Lower Extremity Regional Anesthesia and Infrainguinal Bypass Grafting

NCT01803165 | Withdrawn

• 1 other identifier: 0541-12-EP
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Peripheral Vascular Disease

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

Outcome Measures

Primary Outcomes (5)

• 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.

  up to 3 months

• 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.

  up to 3 months

• 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.

  up to 3 months

• 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.

  up to 3 months

• 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.

  up to 3 months

Secondary Outcomes (7)

• decreased length of hospital stay

  up to 1 month

• narcotic consumption

  up to 3 months

• nausea and vomiting

  up to 1 month

• post-operative cognitive dysfunction

  up to 3 months

• major cardiac events

  up to 3 months

Study Arms (2)

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

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.

Interventions

Single shot femoral and sciatic nerve block PROCEDURE

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.

Single shot femoral and sciatic nerve block

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify 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
• evidence of gross neurological dysfunction of the lower extremity

Sponsors & Collaborators

• University of Nebraska: lead

Related Publications (4)

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

  PMID: 19690276 BACKGROUND

• 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.

  PMID: 21367563 BACKGROUND

• 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.

  PMID: 15599475 BACKGROUND

• 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.

  PMID: 17000075 BACKGROUND

MeSH Terms

Conditions

Peripheral Vascular Diseases; Cognitive Dysfunction; Wound Infection; Pain, Postoperative; Arteriovenous Fistula; Thrombosis

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Vascular Fistula; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Embolism and Thrombosis

Study Officials

• Thomas A Nicholas, MD

  Univversity of Nebraska Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2013
• First Posted: March 4, 2013
• Study Start: May 1, 2013
• Primary Completion: September 10, 2013
• Study Completion: September 10, 2013
• Last Updated: August 14, 2023

Record last verified: 2023-08