Regional AnaesthsiaNCT07092891
Early Detection of Supraclavicular Brachial Plexus Block Failure Using Infrared Thermography and Perfusion Index
A study testing Ultrasound-Guided Supraclavicular Block, Bupivacaine Hydrochloride 0.5 % Injectable Solution and Ultrasound in people with Regional Anaesthsia and Brachial Plexus Blocks, run by Assiut University.
Trial summary
Successful peripheral nerve blockade is fundamental to modern regional anesthesia, particularly for upper limb surgeries. Ensuring the efficacy of a nerve block early in the perioperative period is critical, as delayed recognition of block failure may lead to intraoperative pain, the need for additional sedation or… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Regional Anaesthsia, Brachial Plexus Blocks
- What is being tested?
- Ultrasound-Guided Supraclavicular Block, Bupivacaine Hydrochloride 0.5 % Injectable Solution and Ultrasound
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2025to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-70 years
- ASA Physical Status I-III
Who cannot join
- General
- Coagulopathy
- Allergy to local anesthetics
- Special
- Neurological deficits in the affected limb
- Peripheral vascular disease or Raynaud's phenomenon
- Infections or skin lesions at the site of injection
- Use of a tourniquet
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Tarek Ashraf Ibrahim Abd Al-Hafiz, resident doctor contact
About this study
Official title: Early Detection of Supraclavicular Brachial Plexus Block Failure Using Infrared Thermography and Perfusion Index: Randomized Double-Blind Controlled Study
Successful peripheral nerve blockade is fundamental to modern regional anesthesia, particularly for upper limb surgeries. Ensuring the efficacy of a nerve block early in the perioperative period is critical, as delayed recognition of block failure may lead to intraoperative pain, the need for additional sedation or general anesthesia, and overall poorer patient outcomes. Conventional methods for assessing block success, such as sensory testing with pinprick or cold stimuli and motor assessment using strength scales, require patient cooperation and often take 15-30 minutes to yield definitive results. These delays are especially limiting in fast-paced surgical environments or when early decisions regarding anesthesia management are necessary.
Emerging non-invasive monitoring technologies offer promising alternatives for the early, objective assessment of block efficacy. Infrared Thermography (IRT) measures skin surface temperature, which increases due to sympathetic nerve blockade-induced vasodilation.
Read the detailed description
Successful peripheral nerve blockade is fundamental to modern regional anesthesia, particularly for upper limb surgeries. Ensuring the efficacy of a nerve block early in the perioperative period is critical, as delayed recognition of block failure may lead to intraoperative pain, the need for additional sedation or general anesthesia, and overall poorer patient outcomes. Conventional methods for assessing block success, such as sensory testing with pinprick or cold stimuli and motor assessment using strength scales, require patient cooperation and often take 15-30 minutes to yield definitive results. These delays are especially limiting in fast-paced surgical environments or when early decisions regarding anesthesia management are necessary.
Emerging non-invasive monitoring technologies offer promising alternatives for early, objective assessment of block efficacy. Infrared Thermography (IRT) measures skin surface temperature, which increases with sympathetic nerve blockade-induced vasodilation. Perfusion Index (PI), derived from pulse oximetry, reflects peripheral perfusion and also rises as vascular tone decreases following a successful nerve block. Both IRT and PI provide quantifiable, real-time physiological markers of sympathetic and circulatory changes that precede full sensory or motor blockade. Although several studies support their individual utility, there is limited evidence on their combined predictive value or their integration into routine clinical practice. Further investigation is needed to validate their role in enhancing the accuracy and timeliness of block assessment.
- Conditions
- Regional Anaesthsia, Brachial Plexus Blocks
- Being tested
- Ultrasound-Guided Supraclavicular Block, Bupivacaine Hydrochloride 0.5 % Injectable Solution, Ultrasound, Infrared Thermography Camera, Pulse Oximeter
- Keywords
- Brachial Plexus Blocks, Regional Anaesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Supraclavicular BlockProcedure or surgery
Ultrasound-guided supraclavicular brachial plexus block using a high-frequency linear ultrasound probe-real-time visualization of the brachial plexus for precise anesthetic delivery.
