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Lower Extremity Regional Anesthesia and Infrainguinal Bypass Grafting

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ClinicalTrials.gov Identifier: NCT01803165
Recruitment Status : Withdrawn (Inadequate patient population)
First Posted : March 4, 2013
Last Update Posted : September 25, 2017
Information provided by (Responsible Party):

Study Description
Brief 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 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.

Condition or disease Intervention/treatment
Peripheral Vascular Disease Procedure: Single shot femoral and sciatic nerve block

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Study Design

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Lower Extremity Regional Anesthesia and Infrainguinal Bypass Grafting
Study Start Date : May 2013
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Single shot femoral and sciatic nerve block
Prospective patient study group who present for infrainguinal bypass grafting and will receive single shot femoral and sub gluteal sciatic nerve blocks.
Procedure: Single shot femoral and sciatic nerve block
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.
Retrospective study group
Retrospective 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.

Outcome Measures

Primary Outcome Measures :
  1. graft thrombosis [ Time Frame: up to 3 months ]
  2. limb amputation [ Time Frame: up to 3 months ]
  3. wound infection [ Time Frame: up to 3 months ]
  4. graft revision [ Time Frame: up to 3 months ]
  5. death rate [ Time Frame: up to 3 months ]

Secondary Outcome Measures :
  1. decreased length of hospital stay [ Time Frame: up to 1 month ]
    decreased length of post surgical hospital stay

  2. narcotic consumption [ Time Frame: up to 3 months ]
    Overall narcotic consumption will be recorded

  3. nausea and vomiting [ Time Frame: up to 1 month ]
  4. post-operative cognitive dysfunction [ Time Frame: up to 3 months ]
  5. major cardiac events [ Time Frame: up to 3 months ]
  6. post-operative pain [ Time Frame: up to 3 months ]
  7. hyperglycemic episodes [ Time Frame: up to 3 months ]

Eligibility Criteria

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients 19 years of age and older who are candidates to undergo infrainguinal bypass grafting for the treatment of peripheral vascular disease.

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01803165

United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-4455
Sponsors and Collaborators
University of Nebraska
Principal Investigator: Thomas A Nicholas, MD Univversity of Nebraska Medical Center
More Information

Responsible Party: Thomas Nicholas IV MD, Assistant Professor, University of Nebraska
ClinicalTrials.gov Identifier: NCT01803165     History of Changes
Other Study ID Numbers: 541-12-EP
First Posted: March 4, 2013    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017

Keywords provided by Thomas Nicholas IV MD, University of Nebraska:
emesis,post operative.
cognitive dysfunction, post operative.
wound infection, post operative.
pain, post operative.
Anesthesia, Conduction/methods
Arteriovenous Shunt, Surgical/adverse effects
Regional Blood Flow/drug effects
Risk Factors
Treatment Outcome
Vascular Surgical Procedures/methods
Vasodilation/drug effects

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Arterial Occlusive Diseases
Central Nervous System Depressants
Physiological Effects of Drugs