Regional Anesthesia, Vascular Grafting, Vascular PatencyNCT04730310
Anesthesia Technique and Lower Limb Revascularization Patency
An observational study of Regional Anesthesia, Vascular Grafting, Vascular Patency, run by University of British Columbia at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Regional Anesthesia, Vascular Grafting, Vascular Patency
- What is being tested?
- NSQIP Lower Extremity Open (LEO) procedure-targeted dataset (i.e. undergoing Lower extremity open revascularization) from 2014-2019
- Type of treatment
- Surgery or procedure
- How many people
- 8,893 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2021to 31 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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. The estimated sample size is 15,000 based on the NSQIP Participant Use Files. Elective procedures will be identified using the NSQIP variable ELECTSURG=1. Urgent and emergency procedures are not included, as patients may not being offered RA due to insufficient time and/or unable to withhold anticoagulants/antiplatelets due to acute limb ischemia. Note that age 18 years and older is already part of the NSQIP inclusion criteria. Hybrid procedures (where patients had both open and endovascular repair) are included, as long as there is an open component.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of Anesthesia Technique With Graft Patency Rates After Open Lower Limb Revascularization: a Retrospective Population Cohort Study
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).
Read the 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.
- Being tested
- NSQIP Lower Extremity Open (LEO) procedure-targeted dataset (i.e. undergoing Lower extremity open revascularization) from 2014-2019
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NSQIP Lower Extremity Open (LEO) procedure-targeted dataset (i.e. undergoing Lower extremity open revascularization) from 2014-2019Procedure or surgery
Infrainguinal, open lower extremity revascularization procedures
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Procedure: NSQIP Lower Extremity Open (LEO) procedure-targeted dataset (i.e. undergoing Lower extremity open revascularization) from 2014-2019 | |
| 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. Receives: Procedure: NSQIP Lower Extremity Open (LEO) procedure-targeted dataset (i.e. undergoing Lower extremity open revascularization) from 2014-2019 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft Patency
- 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"
Measured: 30 days
Secondary outcomes (12)
Major reintervention
- 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."
Measured: 30 days
Amputation
- 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."
Measured: 30 days
Bleeding requiring transfusion
Measured: 30 days
Venous thromboembolism
Measured: 30 days
MI or stroke
Measured: 30 days
Pneumonia
Measured: 30 days
length of postoperative hospital stay
Measured: 30 days
Discharge destination
dichotomize as home vs. not home
Measured: 30 days
Readmission rate
Measured: 30 days
death
Measured: 30 days or in-hospital admission
Composite thromboembolism
combination of venothromboembolism, MI, stroke
Measured: 30 days
Composite Morbidity and Mortality
combination of bleeding requiring transfusion, venothromboembolism, MI, stroke, pneumonia, death
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start1 Feb 2021
- Primary completion28 Feb 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Regional Anesthesia, Vascular Grafting, Vascular PatencyStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 8,893 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Prabhakar, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04730310
- Sponsor's protocol ID
- H20-03437
- Status last verified
- Jan 2023
- First submitted
- 25 Jan 2021
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: NSQIP data would be free to other researchers from central site.
Publications
Barbosa FT, Juca MJ, Castro AA, Cavalcante JC. Neuraxial anaesthesia for lower-limb revascularization. Cochrane Database Syst Rev. 2013 Jul 29;2013(7):CD007083. doi: 10.1002/14651858.CD007083.pub3.
PubMed 23897485Nguyen LL, Moneta GL, Conte MS, Bandyk DF, Clowes AW, Seely BL; PREVENT III Investigators. Prospective multicenter study of quality of life before and after lower extremity vein bypass in 1404 patients with critical limb ischemia. J Vasc Surg. 2006 Nov;44(5):977-83; discussion 983-4. doi: 10.1016/j.jvs.2006.07.015.
