Sciatic Block Increases Regional Saturation in Peripheral Artery Occlusive Disease.

Peripheral Artery Occlusive Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04341051
• Other study ID #: 0033871
• Status: Not yet recruiting
• Start date: April 1, 2020
• Est. completion date: May 31, 2020

Study information

• Verified date: April 2020
• Source: Azienda Ospedaliera Città della Salute e della Scienza di Torino
• Contact: Fabio Gobbi, Doctor
• Phone: +39 3476655128
• Email: fabiogobbi74[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 31
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Occlusive Disease
• Popliteal Sciatic Nerve Block

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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