Forearm SurgeriesNCT07909941
Perfusion Index in Monitoring Recovery From Brachial Plexus Block After Forearm Surgery
A study testing Perfusion index measurement in people with Forearm Surgeries and Brachial Plexus Blockade, run by Adiyaman University Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Postoperative differentiation between residual regional anesthetic effect and other causes of persistent sensory or motor deficit is a common clinical problem after peripheral nerve blocks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Forearm Surgeries, Brachial Plexus Blockade
- What is being tested?
- Perfusion index measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2026to 31 Dec 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years
- ASA physical status I-II
- Scheduled for elective forearm surgery under ultrasound-guided infraclavicular brachial plexus block
- Able to cooperate with sensory and motor assessments
- Written informed consent
Who cannot join
- Refusal to participate
- Preoperative neurological deficit in the operated limb
- Peripheral vascular disease or Raynaud phenomenon
- Diabetic neuropathy or other peripheral neuropathy
- Pathology, injury, infection, edema or skin lesion of the ipsilateral/contralateral arm that may interfere with perfusion index measurement
- Use of vasoactive medications that may affect peripheral perfusion
Show all 10Show fewer
- Allergy to local anesthetics
- Coagulopathy or infection at the block site
- Failed block or conversion to general anesthesia
- Block-related complications requiring protocol deviation (e.g., local anesthetic systemic toxicity)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Adıyaman University Training and Research Hospital
Adıyaman, Adıyaman Province, 02200
NEZİR YILMAZ, 05068939496, yilmaznezir@hotmail.com
About this study
Official title: Perfusion Index as a Noninvasive Indicator of Brachial Plexus Block Offset: Establishing Cut-Off Values for Sensory and Motor Recovery After Ultrasound-Guided Infraclavicular Brachial Plexus Block
Postoperative differentiation between residual regional anesthetic effect and other causes of persistent sensory or motor deficit is a common clinical problem after peripheral nerve blocks. Perfusion index (PI), a noninvasive pulse oximetry-derived measure of peripheral perfusion, rises after sympathetic blockade and has been studied for predicting block success and duration. However, its ability to detect the resolution of a block has not been established. This prospective observational study will evaluate the diagnostic accuracy of the PI ratio between the blocked and contralateral hand for detecting sensory and motor block resolution in adult patients undergoing elective forearm surgery under ultrasound-guided infraclavicular brachial plexus block. PI, sensory block (pinprick), and motor block will be assessed repeatedly from before the block until 24 hours postoperatively. Cut-off values of the PI ratio for the first regression and the complete resolution of sensory and motor block will be determined using ROC analysis.
Read the detailed description
Peripheral nerve blocks provide effective postoperative analgesia, but persistent numbness or weakness after surgery raises the question of whether the deficit reflects the expected duration of the local anesthetic or another cause, such as surgical or positioning-related nerve injury. Current assessment relies on repeated clinical examination and the passage of time. PI reflects peripheral vascular tone and increases in a blocked limb because of sympathetic blockade. Previous studies have examined PI mainly for predicting block success and duration; data on whether PI can objectively indicate the offset of block are lacking.
To determine the diagnostic accuracy of the PI ratio (blocked hand / contralateral hand) for detecting resolution of sensory and motor blockade after infraclavicular brachial plexus block, and to establish cut-off values for the first regression and complete resolution of each.
Prospective, single-center, observational diagnostic accuracy study. Fifty adult patients (18-65 years) scheduled for elective forearm surgery under infraclavicular brachial plexus block will be included after written informed consent. Patients with preoperative neurological deficit, peripheral vascular disease or Raynaud phenomenon, diabetic neuropathy, pathology of the contralateral arm, or failed block will be excluded or . The block technique, local anesthetic type, concentration, and volume will be standardized.
PI will be measured with a pulse oximeter probe placed on the same finger of both hands at the following time points: before the surgery; 5, 10, 15, and 30 minutes after the block; and 30, 60, 90, and 120 minutes, and 4, 6, 8, 12, 16, and 24 hours postoperatively. The PI ratio will be calculated as operated-side PI divided by contralateral-side PI. At each time point, sensory block will be assessed by pinprick and motor block will be assessed using a 4-point upper extremity motor scale by an investigator blinded to PI values: Grade 0, able to raise the extended arm to 90° for 2 s; Grade 1, able to flex the elbow and move the fingers but unable to raise the extended arm; Grade 2, unable to flex the elbow but able to move the fingers; Grade 3, inability to move the arm, elbow, or fingers. The time to first regression and the time to complete resolution of sensory and motor block will be recorded. Room temperature, tourniquet duration and pressure, surgery type, age, and analgesic consumption will be recorded as potential confounders.