PubMed 17098529Grip O, Wanhainen A, Michaelsson K, Lindhagen L, Bjorck M. Open or endovascular revascularization in the treatment of acute lower limb ischaemia. Br J Surg. 2018 Nov;105(12):1598-1606. doi: 10.1002/bjs.10954. Epub 2018 Jul 25.
PubMed 30043994Ghanami RJ, Hurie J, Andrews JS, Harrington RN, Corriere MA, Goodney PP, Hansen KJ, Edwards MS. Anesthesia-based evaluation of outcomes of lower-extremity vascular bypass procedures. Ann Vasc Surg. 2013 Feb;27(2):199-207. doi: 10.1016/j.avsg.2012.04.006. Epub 2012 Sep 1.
PubMed 22944010Sgroi MD, McFarland G, Mell MW. Utilization of regional versus general anesthesia and its impact on lower extremity bypass outcomes. J Vasc Surg. 2019 Jun;69(6):1874-1879. doi: 10.1016/j.jvs.2018.08.190. Epub 2019 Feb 18.
PubMed 30792062Fereydooni A, O'Meara T, Popescu WM, Dardik A, Ochoa Chaar CI. Utilization and Outcomes of Local Anesthesia and Peripheral Nerve Block for Hybrid Lower Extremity Revascularization. J Endovasc Ther. 2020 Feb;27(1):94-101. doi: 10.1177/1526602819887382. Epub 2019 Nov 20.
PubMed 31746264Roberts DJ, Nagpal SK, Kubelik D, Brandys T, Stelfox HT, Lalu MM, Forster AJ, McCartney CJ, McIsaac DI. Association between neuraxial anaesthesia or general anaesthesia for lower limb revascularisation surgery in adults and clinical outcomes: population based comparative effectiveness study. BMJ. 2020 Nov 25;371:m4104. doi: 10.1136/bmj.m4104.
PubMed 33239330Christopherson R, Beattie C, Frank SM, Norris EJ, Meinert CL, Gottlieb SO, Yates H, Rock P, Parker SD, Perler BA, et al. Perioperative morbidity in patients randomized to epidural or general anesthesia for lower extremity vascular surgery. Perioperative Ischemia Randomized Anesthesia Trial Study Group. Anesthesiology. 1993 Sep;79(3):422-34. doi: 10.1097/00000542-199309000-00004.
PubMed 8363066Wiis JT, Jensen-Gadegaard P, Altintas U, Seidelin C, Martusevicius R, Mantoni T. One-week postoperative patency of lower extremity in situ bypass graft comparing epidural and general anesthesia: retrospective study of 822 patients. Ann Vasc Surg. 2014 Feb;28(2):295-300. doi: 10.1016/j.avsg.2013.01.027. Epub 2013 Sep 29.
PubMed 24084268Jorgensen MS, Farres H, James BLW, Li Z, Almerey T, Sheikh-Ali R, Clendenen S, Robards C, Erben Y, Oldenburg WA, Hakaim AG. The Role of Regional versus General Anesthesia on Arteriovenous Fistula and Graft Outcomes: A Single-Institution Experience and Literature Review. Ann Vasc Surg. 2020 Jan;62:287-294. doi: 10.1016/j.avsg.2019.05.016. Epub 2019 Aug 2.
PubMed 31382001Gao C, Weng C, He C, Xu J, Yu L. Comparison of regional and local anesthesia for arteriovenous fistula creation in end-stage renal disease: a systematic review and meta-analysis. BMC Anesthesiol. 2020 Aug 31;20(1):219. doi: 10.1186/s12871-020-01136-1.
PubMed 32867692Goodney PP, Nolan BW, Schanzer A, Eldrup-Jorgensen J, Bertges DJ, Stanley AC, Stone DH, Walsh DB, Powell RJ, Likosky DS, Cronenwett JL; Vascular Study Group of Northern New England. Factors associated with amputation or graft occlusion one year after lower extremity bypass in northern New England. Ann Vasc Surg. 2010 Jan;24(1):57-68. doi: 10.1016/j.avsg.2009.06.015. Epub 2009 Sep 11.
