Femoral Peri-arterial Local Anesthetic Injection Decreases Tourniquet Associated Ischemic Hypertension

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-03

Study Completion Date

2018-10-28

Brief Summary

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The purpose of this prospective randomized double-blind study is to determine if the novel technique of ultrasound guided peri-arterial injection of local anesthetic around the femoral artery decreases ischemic hypertension associated with prolonged lower extremity tourniquet time during total ankle arthroplasty (TAA) and foot fusion surgeries. Patients will be randomized 1:1 to receive either local anesthetic or saline, which will be injected superomedially to the femoral artery in an attempt to block sympathetic afferents and decrease tourniquet associated hypertension intraoperatively.

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Detailed Description

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The purpose of this prospective randomized double-blind study is to determine if the novel technique of ultrasound guided peri-arterial injection of local anesthetic around the femoral artery decreases ischemic hypertension associated with prolonged lower extremity tourniquet time during total ankle arthroplasty (TAA) and foot fusion surgeries. Efficacy will be determined by analyzing incidence of intraoperative ischemic hypertension, defined as \>30% increase in systolic blood pressure, associated with tourniquet inflation times greater than 90 minutes. The study will involve a total of 30 patients (15 in each group) and with a power of 80% to detect a 50% difference. The patients involved in the study will be ASA 1-3 patients who are undergoing either TAA or foot fusion surgeries. Patients will receive standard of care for their anesthesia, which at Duke Hospital includes placement of popliteal and saphenous perineural catheters and a general anesthetic with a laryngeal mask airway. Patients will be randomized to receive femoral peri-arterial injection with either 1.5% mepivacaine with 1:400,000 epinephrine or 0.9% saline which will be performed preoperatively at time of perineural catheter placement. Patients will assume standard risk associated with nerve blocks, including theoretical risk of nerve damage and local anesthetic systemic toxicity. Possible benefits include improved intraoperative hemodynamic stability, decreased intraoperative opioid and antihypertensive medications, and decreased tourniquet associated pain post-operatively.

Conditions

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Tourniquet Hypertension Intraoperative Hypertension Total Ankle Arthroplasty Ankle Fusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Mepivacaine Block Group

Injection of local anesthetic (mepivacaine) above and beside the femoral artery.

Group Type EXPERIMENTAL

Mepivacaine

Intervention Type DRUG

An ultrasound guided injection of mepivacaine superomedially to the femoral artery.

Perifemoral Injection of Local Anesthetic

Intervention Type PROCEDURE

An ultrasound guided injection of mepivacaine superomedially to the formal artery in an effort to numb the nerves that contribute to tourniquet hypertension intraoperatively.

Saline Sham Group

Injection of salt water (saline) above and beside the femoral artery.

Group Type PLACEBO_COMPARATOR

Perifemoral Injection of Local Anesthetic

Intervention Type PROCEDURE

An ultrasound guided injection of mepivacaine superomedially to the formal artery in an effort to numb the nerves that contribute to tourniquet hypertension intraoperatively.

Saline

Intervention Type DRUG

An ultrasound guided injection using a medication that does NOT numb any nerves called saline, or salt water.

Interventions

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Mepivacaine

An ultrasound guided injection of mepivacaine superomedially to the femoral artery.

Intervention Type DRUG

Perifemoral Injection of Local Anesthetic

An ultrasound guided injection of mepivacaine superomedially to the formal artery in an effort to numb the nerves that contribute to tourniquet hypertension intraoperatively.

Intervention Type PROCEDURE

Saline

An ultrasound guided injection using a medication that does NOT numb any nerves called saline, or salt water.

Intervention Type DRUG

Other Intervention Names

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Carbocaine Femoral periarterial injection Salt Water placebo

Eligibility Criteria

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Inclusion Criteria

Patients that will be included in the study are English speaking 18-75 year old ASA 1-3 patients undergoing total ankle arthroplasty.

Exclusion Criteria

1. ASA 4 or 5
2. Diagnosis of chronic pain
3. Daily chronic opioid use (over 3 months of continuous opioid use).
4. Inability to communicate pain scores or need for analgesia.
5. Infection at the site of block placement
6. Age under 18 years old or greater than 75 years old
7. Pregnant women (as determined by standard of care day-of surgery urine bHCG)
8. Intolerance/allergy to local anesthetics
9. Weight \<50 kg
10. Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
11. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance.
12. Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes