Elective Upper Limb Surgery Distal to the ElbowNCT07745985
Early Detection of Ulnar Sparing After Supraclavicular Block Using Infrared Thermography and Perfusion Index
An observational study of Elective Upper Limb Surgery Distal to the Elbow, run by Fayoum University.
Trial summary
Aim of the Study The aim of this study is to evaluate the effectiveness of early temperature changes measured by infrared thermography and perfusion index monitoring in predicting ulnar nerve sparing following ultrasound-guided supraclavicular brachial plexus block. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Elective Upper Limb Surgery Distal to the Elbow
- What is being tested?
- Supraclavicular Block
- Type of treatment
- Surgery or procedure
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2026to 20 Jul 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients scheduled for elective upper limb surgery distal to the elbow under ultrasound-guided supraclavicular brachial plexus block.
Who may be able to join
- Adult patients aged 18-65 years.
- American Society of Anesthesiologists (ASA) physical status I-II.
- Scheduled for elective unilateral upper limb surgery.
Who cannot join
- Peripheral neuropathy
- Raynaud's disease or peripheral vascular disease
- Diabetes mellitus with neuropathy
- Infection at injection site
- Allergy to local anesthetics
- BMI > 35 kg/m²
- Preexisting temperature asymmetry between limbs
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Early Detection of Ulnar Sparing After Supraclavicular Block Using Infrared Thermography and Perfusion Index: A Prospective Observational Study
Aim of the Study The aim of this study is to evaluate the effectiveness of early temperature changes measured by infrared thermography and perfusion index monitoring in predicting ulnar nerve sparing following ultrasound-guided supraclavicular brachial plexus block.
Patients and Methods Study Design This study will be a prospective observational diagnostic accuracy study conducted at the Department of Anesthesia, Surgical ICUS \&Pain Management in Fayoum University Hospital. The researcher will inform the participants about the objectives of the study, the examination, and the investigation that will be done. Also, the confidentiality of their information and their right not to participate in the study. Written informed consent will be obtained from all patients included in the study.
Read more
Study Population Adult patients scheduled for elective upper limb surgery distal to the elbow under ultrasound-guided supraclavicular brachial plexus block.
Inclusion Criteria
- Adult patients aged 18-65 years.
- American Society of Anesthesiologists (ASA) physical status I-II.
- Scheduled for elective unilateral upper limb surgery. Exclusion Criteria
- Peripheral neuropathy 2. Raynaud's disease or peripheral vascular disease 3. Diabetes mellitus with neuropathy 4. Infection at injection site 5. Allergy to local anesthetics 6. BMI > 35 kg/m² 7. Preexisting temperature asymmetry between limbs Interventions Ninty-two patients will receive ultrasound-guided supraclavicular brachial plexus block using a high-frequency linear probe. A standardized volume (30 mL) of local anesthetic mixture will be injected using in-plane technique. The block will be performed by experienced anesthesiologists.
Measurements Baseline
- Skin temperature at:
- Tip of the little finger (ulnar nerve territory)
- Tip of index finger (median nerve territory)
- Dorsal base of index finger (radial nerve territory)
- Perfusion index at corresponding digits Post-block Assessments Temperature and PI measurements will be recorded at the baseline, every 1 min for the first 10 min after local anesthetic injection, and then every 3 min in the following 21 min.
Temperature will be measured using a calibrated infrared thermographic camera under standardized ambient conditions (room temperature controlled, no external heat sources).
Perfusion index will be recorded using a pulse oximeter probe placed on the finger.
The Perfusion Index Ratio (PIR) is defined as the ratio of the perfusion index measured after an intervention to the baseline perfusion index:
Clinical Block Assessment
Sensory block will be assessed every 5 minutes using cold sensation and pinprick testing in the dermatomal distribution of:
- Ulnar nerve
- Median nerve
- Radial nerve
- Musculocutaneous nerve Block will be considered successful if complete sensory loss occurs within 30 minutes. Ulnar sparing will be defined as preserved sensation in ulnar territory requiring supplemental anesthesia.
Patients with overlapping failure in other nerve territories will be excluded from isolated ulnar sparing analysis when evaluating segment-specific outcomes.
Outcomes Primary Outcome The ability of perfusion index ratio and temperature changes at little fingers for predicting ulnar nerve sparing at 5 mins.
Secondary Outcomes
- The ability of perfusion index ratio and temperature changes at little fingers for predicting ulnar nerve sparing along with other time trends, in the first 30 mins.
- Time needed to reach maximum perfusion index ratio and maximum temperature changes in cases of successful brachial plexus block and in cases of ulnar spared block.