Bupivacaine Hydrochloride 0.5 % Injectable SolutionDrug
30 mL used for supraclavicular brachial plexus block
UltrasoundDevice
Imaging for block placement
Infrared Thermography CameraDevice
Skin temperature monitoring
Pulse OximeterDevice
Perfusion Index monitoring
| Study group | Role | What they receive |
|---|---|---|
| Supraclavicular Brachial Plexus Block with Thermographic and Perfusion Monitoring | Experimental | Participants will receive an ultrasound-guided supraclavicular brachial plexus block using 30 mL of 0.5% bupivacaine for upper limb surgery. Infrared thermography and perfusion index measurements will be recorded at baseline, and at 5, 10, and 15 minutes post-block to detect early physiological changes. Clinical assessment of sensory and motor block will be performed at 20 minutes post-injection using standardized testing. The goal is to evaluate the predictive accuracy of these non-invasive measures in detecting block success or failure. Receives: Procedure: Ultrasound-Guided Supraclavicular Block; Drug: Bupivacaine Hydrochloride 0.5 % Injectable Solution; Device: Ultrasound; Device: Infrared Thermography Camera; Device: Pulse Oximeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Skin Temperature (°C) Measured by Infrared Thermography From Baseline to 10 Minutes Post-block.
Mean change in skin temperature on the operative limb captured using infrared thermography at defined time points.
Measured: Baseline, 5, and 10 minutes post-injection
Change in Perfusion Index From Baseline to 10 Minutes Post-block
PI measured via pulse oximeter; change calculated as ratio to baseline values.
Measured: Baseline, 5, and 10 minutes post-injection
Secondary outcomes (1)
Correlation Between Changes in Skin Temperature and Perfusion Index With Sensory and Motor Block Scores at 20 Minutes
Correlation between physiologic changes and clinical assessments of sensory and motor block success using pinprick/cold test and Modified Bromage Scale.
Measured: 20 minutes post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start15 Aug 2025 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Sep 2026 (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 AnaesthsiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek Ashraf Ibrahim Abd Al-Hafiz, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07092891
- Sponsor's protocol ID
- Brachial Plexus Block Failure
- Status last verified
- Jul 2025
- First submitted
- 15 Jul 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gamal M, Hasanin A, Adly N, Mostafa M, Yonis AM, Rady A, Abdallah NM, Ibrahim M, Elsayad M. Thermal Imaging to Predict Failed Supraclavicular Brachial Plexus Block: A Prospective Observational Study. Local Reg Anesth. 2023 Jun 9;16:71-80. doi: 10.2147/LRA.S406057. eCollection 2023.
PubMed 37323293Abdelnasser A, Abdelhamid B, Elsonbaty A, Hasanin A, Rady A. Predicting successful supraclavicular brachial plexus block using pulse oximeter perfusion index. Br J Anaesth. 2017 Aug 1;119(2):276-280. doi: 10.1093/bja/aex166.
PubMed 28854539
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Supraclavicular Brachial Plexus Block Failure Using Infrared Thermography and Perfusion Index: Randomized Double-Blind Controlled Study
- ClinicalTrials.gov ID
- NCT07092891
- Acronym / sponsor ID
- Brachial Plexus Block Failure
- Conditions
- Regional Anaesthsia, Brachial Plexus Blocks
- Keywords
- Brachial Plexus Blocks, Regional Anaesthesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 30 Jul 2025 (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.
Successful peripheral nerve blockade is fundamental to modern regional anesthesia, particularly for upper limb surgeries. Ensuring the efficacy of a nerve block early in the perioperative period is critical, as delayed recognition of block failure may lead to intraoperative pain, the need for additional sedation or general anesthesia, and overall poorer patient outcomes. Conventional methods for assessing block success, such as sensory testing with pinprick or cold stimuli and motor assessment using strength scales, require patient cooperation and often take 15-30 minutes to yield definitive results. These delays are especially limiting in fast-paced surgical environments or when early decisions regarding anesthesia management are necessary.
Emerging non-invasive monitoring technologies offer promising alternatives for the early, objective assessment of block efficacy. Infrared Thermography (IRT) measures skin surface temperature, which increases due to sympathetic nerve blockade-induced vasodilation.
Detailed description
Successful peripheral nerve blockade is fundamental to modern regional anesthesia, particularly for upper limb surgeries. Ensuring the efficacy of a nerve block early in the perioperative period is critical, as delayed recognition of block failure may lead to intraoperative pain, the need for additional sedation or general anesthesia, and overall poorer patient outcomes. Conventional methods for assessing block success, such as sensory testing with pinprick or cold stimuli and motor assessment using strength scales, require patient cooperation and often take 15-30 minutes to yield definitive results. These delays are especially limiting in fast-paced surgical environments or when early decisions regarding anesthesia management are necessary.