PubMed 19748222Levey AS, Stevens LA, Schmid CH, Zhang YL, Castro AF 3rd, Feldman HI, Kusek JW, Eggers P, Van Lente F, Greene T, Coresh J; CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration). A new equation to estimate glomerular filtration rate. Ann Intern Med. 2009 May 5;150(9):604-12. doi: 10.7326/0003-4819-150-9-200905050-00006.
PubMed 19414839
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Anesthesia Technique With Graft Patency Rates After Open Lower Limb Revascularization: a Retrospective Population Cohort Study
- ClinicalTrials.gov ID
- NCT04730310
- Acronym / sponsor ID
- H20-03437
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,893 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 29 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regional Anesthesia (RA) | – | Procedure: NSQIP Lower Extremity Open (LEO) procedure-targeted dataset (i.e. undergoing Lower extremity open revascularization) from 2014-2019RA * 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) |
| General Anesthesia (GA) | – | Procedure: NSQIP Lower Extremity Open (LEO) procedure-targeted dataset (i.e. undergoing Lower extremity open revascularization) from 2014-2019GA * 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. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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. The estimated sample size is 15,000 based on the NSQIP Participant Use Files. Elective procedures will be identified using the NSQIP variable ELECTSURG=1. Urgent and emergency procedures are not included, as patients may not being offered RA due to insufficient time and/or unable to withhold anticoagulants/antiplatelets due to acute limb ischemia. Note that age 18 years and older is already part of the NSQIP inclusion criteria. Hybrid procedures (where patients had both open and endovascular repair) are included, as long as there is an open component.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NSQIP Lower Extremity Open (LEO) procedure-targeted dataset (i.e. undergoing Lower extremity open revascularization) from 2014-2019Infrainguinal, open lower extremity revascularization procedures | Procedure or surgery | General Anesthesia (GA), Regional Anesthesia (RA) |
Primary outcome
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"
12 secondary outcomes
Major reintervention
Time frame: 30 days
Amputation
Time frame: 30 days
Bleeding requiring transfusion
Time frame: 30 days
Venous thromboembolism
Time frame: 30 days
MI or stroke
Time frame: 30 days
Pneumonia
Time frame: 30 days
length of postoperative hospital stay
Time frame: 30 days
Discharge destination
Time frame: 30 days
Readmission rate
Time frame: 30 days
death
Time frame: 30 days or in-hospital admission
Composite thromboembolism
Time frame: 30 days
Composite Morbidity and Mortality
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Background: PubMed 23897485Barbosa FT, Juca MJ, Castro AA, Cavalcante JC. Neuraxial anaesthesia for lower-limb revascularization. Cochrane Database Syst Rev. 2013 Jul 29;2013(7):CD007083. doi: 10.1002/14651858.CD007083.pub3.
- Background: PubMed 17098529Nguyen LL, Moneta GL, Conte MS, Bandyk DF, Clowes AW, Seely BL; PREVENT III Investigators. Prospective multicenter study of quality of life before and after lower extremity vein bypass in 1404 patients with critical limb ischemia. J Vasc Surg. 2006 Nov;44(5):977-83; discussion 983-4. doi: 10.1016/j.jvs.2006.07.015.
- Background: PubMed 30043994Grip O, Wanhainen A, Michaelsson K, Lindhagen L, Bjorck M. Open or endovascular revascularization in the treatment of acute lower limb ischaemia. Br J Surg. 2018 Nov;105(12):1598-1606. doi: 10.1002/bjs.10954. Epub 2018 Jul 25.
