Duke University Hospital
Durham, North Carolina, 27713, United States
NCT Number: NCT03390426
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.
Looking for future studies?
Notify Me18 year–75 year
All sexes
Interventional
Phase 4
Durham, North Carolina, 27713, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
An ultrasound guided injection of mepivacaine superomedially to the femoral artery.
Other names: Carbocaine
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 names: Femoral periarterial injection
An ultrasound guided injection using a medication that does NOT numb any nerves called saline, or salt water.
Other names: Salt Water placebo
Time frame: Intraoperatively (~3 hours)
Measuring systolic blood pressure using a cuff, aim to keep <30mmHg change from baseline
Time frame: While in PACU (~1 hour)
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.
Time frame: Perioperative period (~4 hours)
Amount of opioid pain medication used by patient over a 4 hour period immediately after surgery. Opioids taken are converted to morphine equivalents.
Time frame: Intraoperatively (~3 hours)
Amount of esmolol (in mg) used intraoperatively to decrease blood pressure after subject achieved tourniquet hypertension.
Duke University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04454203
Ankle Fusion, Intraoperative Hypertension
Durham, North Carolina, United States
View Trial DetailsNCT06936410
Tourniquet Hypertension
Cairo, Egypt
View Trial DetailsNCT07548567
Tourniquet Hypertension
Athens, Greece
View Trial DetailsNCT07700797
Anterior Cruciate Ligament (ACL) Tear, Knee Surgeries
Zagazig, Sharqia Province, Egypt
View Trial Details