The primary outcome is the diagnostic accuracy (ROC AUC, sensitivity, specificity) of the PI ratio for complete resolution of sensory and motor block. Secondary outcomes include the PI ratio cut-off for first regression, the time course of the PI ratio after block, and the relationship of the PI ratio with clinical block status. Because repeated measurements are obtained from each patient, analyses will account for within-patient correlation (e.g., cluster bootstrap or mixed-effects models). Optimal cut-offs will be determined using the Youden index with 95% confidence intervals.
If validated, the PI ratio may help clinicians judge whether a persistent postoperative deficit is plausibly attributable to residual block. The study is not designed to diagnose nerve injury; any patient with a persistent deficit will be followed according to clinical practice.
- Conditions
- Forearm Surgeries, Brachial Plexus Blockade
- Being tested
- Perfusion index measurement
- Keywords
- forearm surgeries, brachial plexus blockade, perfusion index, motor block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perfusion index measurementDiagnostic test
Noninvasive measurement of perfusion index (PI) using a pulse oximeter probe placed on the same finger of both hands at predefined time points: before the block; 5, 10, 15 and 30 minutes after the block; and 30, 60, 90 and 120 minutes, and 4, 6, 8, 12, 16 and 24 hours postoperatively. The PI ratio (operated hand / contralateral hand) is calculated. The measurement does not alter anesthetic or surgical management.
| Study group | Role | What they receive |
|---|---|---|
| Infraclavicular block group | Other | Adult patients (18-65 years) undergoing elective forearm surgery under ultrasound-guided infraclavicular brachial plexus block. Perfusion index of both hands is measured noninvasively before the surgery, at 5, 10, 15 and 30 minutes after the block, and at 30, 60, 90 and 120 minutes, and 4, 6, 8, 12, 16 and 24 hours postoperatively. At each time point, sensory block (pinprick) and motor block (4-point upper extremity motor scale) are assessed. No treatment beyond routine anesthetic and surgical care is applied. Receives: Diagnostic Test: Perfusion index measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of perfusion index ratio for resolution of motor block
Area under the ROC curve, optimal cut-off value, sensitivity and specificity of the perfusion index ratio (operated hand / contralateral hand) for detecting complete resolution of motor block after infraclavicular brachial plexus block. Complete resolution is defined as Grade 0 on the 4-point upper extremity motor scale (able to raise the extended arm to 90 degrees for 2 seconds). Motor status is assessed by a blinded investigator at each time point.
Measured: before the surgery, at 5, 10, 15 and 30 minutes after the block, and at 30, 60, 90 and 120 minutes, and 4, 6, 8, 12, 16 and 24 hours postoperatively
Diagnostic accuracy of perfusion index ratio for resolution of sensory block
Area under the ROC curve, optimal cut-off value, sensitivity and specificity of the perfusion index ratio (operated hand / contralateral hand) for detecting complete resolution of sensory block after infraclavicular brachial plexus block. Complete resolution is defined as pinprick sensation equal to that of the contralateral hand. Sensory status is assessed by a blinded investigator at each time point.
Measured: before the surgery, at 5, 10, 15 and 30 minutes after the block, and at 30, 60, 90 and 120 minutes, and 4, 6, 8, 12, 16 and 24 hours postoperatively
Secondary outcomes (2)
Perfusion index ratio cut-off for first regression of motor block
Area under the ROC curve, optimal cut-off value, sensitivity and specificity of the perfusion index ratio (operated hand / contralateral hand) for detecting the first regression of motor block after infraclavicular brachial plexus block. First regression is defined as the first decrease in motor grade on the 4-point upper extremity motor scale from the maximal block level, assessed by a blinded investigator.
Measured: Before the surgery, at 5, 10, 15 and 30 minutes after the block, and at 30, 60, 90 and 120 minutes, and 4, 6, 8, 12, 16 and 24 hours postoperatively
Perfusion index ratio cut-off for first regression of sensory block
Area under the ROC curve, optimal cut-off value , sensitivity and specificity of the perfusion index ratio (operated hand / contralateral hand) for detecting the first regression of sensory block after infraclavicular brachial plexus block. First regression is defined as the first return of pinprick sensation in the operated hand, assessed by a blinded investigator.
