Sciatic Block Increases Regional Saturation in Peripheral Artery Occlusive Disease.

NCT ID: NCT04341051

Last Updated: 2020-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-01

Study Completion Date

2020-05-31

Brief Summary

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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

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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.

Conditions

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Peripheral Artery Occlusive Disease Popliteal Sciatic Nerve Block

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Case

Intervention Type OTHER

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

Interventions

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Case

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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San Salvatore Hospital of L'Aquila

OTHER

Sponsor Role collaborator

A.O.U. Città della Salute e della Scienza

OTHER

Sponsor Role lead

Responsible Party

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Fabio Gobbi

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fabio Gobbi, Doctor

Role: PRINCIPAL_INVESTIGATOR

A.O.U. Città della Salute e della Scienza

Central Contacts

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Fabio Gobbi, Doctor

Role: CONTACT

+39 3476655128

Other Identifiers

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0033871

Identifier Type: -

Identifier Source: org_study_id

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