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OpenTrials
Completed

NCT Number: NCT04730310

Anesthesia Technique and Lower Limb Revascularization Patency

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).

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Key information

Conditions

Regional Anesthesia, Vascular Grafting, Vascular Patency

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

Infrainguinal, open lower extremity revascularization procedures

Primary outcomes

  1. Graft Patency

    Time frame: 30 days

    • Derived using NSQIP variables "Most Severe Procedural Outcome" LEO_MOSTSEVOUTCOME and "Untreated Loss of Patency" (i.e. not patent and no procedure done) LEO_ULP
    • Yes if LEO_MOSTSEVOUTCOME is any of
    • Clinically Patent Graft
    • Patent graft, no stenosis
    • Patent graft with stenosis
    • No if LEO_MOSTSEVOUTCOME is any of
    • Death
    • Image-proven graft thrombosis or clinically evident thrombosis with no planned intervention
    • Major Amputation
    • New bypass in the treated arterial segment
    • Not documented
    • Other
    • Revised graft with stenosis
    • Revised graft, no current stenosis
    • No if LEO_ULP = "yes"

Secondary outcomes

  1. Major reintervention

    Time frame: 30 days

    • Major reintervention, using NSQIP variable "Major Reintervention on the Bypass" defined as ""Yes" if the patient underwent a subsequent procedure (new or revision lower extremity bypass operation, jump/interposition graft revision, bypass graft thrombectomy/thrombolysis) within 30 days of the original primary operation."

  2. Amputation

    Time frame: 30 days

    • Amputation, using NSQIP variable "Major Amputation (Transtibial or Proximal)", defined as ""Yes" if the patient underwent transtibial or more proximal amputation on the ipsilateral leg within 30 days of the original primary operation."

  3. Bleeding requiring transfusion

    Time frame: 30 days

  4. Venous thromboembolism

    Time frame: 30 days

  5. MI or stroke

    Time frame: 30 days

  6. Pneumonia

    Time frame: 30 days

  7. length of postoperative hospital stay

    Time frame: 30 days

  8. Discharge destination

    Time frame: 30 days

    dichotomize as home vs. not home

  9. Readmission rate

    Time frame: 30 days

  10. death

    Time frame: 30 days or in-hospital admission

  11. Composite thromboembolism

    Time frame: 30 days

    combination of venothromboembolism, MI, stroke

  12. Composite Morbidity and Mortality

    Time frame: 30 days

    combination of bleeding requiring transfusion, venothromboembolism, MI, stroke, pneumonia, death

Other outcomes

  1. Confounders

    Time frame: day of surgery

    age, bleeding diathesis, severe COPD, total operating, time, renal failure, functional status, cardiac valvular disease, diabetes

  2. Confounders

    Time frame: day of surgery

    INR, PTT

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

Association of Anesthesia Technique With Graft Patency Rates After Open Lower Limb Revascularization: a Retrospective Population Cohort Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 29, 2021
Registry last updated
Jan 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.