Measured: Before the surgery, at 5, 10, 15 and 30 minutes after the block, and at 30, 60, 90 and 120 minutes, and 4, 6, 8, 12, 16 and 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Forearm SurgeriesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-group, prospective diagnostic accuracy study. All participants are adult patients undergoing elective forearm surgery under ultrasound-guided infraclavicular brachial plexus block and receive the same assessments; there is no control or comparison arm and no randomization. Each patient serves as their own control, with the contralateral (non-blocked) hand used as the reference for calculating the perfusion index (PI) ratio (operated hand / contralateral hand). PI is measured noninvasively with a pulse oximeter probe on both hands before the block, at 5, 10, 15 and 30 minutes after the block, and at 30, 60, 90 and 120 minutes, and 4, 6, 8, 12, 16 and 24 hours postoperatively. At each time point, sensory block (pinprick) and motor block (4-point upper extremity motor scale) are assessed by an investigator blinded to PI values. No intervention beyond routine anesthetic and surgical care is applied, and PI measurement does not influence clinical management.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adiyaman University Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nezir Yılmaz, Adiyaman University Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07909941
- Sponsor's protocol ID
- ADYU-ANS-NY-017
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perfusion Index as a Noninvasive Indicator of Brachial Plexus Block Offset: Establishing Cut-Off Values for Sensory and Motor Recovery After Ultrasound-Guided Infraclavicular Brachial Plexus Block
- ClinicalTrials.gov ID
- NCT07909941
- Acronym / sponsor ID
- ADYU-ANS-NY-017
- Conditions
- Forearm Surgeries, Brachial Plexus Blockade
- Keywords
- forearm surgeries, brachial plexus blockade, perfusion index, motor block
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Adiyaman University Research HospitalUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Nov 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.
Postoperative differentiation between residual regional anesthetic effect and other causes of persistent sensory or motor deficit is a common clinical problem after peripheral nerve blocks. Perfusion index (PI), a noninvasive pulse oximetry-derived measure of peripheral perfusion, rises after sympathetic blockade and has been studied for predicting block success and duration. However, its ability to detect the resolution of a block has not been established. This prospective observational study will evaluate the diagnostic accuracy of the PI ratio between the blocked and contralateral hand for detecting sensory and motor block resolution in adult patients undergoing elective forearm surgery under ultrasound-guided infraclavicular brachial plexus block. PI, sensory block (pinprick), and motor block will be assessed repeatedly from before the block until 24 hours postoperatively. Cut-off values of the PI ratio for the first regression and the complete resolution of sensory and motor block will be determined using ROC analysis.
Detailed description
Peripheral nerve blocks provide effective postoperative analgesia, but persistent numbness or weakness after surgery raises the question of whether the deficit reflects the expected duration of the local anesthetic or another cause, such as surgical or positioning-related nerve injury. Current assessment relies on repeated clinical examination and the passage of time. PI reflects peripheral vascular tone and increases in a blocked limb because of sympathetic blockade. Previous studies have examined PI mainly for predicting block success and duration; data on whether PI can objectively indicate the offset of block are lacking.
To determine the diagnostic accuracy of the PI ratio (blocked hand / contralateral hand) for detecting resolution of sensory and motor blockade after infraclavicular brachial plexus block, and to establish cut-off values for the first regression and complete resolution of each.
Prospective, single-center, observational diagnostic accuracy study. Fifty adult patients (18-65 years) scheduled for elective forearm surgery under infraclavicular brachial plexus block will be included after written informed consent. Patients with preoperative neurological deficit, peripheral vascular disease or Raynaud phenomenon, diabetic neuropathy, pathology of the contralateral arm, or failed block will be excluded or . The block technique, local anesthetic type, concentration, and volume will be standardized.
PI will be measured with a pulse oximeter probe placed on the same finger of both hands at the following time points: before the surgery; 5, 10, 15, and 30 minutes after the block; and 30, 60, 90, and 120 minutes, and 4, 6, 8, 12, 16, and 24 hours postoperatively. The PI ratio will be calculated as operated-side PI divided by contralateral-side PI. At each time point, sensory block will be assessed by pinprick and motor block will be assessed using a 4-point upper extremity motor scale by an investigator blinded to PI values: Grade 0, able to raise the extended arm to 90° for 2 s; Grade 1, able to flex the elbow and move the fingers but unable to raise the extended arm; Grade 2, unable to flex the elbow but able to move the fingers; Grade 3, inability to move the arm, elbow, or fingers. The time to first regression and the time to complete resolution of sensory and motor block will be recorded. Room temperature, tourniquet duration and pressure, surgery type, age, and analgesic consumption will be recorded as potential confounders.
The primary outcome is the diagnostic accuracy (ROC AUC, sensitivity, specificity) of the PI ratio for complete resolution of sensory and motor block. Secondary outcomes include the PI ratio cut-off for first regression, the time course of the PI ratio after block, and the relationship of the PI ratio with clinical block status. Because repeated measurements are obtained from each patient, analyses will account for within-patient correlation (e.g., cluster bootstrap or mixed-effects models). Optimal cut-offs will be determined using the Youden index with 95% confidence intervals.
