Keywords
Peripheral arterial disease, Subarachnoid block, Femoropopliteal Block, Tissue oxygen saturation
Peripheral nerve blocks can induce vasodilation, benefiting patients with Peripheral Arterial Disease (PAD). However, the comparative vasodilatory effects of femoropopliteal versus neuraxial blocks remain unclear. This pilot study aimed to evaluate these effects by measuring changes in tissue oxygen saturation (StO2) using noninvasive NIRS.
This study was a single-blind, randomized, controlled trial conducted at Cipto Mangunkusumo General Hospital from July to November 2024 of patients with PAD who underwent lower limb surgeries. Subjects were randomly assigned to either group F (Femoropopliteal block) or group S (Subarachnoid block). StO2 was measured at baseline (pre-block) also 5, 15, and 30 minutes after block using NIRS. The main outcome is the delta increase in the StO2 in each time point between groups. The difference was analyzed with General Linear Model (GLM) with post-hoc Bonferroni correction.
A total of 16 patients took part in the study (8 in group F and 8 in group S), with a total of 24 observations (12 group F and 12 group S). Increased of StO2 was noticed as early as 5 minutes with mean delta StO2 of 1.4 ± 1.5 for the F group and 5.3 ± 5.2 for the S group (p=0.02). At minute 15, the values were 2.4 ± 1.2 for the F group and 6.6 ± 5.4 for the S group (p=0.02). At minute 30, the values were 2.9 ± 1.7 for the F group and 6.2 ± 4.4 for the S group (p=0.12).
Compared to subarachnoid block, increase of StO2 hence the vasodilatory effect of femoropopliteal block is modest.
The clinical trial number is NCT06702202
Peripheral arterial disease, Subarachnoid block, Femoropopliteal Block, Tissue oxygen saturation
Peripheral Arterial Disease (PAD) is a condition that involves narrowing or blockage of peripheral arteries, which results in decreased blood flow to the extremities.1 Many studies have shown that peripheral nerve blocks cause vasodilation in normal condition, yet only a few studies the vasodilation effect in patients with PAD.2 These subsets of patients would benefit the most from having a peripheral nerve block (PNB) and the underlying diseases may alter the degree of vasodilation following PNB.
Near-infrared spectroscopy (NIRS) is a spectroscopic method that uses the near-infrared region of the electromagnetic spectrum (from 780 nm to 2500 nm).3 The use of NIRS in vascular diseases has been of interest for almost half a century as it is a painless, cost-effective, and noninvasive technique that assesses the physiologic state of tissue perfusion, of which will be affected by vasodilation.4,5 Research by Capdevila et al. (2008) has shown that regional anesthesia in patients with PAD can provide local vasodilation and improve tissue perfusion.6 The vasodilatory effect occurring during peripheral nerve block has been shown to increase tissue oxygen saturation.4,5
Subarachnoid block is considered gold standard for lower limb surgeries and its sympatholytic effect is established.7 This was a pilot study aims to investigate the extent of vasodilatory effect induced by femoropopliteal block in patients with PAD by comparing changes in StO2 values between patients receiving femoropopliteal blocks and those receiving subarachnoid blocks.
The clinical trial number is NCT06702202.
After receiving approval from the Cipto Mangunkusumo National General Hospital Clinical Research Ethics Committee with the approval number KET-1027/UN2.F1/ETIK/PPM.00.02.2024 on July 1, 2024 and written informed consent, 16 adult patients with Peripheral Arterial Disease scheduled to undergo lower limb surgeries under femoropopliteal block or subarachnoid block in a 1:1 ratio, were successfully enrolled. Exclusion criteria were history of allergy to local anesthetics, infection on injection site, above knee lesion, non-intact skin on probe placement area. Dropout criteria were failed block as well as unobtainable data due to probe dislodgement or edema of extremities.
An investigator with no further involvement with the study generated the allocation sequence using computerized block randomization with 2 block sizes and concealed the allocation results in sealed, sequentially numbered envelopes. Subjects in group F were assigned to Femoropopliteal block, while group S underwent Subarachnoid block. For the purposes of the block procedure, the anesthesiologist performing the block was aware of the treatment assigned to the patient. There was a team dedicated to measuring purposes and they were blinded to any treatment assigned to patient.
In the operating theatre, initial StO2 measurements were taken prior to block. NIRS probes (Pulse Oximeter Masimo Radical-7® + Root® with NIRS, Masimo Corp, USA) was placed under the knee, on the lateral part of both leg ( Figure 1). After a 3-minute reading, the highest and lowest StO2 values at each point will be documented, with the median value from each point serving as the baseline.
