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

Intraoperative Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03390426
• Other study ID #: Pro00089161
• Status: Completed
• Phase: Phase 4
• Start date: May 3, 2018
• Est. completion date: October 28, 2018

Study information

• Verified date: April 2021
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: October 28, 2018
• Est. primary completion date: October 27, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle Fusion
• Hypertension
• Intraoperative Hypertension
• Total Ankle Arthroplasty
• Tourniquet Hypertension

Intervention

Drug:
• Mepivacaine
An ultrasound guided injection of mepivacaine superomedially to 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.

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

Locations

Country	Name	City	State
United States	Duke University Hospital	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects Experiencing Tourniquet Hypertension	Measuring systolic blood pressure using a cuff, aim to keep <30mmHg change from baseline	Intraoperatively (~3 hours)
Secondary	Pain Scores as Measured by the Numeric Rating Scale (NRS-11)	The Numeric Rating Scale (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.	While in PACU (~1 hour)
Secondary	Amount of Opioid Pain Medications Used by Patient	Amount of opioid pain medication used by patient over a 4 hour period immediately after surgery. Opioids taken are converted to morphine equivalents.	Perioperative period (~4 hours)
Secondary	Amount of Esmolol Used Intraoperatively	Amount of esmolol (in mg) used intraoperatively to decrease blood pressure after subject achieved tourniquet hypertension.	Intraoperatively (~3 hours)