adiyaman UniversityUniversity, hospital or other
- Study start
- 30 Jan 2022 (actual)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 10 Jan 2023 (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.
the investigators aim in this study is to determine whether the block is successful in successful infraclavicular brachial plexus blocks performed with USG, according to the change in GSR value in the upper extremity blocked due to sympathetic nerve blockade. Block success will be evaluated by sensory and motor examination of the blocked arm.
Detailed description
Peripheral nerve block is one of the commonly used blocks in regional anesthesia. In regional anesthesia applications, there are important advantages such as being conscious of the patient, expressing his complaints, continuation of spontaneous breathing, preservation of airway reflexes, continuation of analgesia in the postoperative period and early mobilization of the patient.
In 1978, ultrasound (USG) was used for the first time in peripheral nerve block. With USG, it is possible to monitor the nerves and anatomical structures, follow the needle, and reduce the dose by monitoring the distribution of the local anesthetic administered. Therefore, USG-guided peripheral nerve blocks are frequently used in anesthesia practice.
The Galvanic Skin Response (GSR) is a simple way to obtain autonomic nervous system dependent sweat gland function as a parameter.
Physically, the galvanic skin response is the change in the electrical structure of the skin to various stimuli. Changes in tension measured from the skin surface are recorded. The galvanic skin response is a useful, simple and reproducible electrophysiological technique for investigating sympathetic nervous system function.
The relaxation, calming response that accompanies an increase in skin resistance (causing a decrease in GSR meter) is the body's combat response that accompanies a decrease in skin resistance (causing an increase in GSR meter). Generally, low conductivity is a sign of relaxation. High conductivity is a sign of emotional, mental, or physical arousal. The galvanic skin response is a simple way to obtain autonomic nervous system-related sweat gland function as a parameter.
the investigators aim in this study is to determine whether the block is successful in successful infraclavicular brachial plexus blocks performed with USG, according to the change in GSR value in the upper extremity blocked due to sympathetic nerve blockade. Block success will be evaluated by sensory and motor examination of the blocked arm. The relaxation, calming response that accompanies an increase in skin resistance (causing a decrease in GSR meter) is the body's combat response that accompanies a decrease in skin resistance (causing an increase in GSR meter). Generally, low conductivity is a sign of relaxation. High conductivity is a sign of emotional, mental, or physical arousal.
In the investigators clinic, peripheral nerve blocks accompanied by USG are frequently used in anesthesia practice.
OBJECTİVE: Successful peripheral nerve blockade results in local vasodilation, increased local blood flow, and some increase in skin temperature due to sympathetic fiber blocking. However, in busy operating room conditions, these clinical signs may not appear quickly enough to confirm block adequacy, especially before or during surgery, and may not be used for clinical decision making. Traditional methods for assessing block success are time consuming and require patient cooperation. For the success of the block, it is aimed to use the Galvanic Skin Response (GSR) value, which is a non-invasive method that does not require patient cooperation and provides rapid evaluation.
Galvanic Skin Response (GSR) measurement is a non-invasive and rapid assessment that allows us to observe the skin resistance change with two probes attached to the fingertip. In the investigators study, we aimed to show that the Galvanic Skin Response (GSR) measurement method is a reliable and objective method to evaluate the adequacy of peripheral nerve blocks.
METHODS: This research; It is a prospective observational study. In patients who have performed infraclavicular brachial plexus block; The correlation of Galvanic skin response (GSR) values measured with the finger probe that we attached to the patient's two fingers before and after the block, with the success of the block will be examined. the investigators study is not invasive, it is only in the form of examining finger probe measurements and will not create an additional cost for the investigators hospital and the participants..
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients aged 18-65 who will undergo upper extremity surgery
Key inclusion criteria (3 listed)
- ASA1-ASA2 patients
- Patients between the ages of 18-65
- Patients who underwent infraclavicular block
Key exclusion criteria (8 listed)
- ASA3-ASA4 patients
- Patients younger than 18 years old and over 65 years old
- Patients who do not want to be included in the study
- Patients in whom infraclavicular brachial plexus block is contraindicated
- Patients who cannot cooperate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Galvanic Skin ResponseThe probe will be attached to the patient's finger and the Galvanic Skin Response will be measured | Device | – |
Primary outcome
Galvanic Skin Response
Time frame: 30/01/2023-28/02/2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Background: PubMed 11585030Tarvainen MP, Koistinen AS, Valkonen-Korhonen M, Partanen J, Karjalainen PA. Analysis of galvanic skin responses with principal components and clustering techniques. IEEE Trans Biomed Eng. 2001 Oct;48(10):1071-9. doi: 10.1109/10.951509.
- Results publication: PubMed 15277302Marhofer P, Greher M, Kapral S. Ultrasound guidance in regional anaesthesia. Br J Anaesth. 2005 Jan;94(1):7-17. doi: 10.1093/bja/aei002. Epub 2004 Jul 26.
- Individual participant dataSharing planned: Undecided. ı am undecided about sharing individual participant data with other researchers
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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.
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 Regional Anesthesia, run by Adiyaman University 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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 10 Jan 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Öznur Uludağ (05052309730 ext. 04162231690, uludagoznur@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Galvanic Skin Response (time frame: 30/01/2023-28/02/2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05678777, which also lists 2 linked publications.
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 10 Jan 2023.