Anesthesia Technique and Lower Limb Revascularization Patency

NCT ID: NCT04730310

Last Updated: 2023-01-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 8893 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-03-31

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 (GA+RA), 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 (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 (GA+RA), 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.

Conditions

Regional Anesthesia, Vascular Grafting, Vascular Patency

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Regional Anesthesia (RA)

RA

• Includes spinal, epidural, peripheral nerve block, excludes local infiltration (unlikely that any major open revascularization can be done under local)
• Defined as: NSQIP Principal (ANESTHES) or additional (ANESTHES_OTHER) anesthesia technique = regional, spinal, epidural, or MAC (in NSQIP RA/Spinal/Local + MAC are coded as MAC; while this includes local + MAC, it would be unlikely that local anesthesia would be sufficient for open revascularization)

NSQIP Lower Extremity Open (LEO) procedure-targeted dataset (i.e. undergoing Lower extremity open revascularization) from 2014-2019

Intervention Type: PROCEDURE

Infrainguinal, open lower extremity revascularization procedures

General Anesthesia (GA)

GA

• Defined as: NSQIP Principal or additional anesthesia technique = general
• Since GA is selected as the principal anesthetic technique by default when multiple techniques are present, GA + RA could potentially have been coded as GA if the optional variable of additional anesthesia technique is not filled in, leading to differential misclassification of patients with GA + RA (most likely epidural and peripheral nerve block) in the GA group.

NSQIP Lower Extremity Open (LEO) procedure-targeted dataset (i.e. undergoing Lower extremity open revascularization) from 2014-2019

Intervention Type: PROCEDURE

Infrainguinal, open lower extremity revascularization procedures

Interventions

NSQIP Lower Extremity Open (LEO) procedure-targeted dataset (i.e. undergoing Lower extremity open revascularization) from 2014-2019

Infrainguinal, open lower extremity revascularization procedures

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• All elective cases within the NSQIP Lower Extremity Open (LEO) procedure-targeted dataset (i.e. undergoing Lower extremity open revascularization) from 2014-2019 will be included.
• Hybrid procedures (where patients had both open and endovascular repair) are included, as long as there is an open component.

Exclusion Criteria

• Patients will be excluded if they underwent urgent or emergency surgery (identified using NSQIP variable EMERGNCY=1 OR ELECTSURG=0)
• local was the only anesthetic technique listed in principal and additional anesthesia technique.
• missing data on exposure, procedure name, or status of elective surgery. This includes having "other" or "unknown" for BOTH principal and additional anesthesia technique
• Patients with INR >= 1.5 on day of surgery

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Christopher Prabhakar

Clinical Assistant Professor, Deparment of Anesthesiology, Pharmacology and Therapeutics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

St. Paul's Hospital

Vancouver, British Columbia, Canada

Countries

Canada

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Other Identifiers

H20-03437

Identifier Type: -

Identifier Source: org_study_id