Ignite Creation Date:
2024-05-06 @ 3:44 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04730310
Status:
COMPLETED
Last Update Posted:
2023-01-11
First Post:
2021-01-25
Brief Title:
Anesthesia Technique and Lower Limb Revascularization Patency
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Association of Anesthesia Technique With Graft Patency Rates After Open Lower Limb Revascularization a Retrospective Population Cohort Study
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The role of regional anesthesia in lower extremity revascularization procedures on reducing graft failure and need for reoperation remains unclear In this study we will analyze data from the multicenter National Surgical Quality Improvement Program ACS NSQIP to assess the association between regional anesthesia RA and graft outcomes as compared to general anesthesia GA Our primary objective is to determine for patients undergoing elective open lower limb revascularization whether RA spinal epidural and peripheral nerve block compared to GA or general anesthesia with regional anesthesia GARA is associated with higher rates of patent graft within 30 days postoperatively primary outcome
Detailed Description:
Lower limb infrainguinal revascularization surgeries are performed for patients with blood flow occlusion with the goals of improving pain and function Graft patency is associated with higher quality of life scores However open lower limb revascularization is associated with a significant risk of graft failure Multiple anesthesia options exist for elective open lower limb revascularization including general and regional spinal epidural peripheral nerve block The literature has shown mixed results regarding the superiority of regional anesthesia over general anesthesia for morbidity and mortality In this study we will analyze data from the multicenter National Surgical Quality Improvement Program ACS NSQIP to assess the association between regional anesthesia RA and graft outcomes as compared to general anesthesia GAOur primary objective is to determine for patients undergoing elective open lower limb revascularization whether RA spinal epidural and peripheral nerve block compared to GA or general anesthesia with regional anesthesia GARA is associated with higher rates of patent graft within 30 days postoperatively primary outcome Our secondary outcomes are major reintervention amputation bleeding requiring transfusion or secondary procedure venous thromboembolism VTE myocardial infarction MI or stroke pneumonia discharge destination postoperative length of stay readmission rate and death all within 30 days postoperatively There will be two composite outcomes thromboembolism and morbidity and mortality We hypothesize that the use of RA is associated with increased graft patency after elective lower limb revascularization compared to GA Compared to GA RA is associated with decreased rates of major reintervention amputation death 30 days bleeding requiring transfusion or secondary procedure VTE MI or stroke pneumonia mortality composite thromboembolism and composite morbidity and mortality Compared to GA RA is associated with increased rates of discharge destination being home
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None