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Peripheral Vascular DiseaseNCT01803165

Lower Extremity Regional Anesthesia and Infrainguinal Bypass Grafting

An observational study of Peripheral Vascular Disease, run by University of Nebraska.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

In this investigation, the investigators will attempt to demonstrate that patients who have received nerve blocks (regional anesthesia) prior to open surgical vascular bypass of the lower extremities (infrainguinal bypass grafting) will have improved surgical outcomes namely a reduction in the rates of death, wound… Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Peripheral Vascular Disease
What is being tested?
Single shot femoral and sciatic nerve block
How many people
0 participants
Where
No sites listed yet
Study dates
May 2013to 10 Sep 2013
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients 19 years of age and older who are candidates to undergo infrainguinal bypass grafting for the treatment of peripheral vascular disease.

Who may be able to join

  • Patients 19 years of age and older who are candidates to undergo infrainguinal bypass grafting for the treatment of peripheral vascular disease

Who cannot join

  • age is less than 19 years
  • allergies to amide anesthetics
  • inability to undergo general anesthesia
  • acute limb ischemia
  • any existence of contraindications to regional anesthesia in the presence of antiplatelet or anticoagulative drugs
  • evidence of gross neurological dysfunction of the lower extremity

About this study

In this investigation, the investigators will attempt to demonstrate that patients who have received nerve blocks (regional anesthesia) prior to open surgical vascular bypass of the lower extremities (infrainguinal bypass grafting) will have improved surgical outcomes namely a reduction in the rates of death, wound infection, graft thrombosis, graft revision, and amputation. As well, the investigators anticipate that patients who have undergone regional anesthesia for infrainguinal bypass grafting will have improved secondary outcomes with respect to a decreased length of stay, narcotic consumption, nausea and vomiting, post-operative cognitive dysfunction, major cardiac events, post-operative pain, and hyperglycemic episodes.

Read the detailed description

Background The post-operative benefits of regional anesthesia have been described in patients undergoing vascular access surgery(1, 2). Some of the benefits that have been identified are improved vascular flow, decreased thrombosis rates, and early maturation of grafts(2). It is speculated that these benefits can be mainly attributed to sympathetic blockade by regional anesthesia. Recent literature review has not identified any prior studies which have attempted to prospectively identify if there are improved surgical outcomes in patients undergoing revascularization surgery when regional anesthesia is utilized. However, Kashyap et al. reported that regional anesthesia may decrease the incidence of perioperative thrombosis in patients who had undergone infra-popliteal revascularization surgery over a 20 year period(3). In this investigation we will attempt to ascertain whether or not there will be improved surgical outcomes namely a reduction in the rates of death, wound infection, graft thrombosis, graft revision, and amputation. As well, we anticipate that patients who have undergone regional anesthesia for infrainguinal bypass grafting will have improved secondary outcomes with respect to a decreased length of stay, narcotic consumption, nausea and vomiting, post-operative cognitive dysfunction, major cardiac events, post-operative pain, and hyperglycemic episodes.

Methods After Investigational Review Board approval, written informed consent will be obtained from 20 patients undergoing fem-popliteal bypass surgery at University of Nebraska Medical Center and enrolled in our prospective cohort registry. Patients will be excluded from the study if age is less than 19 years, allergies to amide anesthetics, inability to undergo general anesthesia, acute limb ischemia, any existence of contraindications to regional anesthesia in the presence of antiplatelet or anticoagulative drugs, or evidence of gross neurological dysfunction of the lower extremity. Baseline health data of the patient will be recorded. Ultrasound will be performed with a linear 10- to 13-Megahertz probe while performing the nerve block. Standard American Society of Anesthesiology monitors will be applied and the patient sedated at the discretion of the anesthetic team. Complications such as vascular puncture, pain on injection, or systemic toxicity will be recorded. A perineural dosing regimen for the regional blocks will be as follows: (femoral block) 20cc of 0.5% ropivicaine and (sub-gluteal posterior sciatic block) 20cc of 0.2% ropivicaine. Epinephrine will be withheld from the local anesthetic in order to prevent the potential of further ischemic complications. The patient will then undergo general anesthesia at the discretion of the anesthetic team. Any anesthetic or surgical complication will be recorded during the OR interval. The type of graft utilized and specific location of arterial intervention will be recorded.