Using linear transducer positioned at the inguinal fold to visualize the femoral nerve, 10 ml of Lidocaine 2% (Xylocaine™, AstraZenecaAB, Aspen Global Inc) was injected in-plane around the femoral nerve. For popliteal sciatic nerve blocks, linear transducer was placed transversally on the distal thigh to visualize Sciatic nerve just before branching, followed by the injection of 20 ml of Bupivacaine 0.5% (Marcain™, Astra Zeneca AB, Aspen Global Inc) through a 80 mm block needle, in-plane.
Patients may assume either a sitting or lateral decubitus position, and subsequent to aseptic procedures, a G27 spinal needle will be introduced into the L3-4 interspinous space until clear cerebrospinal fluid visualization, followed by the injection of 2.5 ml of 0.5% hyperbaric Bupivacaine.
StO2 values from each point were recorded at 5, 15, and 30 minutes after the blocks.
Continuous variables will first be analyzed for normality using Shapiro Wilk test. If the distribution is normal, the data will be presented in mean ± SD and if it is not normally distributed, it will be presented in median (min-max). Categorical variables will be written as n (%). Baseline characteristics include age, gender, BMI, diagnosis, surgery, comorbidity, and blood pressure. The main outcome is the delta increase in the StO2 in each time point between groups. The difference will be analyzed using the General Linear Model (GLM) with post-hoc Bonferroni correction. Statistical analysis will be carried out using SPSS 25.0 with p<0.05 considered significant.
A total of 20 patients scheduled for lower limb surgeries from July 2024 until November 2024 initially enrolled in this study, 3 patients were excluded due to the need of grafting from upper thigh, 1 patient dropped out because of bad reading from probe caused by edema of the leg. In the end, 16 patients were eligible for this study (8 in group F and 8 in group S), with a total of 24 observations (12 group F and 12 group S). A subset of subject were measured at two point level on ipsilateral side to investigate any difference readings in different anatomical location.
Patient characteristics are comparable between the two groups ( Table 1). The femoropopliteal group had a mean age of 53.5 years and a BMI of 21.1 kg/m2, while the subarachnoid group had a mean age of 58.8 years and a BMI of 24.4 kg/m2. Diagnosis in both groups was dominated by diabetic foot ulcer (DFU) and Chronic Limb Threatening Ischemia (CLTI), with a small percentage of vasculitis. Surgery types varied, with a higher rate of amputations in the subarachnoid group (75%) compared to the femoropopliteal group (50%).
Variable | Femoropopliteal n=12 | Subarachnoid n=12 | P value |
Total P value |
---|---|---|---|---|
Minute 5 delta, mean±SD | 1.4±1.5 | 5.3±5.2 | 0.020 | 0.816 |
Minute 15 delta, mean±SD | 2.4±1.2 | 6.6±5.4 | 0.016 | |
Minute 30 delta, mean±SD | 2.9±1.7 | 6.2±4.4 | 0.119 |
Diabetes and hypertension are common comorbidities found in both groups. Femoropopliteal group had a high prevalence of diabetes (75%) and hypertension (62.5%), while the subarachnoid group had even higher rates of these conditions, with 87.5% having diabetes and 87.5% hypertension. The femoropopliteal group showed higher pre-surgery systolic blood pressure (148.6 mmHg) compared to the subarachnoid group (139.5 mmHg). A total of 62.5% of the femoropopliteal and 62.5% of the subarachnoid group had chronic kidney disease and 37.5% of the femoropopliteal and 50% of the subarachnoid group had anemia
At baseline, the mean StO2 was 60.8±12.9 for the femoropopliteal group and 64 ± 9.8 for the subarachnoid group, with a P value of 0.506. At minute 5, the mean delta StO2 was 1.4 ± 1.5 for the femoropopliteal group and 5.3±5.2 for the subarachnoid group, with a P value of 0.020. At minute 15, the values were 2.4± 1.2 for femoropopliteal and 6.6 ±5.4 for subarachnoid, with a P value of 0.016. At minute 30, the values were 2.9 ±1.7 for femoropopliteal and 6.2± 4.4 for subarachnoid, with a P value of 0.119 ( Figure 2).