- Sensitivity, specificity, positive predictive value, and negative predictive value.
- Receiver operating characteristic (ROC) curve analysis. Sample size calculation The sample size was determined based on the methodology for comparing the area under the receiver operating characteristic (ROC) curve (AUC), using MedCalc Statistical Software (version 23; MedCalc Software, Belgium). An expected AUC of 0.92 was assumed for infrared thermography, as reported by Gamal et al. (2023). The minimum clinically acceptable AUC was set at 0.79, representing the lower bound of diagnostic performance reported for the perfusion index [4,5].
A two-sided type I error rate (α) of 0.05 and a type II error rate (β) of 0.20 (corresponding to 80% power) were specified. The ratio of positive to negative cases was set at 0.194, assuming an an anticipated ulnar sparing prevalence of 16% reported in the literature (Gamal et al., 2023). Based on these assumptions, the required sample size was calculated to be 77 patients in the successful block group and 15 patients in the ulnar sparing group, yielding a total sample size of 92 patients.
- Being tested
- Supraclavicular Block
- Keywords
- supraclavicular brachial plexus block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supraclavicular BlockProcedure or surgery
Ninety-two patients will receive an ultrasound-guided supraclavicular brachial plexus block using a high-frequency linear probe. A standardized volume (30 mL) of local anesthetic mixture will be injected using the in-plane technique. The block will be performed by experienced anesthesiologists.
| Study group | Role | What they receive |
|---|---|---|
| Ninety-two patients will receive an ultrasound-guided supraclavicular brachial plexus block using a | Adult patients scheduled for elective upper limb surgery distal to the elbow under ultrasound-guided supraclavicular brachial plexus block. Receives: Procedure: Supraclavicular Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perfusion index ratio at the little finger
Change in the perfusion index ratio measured at the little finger 5 minutes after the intervention. The perfusion index ratio will be evaluated for its ability to predict ulnar nerve sparing
Measured: 5 minutes
Temperature change at the little finger
Temperature change (°C) measured at the little finger 5 minutes after block performance.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start20 Jul 2026 (estimated)
- Primary completion20 Jul 2027 (estimated)
- Study completion20 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective Upper Limb Surgery Distal to the ElbowStudies of the same condition, open and under way.
- More trials run by Fayoum 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 92 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Collaborators
- Fayoum University Hospital
- Responsible party
- Principal investigator, Mohamed Ahmed Hamed, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07745985
- Sponsor's protocol ID
- M905
- Status last verified
- Aug 2026
- First submitted
- 18 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Ulnar Sparing After Supraclavicular Block Using Infrared Thermography and Perfusion Index: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07745985
- Acronym / sponsor ID
- M905
- Keywords
- supraclavicular brachial plexus block
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Collaborators
- Fayoum University Hospital
- Study start
- 20 Jul 2026 (estimated)
- Primary completion
- 20 Jul 2027 (estimated)
- Study completion
- 20 Jul 2027 (estimated)
- First posted
- 4 Aug 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.
Aim of the Study The aim of this study is to evaluate the effectiveness of early temperature changes measured by infrared thermography and perfusion index monitoring in predicting ulnar nerve sparing following ultrasound-guided supraclavicular brachial plexus block.
Patients and Methods Study Design This study will be a prospective observational diagnostic accuracy study conducted at the Department of Anesthesia, Surgical ICUS \&Pain Management in Fayoum University Hospital. The researcher will inform the participants about the objectives of the study, the examination, and the investigation that will be done. Also, the confidentiality of their information and their right not to participate in the study. Written informed consent will be obtained from all patients included in the study.
Study Population Adult patients scheduled for elective upper limb surgery distal to the elbow under ultrasound-guided supraclavicular brachial plexus block.
Inclusion Criteria
- Adult patients aged 18-65 years.
- American Society of Anesthesiologists (ASA) physical status I-II.
- Scheduled for elective unilateral upper limb surgery. Exclusion Criteria
- Peripheral neuropathy 2. Raynaud's disease or peripheral vascular disease 3. Diabetes mellitus with neuropathy 4. Infection at injection site 5. Allergy to local anesthetics 6. BMI > 35 kg/m² 7. Preexisting temperature asymmetry between limbs Interventions Ninty-two patients will receive ultrasound-guided supraclavicular brachial plexus block using a high-frequency linear probe. A standardized volume (30 mL) of local anesthetic mixture will be injected using in-plane technique. The block will be performed by experienced anesthesiologists.