Following surgery, the patient will be monitored and data recorded daily while the patient is recovering in the hospital. Primary outcomes which will be recorded include: death, wound infection, graft thrombosis, graft revision, and amputation. Secondary outcomes which will be recorded are pain scores, nausea and vomiting, 24 hour narcotic consumption, graft failure (defined as any occlusion requiring return to operating room), any related return to the OR for the index procedure, any major adverse cardiac events (MACE), administration of warfarin or antiplatelet medications, average 24 hour blood sugar, creatinine levels, postoperative cognitive dysfunction, and requirement of supplemental oxygen upon discharge from the PACU. As well, the patient will be queried for resumption of tobacco products. The patient's length of hospital stay will be recorded.

On discharge there will be continued surveillance for the following primary outcomes: death, wound infection, graft thrombosis, graft revision, and amputation. The secondary outcomes which will be recorded are as follows: presence of pain at rest, pain on ambulation, continued administration of anticoagulants or antiplatelets, graft failure (defined as any occlusion requiring return to operating room), any related return to the OR for the index procedure, any major adverse cardiac events (MACE), average 24 hour blood sugar, creatinine levels, and all ankle brachial pressure index (ABPI) and doppler ultrasound reports will be recorded. Also, patients will be queried for resumption of tobacco products. These observations will be recorded on post-operative day 7, 31, and 93.

A comparison group of patients (N=20) who have undergone infra-inguinal bypass grafting will be obtained from retrospective chart review. Patients who have undergone regional or neuroaxial anesthesia for their bypass procedure will be excluded. As well, patients will be matched to their cohorts by age, sex, health comorbidities including: Congestive heart failure, smoking, diabetes, and renal dysfunction, and chronic anticoagulants or antiplatelet medication administration. The same primary and secondary outcome data obtained in the prospective portion of this study will be sought and recorded by chart review.

Conclusion Improved vascular surgical outcomes have been described in patients receiving regional anesthesia and neuroaxial anesthesia(2-4). Specifically, we anticipate a decrease in overall rates of death, wound infection, graft thrombosis, graft revision, and amputation in patients receiving regional anesthesia for infra-inguinal bypass grafting. As well, we hypothesize that patients receiving regional anesthestics will have improved secondary outcomes including decreased length of stay, narcotic consumption, nausea and vomiting, post-operative cognitive dysfunction, cardiac events, post-operative pain, and hyperglycemic episodes.

Being tested
Single shot femoral and sciatic nerve block
Keywords
emesis,post operative., cognitive dysfunction, post operative., wound infection, post operative., pain, post operative., Anesthesia, Conduction/methods, Anesthesiology/methods, Arteriovenous Shunt, Surgical/adverse effects, Regional Blood Flow/drug effects, Risk Factors, Thrombosis, Treatment Outcome, Vascular Surgical Procedures/methods, Vasodilation/drug effects
Medical subject headings
Peripheral Vascular Diseases, Cognitive Dysfunction, Wound Infection, Pain, Postoperative, Arteriovenous Fistula, Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Single shot femoral and sciatic nerve blockProcedure or surgery

    Ultrasound will be performed with a linear 10- to 13-Megahertz probe while performing the nerve block. Standard American Society of Anesthesiology monitors will be applied and the patient sedated at the discretion of the anesthetic team. Complications such as vascular puncture, pain on injection, or systemic toxicity will be recorded. A perineural dosing regimen for the regional blocks will be as follows: (femoral block) 20cc of 0.5% ropivicaine and (sub-gluteal posterior sciatic block) 20cc of 0.2% ropivicaine. Epinephrine will be withheld from the local anesthetic in order to prevent the potential of further ischemic complications.

Study groups in NCT01803165
Study groupRoleWhat they receive
Single shot femoral and sciatic nerve blockProspective patient study group who present for infrainguinal bypass grafting and will receive single shot femoral and sub gluteal sciatic nerve blocks.
Receives: Procedure: Single shot femoral and sciatic nerve block
Retrospective study groupRetrospective chart review will be performed and data collected on patients who have undergone infrainguinal bypass grafting under general anesthesia and without the use of regional or neuraxial anesthesia.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. graft thrombosis

    Following surgery, the patient will be monitored and data recorded daily while the patient is recovering in the hospital for thrombosis, the predominant mechanism of early graft failure. This continues post-discharge.