The vasodilation effect of peripheral nerve blocks has been widely utilized.4,5,8–11 Although many researches have been done, the extent of vasodilation effect from peripheral nerve blocks is not yet known, particularly in patients with PAD. This subset of patients would benefit the most from having a peripheral nerve block (PNB) and the underlying diseases may alter the degree of vasodilation following PNB. This research is a pilot study to compare the perfusion improvement in patients with peripheral arterial disease after femoropopliteal block versus subarachnoid block using Near-Infrared Spectroscopy (NIRS) monitoring. To our knowledge, this has not been studied before.
Near infrared spectroscopy is a technology in which oxygen saturation of hemoglobin is measured using near infrared (NIR) light. The percentage of hemoglobin saturated with oxygen is determined by passing specific wavelengths of light through blood and measuring its absorption. Since the amounts of light absorbed by oxygenated hemoglobin and by deoxygenated hemoglobin are different, the relative concentration of oxygenated hemoglobin can be determined.12 NIRS measures oxygenation saturation in all the vascular beds in the area of interest.9 Initially used to measure cerebral saturation, the use of NIRS for the evaluation of PAD has been mentioned in the literature.12,13
One comprehensive study by Karmakar et al. showed arterial vasodilation after axillary brachial plexus block.14 Peripheral vasodilation causes increase in tissue oxygen saturation.5 Van de Velde et al. (2016) found an increase in StO2 after a popliteal block.4 Lima et al. (2009) observed an increase in StO2 after an axillary brachial plexus block, while the control side did not increase.5 Zou et al. (2018) found an increase in StO2 after a successful femoral nerve block.15 Sargin et al. (2022) observed an increase in StO2 after an infraclavicular brachial plexus block.8 Complementing existing studies in healthy patients, our study shows an increase in StO2 after femoropopliteal block in patients with Peripheral Arterial Disease.
Compared with the increase in StO2 after subarachnoid block, the increase after femoropopliteal only block is modest (Figure 2). This indicates better vasodilation and increased perfusion after subarachnoid block. The mechanism of vasodilation induced by femoropopliteal block is said to be the interrupt the sensory (afferent) arc as well as the motor (efferent) arc of the autonomic reflex circuits.4 The sympathetic nerve block happened along the innervated blood vessels (postganglionic).14,16,17 The delta StO2 were found to be in wider range in the subarachnoid block group. There was a significantly higher increase in StO2 compared to the femoropopliteal block, but some samples showed no difference in delta StO2 compared to the femoropopliteal block. The vasodilation mechanism after a subarachnoid block is the sympathetic block at the preganglionic level.18 A higher sympathetic block level results in extensive vasodilation in the lower limb, decreased systemic vascular resistance, venous pooling, and reduced cardiac output.19 This possibly underlies the greater increase in StO2 compared to the femoropopliteal block in some patients, but on the other hand, decreased cardiac output can cause the opposite effect, so in some patients, the increase in StO2 is modest.
Our study shows that an increase in StO2 occurs within 5 minutes in both groups, consistent with the study by Karmakar, which found that regional hemodynamic changes occur within 5 minutes due to the small diameter of sympathetic nerve fibers, making them easier to block.14
Several things need to be considered when measuring StO2 with NIRS. One of them is the position of the probe. Barker et al. (2014) in their study noted varying StO2 values at different locations, but observed an increasing trend at all observation points.20 Variations in the thickness of subcutaneous fat represent a key factor that can substantially influence the degree of variability.3,4,12 This finding imply that heterogeneity in vessel density within the subcutaneous region may modulate NIRS measurements, offering a plausible explanation for the observed disparities in NIRS values across different anatomical locations. Nevertheless, it is conceivable that the dynamics of delta StO2 are less susceptible to this phenomenon. Vessel density appears to exert a more pronounced influence on absolute StO2 values, whereas its effect on the temporal or spatial trends of these measurements is likely to be comparatively minor.4 In this study, a subset of samples were measured at two ipsilateral points (proximal-distal) to confirm this. The results showed that StO2 differed at different probe positions on the same patient, but the trend consistently showed an increase, further confirming the importance of trend in value rather than absolute value.
Reduced pain also leads to decreased sympathetic signals.21 For this reason, the vasodilation likely does not follow the innervation area of the blocked peripheral nerve. Van De Velde (2016) found increased StO2 in the area innervated by the saphenous nerve after a popliteal block.4 Sargin and Uluer (2022) found increased StO2 not only in patients with a perfect block but also in those with a partial block, though not as high as in a complete block.8
Adequate tissue oxygenation depends on sufficient tissue blood flow and oxygen content.3 This value can change based on alterations in either oxygen consumption or oxygen delivery. NIRS however, is unable to distinguish between these causes. In this study, we categorized patients into subgroups based on significant delta StO2 (delta StO2 ≥ 5 based on clinical considerations) ( Table 3).
