Sciatic Block Increases Regional Saturation in Peripheral Artery Occlusive Disease.
1 other identifier
observational
31
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2020
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2020
CompletedFirst Submitted
Initial submission to the registry
April 8, 2020
CompletedFirst Posted
Study publicly available on registry
April 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2020
CompletedApril 10, 2020
April 1, 2020
2 months
April 8, 2020
April 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Comparing the results between AOCP IIa to III (Fontaine Classification)
1 day
Comparing the results between patients with occlusion of a single arthery and patients with more occluded arthery
1 day
Study Arms (1)
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.
Interventions
Mesure with NIRS regional saturation in patients undergoing popliteal block during vascular surgery for chronic obliterating arteriopathy (IIa to III Fontaine Classification)
Eligibility Criteria
Patients suffering from Peripheral Artery Occlusive Disease undergoing popliteal sciatic nerve block as analgesic procedure before revascularization surgery
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Fabio Gobbi, Doctor
A.O.U. Città della Salute e della Scienza
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
April 8, 2020
First Posted
April 10, 2020
Study Start
April 1, 2020
Primary Completion
May 31, 2020
Study Completion
May 31, 2020
Last Updated
April 10, 2020
Record last verified: 2020-04