Emerging non-invasive monitoring technologies offer promising alternatives for early, objective assessment of block efficacy. Infrared Thermography (IRT) measures skin surface temperature, which increases with sympathetic nerve blockade-induced vasodilation. Perfusion Index (PI), derived from pulse oximetry, reflects peripheral perfusion and also rises as vascular tone decreases following a successful nerve block. Both IRT and PI provide quantifiable, real-time physiological markers of sympathetic and circulatory changes that precede full sensory or motor blockade. Although several studies support their individual utility, there is limited evidence on their combined predictive value or their integration into routine clinical practice. Further investigation is needed to validate their role in enhancing the accuracy and timeliness of block assessment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supraclavicular Brachial Plexus Block with Thermographic and Perfusion Monitoring | Experimental | Procedure: Ultrasound-Guided Supraclavicular Block, Drug: Bupivacaine Hydrochloride 0.5 % Injectable Solution, Device: Ultrasound, Device: Infrared Thermography Camera, Device: Pulse OximeterParticipants will receive an ultrasound-guided supraclavicular brachial plexus block using 30 mL of 0.5% bupivacaine for upper limb surgery. Infrared thermography and perfusion index measurements will be recorded at baseline, and at 5, 10, and 15 minutes post-block to detect early physiological changes. Clinical assessment of sensory and motor block will be performed at 20 minutes post-injection using standardized testing. The goal is to evaluate the predictive accuracy of these non-invasive measures in detecting block success or failure. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged 18-70 years
- ASA Physical Status I-III
Key exclusion criteria (8 listed)
- General
- Special
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 |
|---|---|---|
| Ultrasound-Guided Supraclavicular BlockUltrasound-guided supraclavicular brachial plexus block using a high-frequency linear ultrasound probe-real-time visualization of the brachial plexus for precise anesthetic delivery. | Procedure or surgery | Supraclavicular Brachial Plexus Block with Thermographic and Perfusion Monitoring |
| Bupivacaine Hydrochloride 0.5 % Injectable Solution30 mL used for supraclavicular brachial plexus block | Drug | Supraclavicular Brachial Plexus Block with Thermographic and Perfusion Monitoring |
| UltrasoundImaging for block placement | Device | Supraclavicular Brachial Plexus Block with Thermographic and Perfusion Monitoring |
| Infrared Thermography CameraSkin temperature monitoring | Device | Supraclavicular Brachial Plexus Block with Thermographic and Perfusion Monitoring |
| Pulse OximeterPerfusion Index monitoring | Device | Supraclavicular Brachial Plexus Block with Thermographic and Perfusion Monitoring |
Primary outcome
Change in Skin Temperature (°C) Measured by Infrared Thermography From Baseline to 10 Minutes Post-block.
Time frame: Baseline, 5, and 10 minutes post-injection
Mean change in skin temperature on the operative limb captured using infrared thermography at defined time points.
Change in Perfusion Index From Baseline to 10 Minutes Post-block
Time frame: Baseline, 5, and 10 minutes post-injection
PI measured via pulse oximeter; change calculated as ratio to baseline values.
1 secondary outcome
Correlation Between Changes in Skin Temperature and Perfusion Index With Sensory and Motor Block Scores at 20 Minutes
Time frame: 20 minutes post-injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Background: PubMed 37323293Gamal M, Hasanin A, Adly N, Mostafa M, Yonis AM, Rady A, Abdallah NM, Ibrahim M, Elsayad M. Thermal Imaging to Predict Failed Supraclavicular Brachial Plexus Block: A Prospective Observational Study. Local Reg Anesth. 2023 Jun 9;16:71-80. doi: 10.2147/LRA.S406057. eCollection 2023.
- Background: PubMed 28854539Abdelnasser A, Abdelhamid B, Elsonbaty A, Hasanin A, Rady A. Predicting successful supraclavicular brachial plexus block using pulse oximeter perfusion index. Br J Anaesth. 2017 Aug 1;119(2):276-280. doi: 10.1093/bja/aex166.
- Individual participant dataSharing planned: Undecided
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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.
Tarek Ashraf Ibrahim Abd Al-Hafiz, resident doctor contact
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-Guided Supraclavicular Block, Bupivacaine Hydrochloride 0.5 % Injectable Solution and Ultrasound in people with Regional Anaesthsia and Brachial Plexus Blocks, run by Assiut University.
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 2 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: opening soon, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tarek Ashraf Ibrahim Abd Al-Hafiz, resident doctor (+201092002284, tarek.15235463@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Skin Temperature (°C) Measured by Infrared Thermography From Baseline to 10 Minutes Post-block. (time frame: Baseline, 5, and 10 minutes post-injection). The study lists 2 primary outcomes in all. 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 NCT07092891, 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 30 Jul 2025.