Sciatic Block Increases Regional Saturation in Peripheral Artery Occlusive Disease.

• Conditions: Popliteal Sciatic Nerve Block; Peripheral Artery Occlusive Disease
• Interventions: Other: Case

• Registration Number: NCT04341051
• Lead Sponsor: A.O.U. Città della Salute e della Scienza

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.

Study Timeline

• Status Verified: 2020-04
• Study Start: 2020-04-01
• Study First Submitted: 2020-04-08
• Study First Submitted QC: 2020-04-08
• Last Update Submitted: 2020-04-08
• Study First Posted: 2020-04-10
• Last Update Posted: 2020-04-10
• Primary Completion: 2020-05-31
• Study Completion: 2020-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case	Case	we will observe the regional saturation of O2 through NIRS at the following time: T0(before peripheral anesthesia); T1 (5 minutes from the block); T2 (15 minutes from the block); T3 (30 minutes from the block); T4 (after revascularization); At each interval PA, SpO2 and NIRS were also recorded in the contralateral limb as control data.

Primary Outcome Measures

Name	Time	Method
Regional Oxigen saturation downstream of popliteal region	1 day	NIRS 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 Outcome Measures

Name	Time	Method
Comparing the results between patients with occlusion of a single arthery and patients with more occluded arthery	1 day	NIRS 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 AOCP IIa to III (Fontaine Classification)	1 day	NIRS 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