Lower Extremity Regional Anesthesia and Infrainguinal Bypass Grafting

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2013 by University of Nebraska
Sponsor:
Information provided by (Responsible Party):
Thomas Nicholas IV MD, University of Nebraska
ClinicalTrials.gov Identifier:
NCT01803165
First received: February 26, 2013
Last updated: February 28, 2013
Last verified: February 2013
  Purpose

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 Intervention
Peripheral Vascular Disease.
Procedure: Single shot femoral and sciatic nerve block

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Lower Extremity Regional Anesthesia and Infrainguinal Bypass Grafting

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • graft thrombosis [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
  • limb amputation [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
  • wound infection [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
  • graft revision [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
  • death rate [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • decreased length of hospital stay [ Time Frame: up to 1 month ] [ Designated as safety issue: No ]
    decreased length of post surgical hospital stay

  • narcotic consumption [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
    Overall narcotic consumption will be recorded

  • nausea and vomiting [ Time Frame: up to 1 month ] [ Designated as safety issue: No ]
  • post-operative cognitive dysfunction [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
  • major cardiac events [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
  • post-operative pain [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
  • hyperglycemic episodes [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: May 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Hide Detailed Description

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01803165

Contacts
Contact: Thomas A Nicholas, MD 402-957-3758 tnichola@unmc.edu

Locations
United States, Nebraska
University of Nebraska Medical Center Not yet recruiting
Omaha, Nebraska, United States, 68198-4455
Contact: Thomas A Nicholas, MD    402-957-3758    tnichola@unmc.edu   
Principal Investigator: Thomas A Nicholas, MD         
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Thomas A Nicholas, MD Univversity of Nebraska Medical Center
  More Information

Publications:
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
Study First Received: February 26, 2013
Last Updated: February 28, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University of Nebraska:
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

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014