Sciatic Block Increases Regional Saturation in Peripheral Artery Occlusive Disease.

Sponsor

Azienda Ospedaliera Città della Salute e della Scienza di Torino (Other)

Overall Status

Unknown status

CT.gov ID

NCT04341051

Collaborator

San Salvatore Hospital of L'Aquila (Other)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Artery Occlusive Disease Popliteal Sciatic Nerve Block	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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

31 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2020

Anticipated Primary Completion Date :

May 31, 2020

Anticipated Study Completion Date :

May 31, 2020

Arms and Interventions

Arm	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)

Arm

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)

Outcome Measures

Primary Outcome Measures

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

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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Azienda Ospedaliera Città della Salute e della Scienza di Torino
San Salvatore Hospital of L'Aquila

Investigators

Principal Investigator: Fabio Gobbi, Doctor, Azienda Ospedaliera Città della Salute e della Scienza di Torino

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fabio Gobbi, Doctor, Azienda Ospedaliera Città della Salute e della Scienza di Torino

ClinicalTrials.gov Identifier:

NCT04341051

Other Study ID Numbers:

0033871

First Posted:

Apr 10, 2020

Last Update Posted:

Apr 10, 2020

Last Verified:

Apr 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Fabio Gobbi, Doctor, Azienda Ospedaliera Città della Salute e della Scienza di Torino

regional oxigen saturation

Additional relevant MeSH terms:

Peripheral Arterial Disease

Study Results

No Results Posted as of Apr 10, 2020