Group | Baseline StO2 | Delta Minute 30 | Hb | MAP |
---|---|---|---|---|
Spinal | 47 | 17 | 10.8 | 68 |
Spinal | 64 | 11 | 10 | 110 |
Spinal | 54 | 6 | 9.7 | 89 |
Femoropopliteal | 33 | 7 | 7.8 | 74 |
Spinal | 57 | 8 | 8.6 | 95 |
Spinal | 57 | 9 | 8.6 | 95 |
Spinal | 80 | 5 | 12.3 | 100 |
We obtained 7 samples with significant delta StO2, the majority came from the subarachnoid group (6 vs 1). Delta StO2 did not seem to be affected by Hb, where 4 of the 7 samples had Hb below 10 gr/dL. Of the seven samples, 6 samples had baseline StO2 of below 65. In general, significant increase in StO2 was influenced by the type of block (subarachnoid was more significant) and baseline StO2 (low baseline ≤ 65 compared to hemoglobin level). Severity of occlusion doesn’t seem to attenuate the extent of vasodilatory effect, as study found that significant increase in StO2 happened in low baseline StO2.
It should be noted in this study, our observation time was only up to 30 minutes. Based on the increasing trend in Figure 2, it can be seen that the trend of StO2 increase continued to grow. However, we noticed in group S the graph appears to start to decline at minute 30. Therefore, longer study period might be needed to assess whether the increase of StO2 will continue to be constant.
Our study is the first to investigate changes in StO2 after a peripheral nerve block in patients with peripheral arterial disease. Study showed increase in StO2 after femoropopliteal block indicating improvement in perfusion. However, if compared to subarachnoid block, increase in StO2 after femoropliteal block is only modest. We also found that hemoglobin level did not affect this effect. The limited sample size is a drawback of this study; however, we believe our results can provide insight for future studies.
This study has been approved by the Health Research Ethics Committee of the Faculty of Medicine, Universitas Indonesia - RSUPN Dr. Cipto Mangunkusumo, under approval number KET-1027/UN2.F1/ETIK/PPM.00.02.2024 on july 1, 2024. Written informed consent was obtained from all participants prior to their inclusion in the study, in compliance with the guidelines set by the ethics committee.
All authors have read and approved the final manuscript for publication. Written consent for publication was obtained from all participants involved in the study.
All author contribute in concept, design, definition of intellectual content, literature search, clinical studies, experimental studies, data analysis, statistical analysis, manuscript preparation, manuscript editing and manuscript review.
OSF. Dataset Subarachnoid Block and Femoropopliteal Block, https://doi.org/10.17605/OSF.IO/ZQDVG.23
The project contains the following underlying data:
Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).
ClinicalTrial.gov. Comparison of the Effect of Subarachnoid Block and Femoropopliteal Block to Limb Perfusion in Patients with Peripheral Arterial Disease. https://clinicaltrials.gov/study/NCT06702202.24
OSF. Dataset Subarachnoid Block and Femoropopliteal Block, https://doi.org/10.17605/OSF.IO/G9DPN,25 https://doi.org/10.17605/OSF.IO/DKSWH26
The project contains the following reporting guidelines.
• OSF. CONSORT Checklist.
• OSF. Study Flow Diagram.
- Data is available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).
- We confirm that the article adheres to the CONSORT reporting guidelines. The clinical trial protocol, a completed CONSORT checklist, and a flow diagram have been included as extended data and will be published alongside the article. The clinical trial registration number are clearly stated in the Methods section. Additionally, any deviations from the original trial protocol have been explicitly explained in the article. The checklist has been uploaded to an online repository with a DOI, and the data is licensed under a CC 4.0 license as per the data guidelines.
We sincerely thank the participants for their invaluable contribution to this study. We also appreciate the support provided by the Faculty of Medicine, Universitas Indonesia, and Cipto Mangunkusumo Hospital (RSCM), which was crucial for the successful completion of this research.
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Are sufficient details of methods and analysis provided to allow replication by others?
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Competing Interests: No competing interests were disclosed.
Reviewer Expertise: Cardiothoracic anesthesia, cardiac surgery, echocardiography
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Version 1 26 Mar 25 |
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