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Sciatic Block Increases Regional Saturation in Peripheral Artery Occlusive Disease.

Sciatic Block Increases Regional Saturation in Peripheral Artery Occlusive Disease Monitored by NIRS: a Prospective Monocentric Study.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04341051
Enrollment
31
Registered
2020-04-10
Start date
2020-04-01
Completion date
2020-05-31
Last updated
2020-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Artery Occlusive Disease, Popliteal Sciatic Nerve Block

Keywords

regional oxigen saturation

Brief summary

We conducted Single-center prospective observational study to evaluate the improvement of peripheral vascular perfusion monitored with near-infrared spectroscopy, in patients undergoing endovascular surgery after performing sciatic nervous block.

Detailed description

The aims of that study is to check regional oxigen saturation variability in patients suffering from Peripheral Artery Occlusive Disease (IIa to III Fontaine classification) undergoing popliteal sciatic nerve block as analgesic procedure before vascular surgery. We want to evaluate the increase in regional microcirculation after the popliteal nerve blocks due to vasoplegic response and vasodilatation after performing regional anaesthesia. We will place NIRS electrode on the instep of the foot to evaluate regional oxigen saturation in the interested leg before the performing of popliteal sciatic nerve block and then during the surgery (after 5 minuts, 15 minuts, 30 minuts), and after the end of the procedure.

Interventions

OTHERCase

Mesure with NIRS regional saturation in patients undergoing popliteal block during vascular surgery for chronic obliterating arteriopathy (IIa to III Fontaine Classification)

Sponsors

San Salvatore Hospital of L'Aquila
CollaboratorOTHER
A.O.U. Città della Salute e della Scienza
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* age: \> 18 years * Peripheral artery occlusive desease involving popliteal, tibial and/or peroneal artery * Stadiation IIa to III in Fontaine classification * Eligibility for PTA or Stenting

Exclusion criteria

* trophic alteration of the application site of the NIRS * less than 18 years * Pregnancy * need of sedation during the procedure * revascularization performed as emergency surgery * Allergic reactions with local anaesthetic * Previous surgery involving the interested artery

Design outcomes

Primary

MeasureTime frameDescription
Regional Oxigen saturation downstream of popliteal region1 dayNIRS misuration of delivered oxigen T0)before the execution of sciatic popliteal block T1) after 5 minuts, T2)15 minuts, T3)30 minuts, T4)after the revascularization

Secondary

MeasureTime frameDescription
Comparing the results between AOCP IIa to III (Fontaine Classification)1 dayNIRS misuration of delivered oxigen T0)before the execution of sciatic popliteal block T1) after 5 minuts, T2)15 minuts, T3)30 minuts, T4)after the revascularization
Comparing the results between patients with occlusion of a single arthery and patients with more occluded arthery1 dayNIRS misuration of delivered oxigen T0)before the execution of sciatic popliteal block T1) after 5 minuts, T2)15 minuts, T3)30 minuts, T4)after the revascularization

Contacts

Primary ContactFabio Gobbi, Doctor
fabiogobbi74@gmail.com+39 3476655128

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026