- Background: PubMed 22944010Ghanami RJ, Hurie J, Andrews JS, Harrington RN, Corriere MA, Goodney PP, Hansen KJ, Edwards MS. Anesthesia-based evaluation of outcomes of lower-extremity vascular bypass procedures. Ann Vasc Surg. 2013 Feb;27(2):199-207. doi: 10.1016/j.avsg.2012.04.006. Epub 2012 Sep 1.
- Background: PubMed 30792062Sgroi MD, McFarland G, Mell MW. Utilization of regional versus general anesthesia and its impact on lower extremity bypass outcomes. J Vasc Surg. 2019 Jun;69(6):1874-1879. doi: 10.1016/j.jvs.2018.08.190. Epub 2019 Feb 18.
- Background: PubMed 31746264Fereydooni A, O'Meara T, Popescu WM, Dardik A, Ochoa Chaar CI. Utilization and Outcomes of Local Anesthesia and Peripheral Nerve Block for Hybrid Lower Extremity Revascularization. J Endovasc Ther. 2020 Feb;27(1):94-101. doi: 10.1177/1526602819887382. Epub 2019 Nov 20.
- Background: PubMed 33239330Roberts DJ, Nagpal SK, Kubelik D, Brandys T, Stelfox HT, Lalu MM, Forster AJ, McCartney CJ, McIsaac DI. Association between neuraxial anaesthesia or general anaesthesia for lower limb revascularisation surgery in adults and clinical outcomes: population based comparative effectiveness study. BMJ. 2020 Nov 25;371:m4104. doi: 10.1136/bmj.m4104.
- Background: PubMed 8363066Christopherson R, Beattie C, Frank SM, Norris EJ, Meinert CL, Gottlieb SO, Yates H, Rock P, Parker SD, Perler BA, et al. Perioperative morbidity in patients randomized to epidural or general anesthesia for lower extremity vascular surgery. Perioperative Ischemia Randomized Anesthesia Trial Study Group. Anesthesiology. 1993 Sep;79(3):422-34. doi: 10.1097/00000542-199309000-00004.
- Background: PubMed 24084268Wiis JT, Jensen-Gadegaard P, Altintas U, Seidelin C, Martusevicius R, Mantoni T. One-week postoperative patency of lower extremity in situ bypass graft comparing epidural and general anesthesia: retrospective study of 822 patients. Ann Vasc Surg. 2014 Feb;28(2):295-300. doi: 10.1016/j.avsg.2013.01.027. Epub 2013 Sep 29.
- Background: PubMed 31382001Jorgensen MS, Farres H, James BLW, Li Z, Almerey T, Sheikh-Ali R, Clendenen S, Robards C, Erben Y, Oldenburg WA, Hakaim AG. The Role of Regional versus General Anesthesia on Arteriovenous Fistula and Graft Outcomes: A Single-Institution Experience and Literature Review. Ann Vasc Surg. 2020 Jan;62:287-294. doi: 10.1016/j.avsg.2019.05.016. Epub 2019 Aug 2.
- Background: PubMed 32867692Gao C, Weng C, He C, Xu J, Yu L. Comparison of regional and local anesthesia for arteriovenous fistula creation in end-stage renal disease: a systematic review and meta-analysis. BMC Anesthesiol. 2020 Aug 31;20(1):219. doi: 10.1186/s12871-020-01136-1.
- Background: PubMed 19748222Goodney PP, Nolan BW, Schanzer A, Eldrup-Jorgensen J, Bertges DJ, Stanley AC, Stone DH, Walsh DB, Powell RJ, Likosky DS, Cronenwett JL; Vascular Study Group of Northern New England. Factors associated with amputation or graft occlusion one year after lower extremity bypass in northern New England. Ann Vasc Surg. 2010 Jan;24(1):57-68. doi: 10.1016/j.avsg.2009.06.015. Epub 2009 Sep 11.
- Individual participant dataSharing planned: No. NSQIP data would be free to other researchers from central site.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Regional Anesthesia, Vascular Grafting, Vascular Patency, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft Patency (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04730310, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023.