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

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ClinicalTrials.gov Identifier: NCT03390426
Recruitment Status : Completed
First Posted : January 4, 2018
Results First Posted : October 30, 2019
Last Update Posted : October 6, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Tourniquet Hypertension Intraoperative Hypertension Total Ankle Arthroplasty Ankle Fusion Drug: Mepivacaine Procedure: Perifemoral Injection of Local Anesthetic Drug: Saline Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Femoral Peri-arterial Local Anesthetic Injection Decreases Tourniquet Associated Ischemic Hypertension
Actual Study Start Date : May 3, 2018
Actual Primary Completion Date : October 27, 2018
Actual Study Completion Date : October 28, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mepivacaine Block Group
Injection of local anesthetic (mepivacaine) above and beside the femoral artery.
Drug: Mepivacaine
An ultrasound guided injection of mepivacaine superomedially to the femoral artery.
Other Name: Carbocaine

Procedure: 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.
Other Name: Femoral periarterial injection

Placebo Comparator: Saline Sham Group
Injection of salt water (saline) above and beside the femoral artery.
Procedure: 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.
Other Name: Femoral periarterial injection

Drug: Saline
An ultrasound guided injection using a medication that does NOT numb any nerves called saline, or salt water.
Other Name: Salt Water placebo




Primary Outcome Measures :
  1. Number of Subjects Experiencing Tourniquet Hypertension [ Time Frame: Intraoperatively (~3 hours) ]
    Measuring systolic blood pressure using a cuff, aim to keep <30mmHg change from baseline


Secondary Outcome Measures :
  1. Pain Scores as Measured by the Numeric Rating Scale (NRS-11) [ Time Frame: While in PACU (~1 hour) ]
    The NRS-11 is an 11-point scale for patient self-reporting of pain. 0 = No Pain, 1-3 = Mild Pain, 4-6 = Moderate Pain, 7-10 = Severe Pain.

  2. Amount of Opioid Pain Medications Used by Patient [ Time Frame: Perioperative period (~4 hours) ]
  3. Amount of Esmolol Used Intraoperatively [ Time Frame: Intraoperatively (~3 hours) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT03390426


Locations
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United States, North Carolina
Duke University Hospital
Durham, North Carolina, United States, 27713
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: William M Bullock Assistant Professor
  Study Documents (Full-Text)

Documents provided by Duke University:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03390426    
Other Study ID Numbers: Pro00089161
First Posted: January 4, 2018    Key Record Dates
Results First Posted: October 30, 2019
Last Update Posted: October 6, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared; patients will be deidentified and no personal information or medical records used.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Duke University:
Perifemoral
Tourniquet
Mepivacaine
Tourniquet Hypertension
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Anesthetics
Mepivacaine
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents