Lower Extremity Regional Anesthesia and Infrainguinal Bypass Grafting - Full Text View

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:

MedlinePlus related topics: Nausea and Vomiting Peripheral Arterial Disease Vascular Diseases

U.S. FDA Resources

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.

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.

Show Detailed Description

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

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:

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

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.

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. Epub 2006 Sep 26.

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 May 23, 2013