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.

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.

Study Overview

• Status: Unknown
• Conditions: Peripheral Artery Occlusive Disease; Popliteal Sciatic Nerve Block
• Intervention / Treatment: Other: Case

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 Type: Observational
• Enrollment (Anticipated): 31

Contacts and Locations

• Study Contact: Name: Fabio Gobbi, Doctor; Phone Number: +39 3476655128; Email: fabiogobbi74@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients suffering from Peripheral Artery Occlusive Disease undergoing popliteal sciatic nerve block as analgesic procedure before revascularization surgery

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Case; Mesure with NIRS regional saturation in patients undergoing popliteal block during vascular surgery for chronic obliterating arteriopathy (IIa to III Fontaine Classification)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Regional Oxigen saturation downstream of popliteal region	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	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparing the results between AOCP IIa to III (Fontaine Classification)	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	1 day
Comparing the results between patients with occlusion of a single arthery and patients with more occluded arthery	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	1 day

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Città della Salute e della Scienza di Torino
• Collaborators: San Salvatore Hospital of L'Aquila
• Investigators: Principal Investigator: Fabio Gobbi, Doctor, Azienda Ospedaliera Città della Salute e della Scienza di Torino

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2020
• Primary Completion (Anticipated): May 31, 2020
• Study Completion (Anticipated): May 31, 2020

Study Registration Dates

• First Submitted: April 8, 2020
• First Submitted That Met QC Criteria: April 8, 2020
• First Posted (Actual): April 10, 2020

Study Record Updates

• Last Update Posted (Actual): April 10, 2020
• Last Update Submitted That Met QC Criteria: April 8, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: regional oxigen saturation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: 0033871

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No