Measurements Baseline
- Skin temperature at:
- Tip of the little finger (ulnar nerve territory)
- Tip of index finger (median nerve territory)
- Dorsal base of index finger (radial nerve territory)
- Perfusion index at corresponding digits Post-block Assessments Temperature and PI measurements will be recorded at the baseline, every 1 min for the first 10 min after local anesthetic injection, and then every 3 min in the following 21 min.
Temperature will be measured using a calibrated infrared thermographic camera under standardized ambient conditions (room temperature controlled, no external heat sources).
Perfusion index will be recorded using a pulse oximeter probe placed on the finger.
The Perfusion Index Ratio (PIR) is defined as the ratio of the perfusion index measured after an intervention to the baseline perfusion index:
Clinical Block Assessment
Sensory block will be assessed every 5 minutes using cold sensation and pinprick testing in the dermatomal distribution of:
- Ulnar nerve
- Median nerve
- Radial nerve
- Musculocutaneous nerve Block will be considered successful if complete sensory loss occurs within 30 minutes. Ulnar sparing will be defined as preserved sensation in ulnar territory requiring supplemental anesthesia.
Patients with overlapping failure in other nerve territories will be excluded from isolated ulnar sparing analysis when evaluating segment-specific outcomes.
Outcomes Primary Outcome The ability of perfusion index ratio and temperature changes at little fingers for predicting ulnar nerve sparing at 5 mins.
Secondary Outcomes
- The ability of perfusion index ratio and temperature changes at little fingers for predicting ulnar nerve sparing along with other time trends, in the first 30 mins.
- Time needed to reach maximum perfusion index ratio and maximum temperature changes in cases of successful brachial plexus block and in cases of ulnar spared block.
- Sensitivity, specificity, positive predictive value, and negative predictive value.
- Receiver operating characteristic (ROC) curve analysis. Sample size calculation The sample size was determined based on the methodology for comparing the area under the receiver operating characteristic (ROC) curve (AUC), using MedCalc Statistical Software (version 23; MedCalc Software, Belgium). An expected AUC of 0.92 was assumed for infrared thermography, as reported by Gamal et al. (2023). The minimum clinically acceptable AUC was set at 0.79, representing the lower bound of diagnostic performance reported for the perfusion index [4,5].
A two-sided type I error rate (α) of 0.05 and a type II error rate (β) of 0.20 (corresponding to 80% power) were specified. The ratio of positive to negative cases was set at 0.194, assuming an an anticipated ulnar sparing prevalence of 16% reported in the literature (Gamal et al., 2023). Based on these assumptions, the required sample size was calculated to be 77 patients in the successful block group and 15 patients in the ulnar sparing group, yielding a total sample size of 92 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ninety-two patients will receive an ultrasound-guided supraclavicular brachial plexus block using a | – | Procedure: Supraclavicular BlockAdult patients scheduled for elective upper limb surgery distal to the elbow under ultrasound-guided supraclavicular brachial plexus block. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients scheduled for elective upper limb surgery distal to the elbow under ultrasound-guided supraclavicular brachial plexus block.
Key inclusion criteria (3 listed)
- Adult patients aged 18-65 years.
- American Society of Anesthesiologists (ASA) physical status I-II.
- Scheduled for elective unilateral upper limb surgery.
Key exclusion criteria (7 listed)
- Peripheral neuropathy
- Raynaud's disease or peripheral vascular disease
- Diabetes mellitus with neuropathy
- Infection at injection site
- Allergy to local anesthetics
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 |
|---|---|---|
| Supraclavicular BlockNinety-two patients will receive an ultrasound-guided supraclavicular brachial plexus block using a high-frequency linear probe. A standardized volume (30 mL) of local anesthetic mixture will be injected using the in-plane technique. The block will be performed by experienced anesthesiologists. | Procedure or surgery | Ninety-two patients will receive an ultrasound-guided supraclavicular brachial plexus block using a |
Primary outcome
Perfusion index ratio at the little finger
Time frame: 5 minutes
Change in the perfusion index ratio measured at the little finger 5 minutes after the intervention. The perfusion index ratio will be evaluated for its ability to predict ulnar nerve sparing
Temperature change at the little finger
Time frame: 5 minutes
Temperature change (°C) measured at the little finger 5 minutes after block performance.
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 4 Aug 2026.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Elective Upper Limb Surgery Distal to the Elbow, run by Fayoum 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 3 inclusion and 7 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 4 Aug 2026. 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 Ahmed Tarek Abd El Azim, MCs (+20 10 67535636, AHMEDTAHA42000@GMAIL.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perfusion index ratio at the little finger (time frame: 5 minutes). 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?
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 4 Aug 2026.