If validated, the PI ratio may help clinicians judge whether a persistent postoperative deficit is plausibly attributable to residual block. The study is not designed to diagnose nerve injury; any patient with a persistent deficit will be followed according to clinical practice.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-group, prospective diagnostic accuracy study. All participants are adult patients undergoing elective forearm surgery under ultrasound-guided infraclavicular brachial plexus block and receive the same assessments; there is no control or comparison arm and no randomization. Each patient serves as their own control, with the contralateral (non-blocked) hand used as the reference for calculating the perfusion index (PI) ratio (operated hand / contralateral hand). PI is measured noninvasively with a pulse oximeter probe on both hands before the block, at 5, 10, 15 and 30 minutes after the block, and at 30, 60, 90 and 120 minutes, and 4, 6, 8, 12, 16 and 24 hours postoperatively. At each time point, sensory block (pinprick) and motor block (4-point upper extremity motor scale) are assessed by an investigator blinded to PI values. No intervention beyond routine anesthetic and surgical care is applied, and PI measurement does not influence clinical management.
| Arm | Type | Receives |
|---|---|---|
| Infraclavicular block group | Other | Diagnostic Test: Perfusion index measurementAdult patients (18-65 years) undergoing elective forearm surgery under ultrasound-guided infraclavicular brachial plexus block. Perfusion index of both hands is measured noninvasively before the surgery, at 5, 10, 15 and 30 minutes after the block, and at 30, 60, 90 and 120 minutes, and 4, 6, 8, 12, 16 and 24 hours postoperatively. At each time point, sensory block (pinprick) and motor block (4-point upper extremity motor scale) are assessed. No treatment beyond routine anesthetic and surgical care is applied. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-65 years
- ASA physical status I-II
- Scheduled for elective forearm surgery under ultrasound-guided infraclavicular brachial plexus block
- Able to cooperate with sensory and motor assessments
- Written informed consent
Key exclusion criteria (10 listed)
- Refusal to participate
- Preoperative neurological deficit in the operated limb
- Peripheral vascular disease or Raynaud phenomenon
- Diabetic neuropathy or other peripheral neuropathy
- Pathology, injury, infection, edema or skin lesion of the ipsilateral/contralateral arm that may interfere with perfusion index measurement
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 |
|---|---|---|
| Perfusion index measurementNoninvasive measurement of perfusion index (PI) using a pulse oximeter probe placed on the same finger of both hands at predefined time points: before the block; 5, 10, 15 and 30 minutes after the block; and 30, 60, 90 and 120 minutes, and 4, 6, 8, 12, 16 and 24 hours postoperatively. The PI ratio (operated hand / contralateral hand) is calculated. The measurement does not alter anesthetic or surgical management. | Diagnostic test | Infraclavicular block group |
Primary outcome
Diagnostic accuracy of perfusion index ratio for resolution of motor block
Time frame: before the surgery, at 5, 10, 15 and 30 minutes after the block, and at 30, 60, 90 and 120 minutes, and 4, 6, 8, 12, 16 and 24 hours postoperatively
Area under the ROC curve, optimal cut-off value, sensitivity and specificity of the perfusion index ratio (operated hand / contralateral hand) for detecting complete resolution of motor block after infraclavicular brachial plexus block. Complete resolution is defined as Grade 0 on the 4-point upper extremity motor scale (able to raise the extended arm to 90 degrees for 2 seconds). Motor status is assessed by a blinded investigator at each time point.
Diagnostic accuracy of perfusion index ratio for resolution of sensory block
Time frame: before the surgery, at 5, 10, 15 and 30 minutes after the block, and at 30, 60, 90 and 120 minutes, and 4, 6, 8, 12, 16 and 24 hours postoperatively
Area under the ROC curve, optimal cut-off value, sensitivity and specificity of the perfusion index ratio (operated hand / contralateral hand) for detecting complete resolution of sensory block after infraclavicular brachial plexus block. Complete resolution is defined as pinprick sensation equal to that of the contralateral hand. Sensory status is assessed by a blinded investigator at each time point.
2 secondary outcomes
Perfusion index ratio cut-off for first regression of motor block
Time frame: Before the surgery, at 5, 10, 15 and 30 minutes after the block, and at 30, 60, 90 and 120 minutes, and 4, 6, 8, 12, 16 and 24 hours postoperatively
Perfusion index ratio cut-off for first regression of sensory block
Time frame: Before the surgery, at 5, 10, 15 and 30 minutes after the block, and at 30, 60, 90 and 120 minutes, and 4, 6, 8, 12, 16 and 24 hours postoperatively
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 2 Nov 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perfusion index measurement in people with Forearm Surgeries and Brachial Plexus Blockade, run by Adiyaman University Research Hospital 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 10 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 2 Nov 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?
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 NEZİR YILMAZ, Associate Professor (05068939496, yilmaznezir@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of perfusion index ratio for resolution of motor block (time frame: before the surgery, at 5, 10, 15 and 30 minutes after the block, and at 30, 60, 90 and 120 minutes, and 4, 6, 8, 12, 16 and 24 hours postoperatively). 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 2 Nov 2026.