    Measured: up to 3 months

  2. limb amputation

    Following surgery, the patient will be monitored and data recorded daily while the patient is recovering in the hospital for the need for limb amputation. This continues post-discharge.

    Measured: up to 3 months

  3. wound infection

    Following surgery, the patient will be monitored and data recorded daily while the patient is recovering in the hospital for wound infection. This continues post-discharge.

    Measured: up to 3 months

  4. graft revision

    Following surgery, the patient will be monitored and data recorded daily while the patient is recovering in the hospital for the need for graft revision. This continues post-discharge.

    Measured: up to 3 months

  5. death rate

    Following surgery, the patient will be monitored and data recorded daily while the patient is recovering in the hospital for expiration. This continues post-discharge.

    Measured: up to 3 months

Secondary outcomes (7)
  1. decreased length of hospital stay

    decreased length of post surgical hospital stay

    Measured: up to 1 month

  2. narcotic consumption

    Overall narcotic consumption will be recorded

    Measured: up to 3 months

  3. nausea and vomiting

    Following surgery, the patient will be monitored and data recorded daily while the patient is recovering in the hospital for nausea and vomiting. This continues post-discharge.

    Measured: up to 1 month

  4. post-operative cognitive dysfunction

    Following surgery, the patient will be monitored and data recorded daily while the patient is recovering in the hospital for cognitive dysfunction. This continues post-discharge.

    Measured: up to 3 months

  5. major cardiac events

    Following surgery, the patient will be monitored and data recorded daily while the patient is recovering in the hospital for major cardiac events. This continues post-discharge.

    Measured: up to 3 months

  6. post-operative pain

    Following surgery, the patient will be monitored and data recorded daily while the patient is recovering in the hospital for post-operative pain. This continues post-discharge.

    Measured: up to 3 months

  7. hyperglycemic episodes

    Following surgery, the patient will be monitored and data recorded daily while the patient is recovering in the hospital for hyperglycemic episodes. This continues post-discharge.

    Measured: up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2013 (estimated)
  2. Study startMay 2013 (estimated)
  3. Primary completion10 Sep 2013
  4. Study completion10 Sep 2013

Why it stopped: Inadequate patient population

Resources

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
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01803165
Sponsor's protocol ID
0541-12-EP
Status last verified
Aug 2023
First submitted
26 Feb 2013
Last updated
14 Aug 2023
Results posted
No
Data monitoring committee
No

Publications

  • Malinzak EB, Gan TJ. Regional anesthesia for vascular access surgery. Anesth Analg. 2009 Sep;109(3):976-80. doi: 10.1213/ane.0b013e3181adc208.

    PubMed 19690276
  • Sahin L, Gul R, Mizrak A, Deniz H, Sahin M, Koruk S, Cesur M, Goksu S. Ultrasound-guided infraclavicular brachial plexus block enhances postoperative blood flow in arteriovenous fistulas. J Vasc Surg. 2011 Sep;54(3):749-53. doi: 10.1016/j.jvs.2010.12.045. Epub 2011 Mar 2.

    PubMed 21367563
  • Kashyap VS, Ahn SS, Quinones-Baldrich WJ, Choi BU, Dorey F, Reil TD, Freischlag JA, Moore WS. Infrapopliteal-lower extremity revascularization with prosthetic conduit: a 20-year experience. Vasc Endovascular Surg. 2002 Jul-Aug;36(4):255-62. doi: 10.1177/153857440203600402.

    PubMed 15599475
  • Singh N, Sidawy AN, Dezee K, Neville RF, Weiswasser J, Arora S, Aidinian G, Abularrage C, Adams E, Khuri S, Henderson WG. The effects of the type of anesthesia on outcomes of lower extremity infrainguinal bypass. J Vasc Surg. 2006 Nov;44(5):964-8; discussion 968-70. doi: 10.1016/j.jvs.2006.06.035. Epub 2006 Sep 26.

    PubMed 17000075

Questions about this trial

What is this clinical trial studying?

An observational study of Peripheral Vascular Disease, run by University of Nebraska.

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 1 inclusion and 6 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: withdrawn, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

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 was withdrawn before enrolling participants, so there are no results.

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 thrombosis (time frame: up to 3 months). The study lists 5 primary outcomes in all. 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 NCT01803165, which also lists 4 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 14 Aug 2023.

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