Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mepivacaine Block Group | Experimental | Injection of local anesthetic (mepivacaine) above and beside the femoral artery. |
|
| Saline Sham Group | Placebo Comparator | Injection of salt water (saline) above and beside the femoral artery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mepivacaine | Drug | An ultrasound guided injection of mepivacaine superomedially to the femoral artery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Experiencing Tourniquet Hypertension | Measuring systolic blood pressure using a cuff, aim to keep <30mmHg change from baseline | Intraoperatively (~3 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Amount of Opioid Pain Medications Used by Patient |
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| William M Bullock | Assistant Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Hospital | Durham | North Carolina | 27713 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33431616 | Derived | Wahal C, Grant SA, Gadsden J, Rambhia MT, Bullock WM. Femoral artery block (FAB) attenuates thigh tourniquet-induced hypertension: a prospective randomized, double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2021 Mar;46(3):228-232. doi: 10.1136/rapm-2020-102113. Epub 2021 Jan 11. |
Not provided
Not provided
Individual participant data will not be shared; patients will be deidentified and no personal information or medical records used.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Mepivacaine Block Group | Injection of local anesthetic (mepivacaine) above and beside the femoral artery. Mepivacaine: An ultrasound guided injection of mepivacaine superomedially to the femoral artery. 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 8, 2018 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Perifemoral Injection of Local Anesthetic | 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 | Drug | An ultrasound guided injection using a medication that does NOT numb any nerves called saline, or salt water. |
|
|
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) |
| Amount of Esmolol Used Intraoperatively | Amount of esmolol (in mg) used intraoperatively to decrease blood pressure after subject achieved tourniquet hypertension. | Intraoperatively (~3 hours) |
| FG001 | Saline Sham Group | Injection of salt water (saline) above and beside the femoral artery. 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. Saline: An ultrasound guided injection using a medication that does NOT numb any nerves called saline, or salt water. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Subjects who completed the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Mepivacaine Block Group | Injection of local anesthetic (mepivacaine) above and beside the femoral artery. Mepivacaine: An ultrasound guided injection of mepivacaine superomedially to the femoral artery. 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. |
| BG001 | Saline Sham Group | Injection of salt water (saline) above and beside the femoral artery. 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. Saline: An ultrasound guided injection using a medication that does NOT numb any nerves called saline, or salt water. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||||
| ASA Status | American Society of Anesthesiologists (ASA) Physical Status Classification. ASA 1 = a normal healthy patient, ASA 2 = a patient with mild systemic disease, ASA 3 = a patient with severe systemic disease. | Count of Participants | Participants |
| |||||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects Experiencing Tourniquet Hypertension | Measuring systolic blood pressure using a cuff, aim to keep <30mmHg change from baseline | Subjects who completed the study. | Posted | Count of Participants | Participants | 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. | Subjects who completed the study. | Posted | Mean | Standard Deviation | score on a scale | 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. | Subjects who completed the study. | Posted | Mean | Standard Deviation | 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. | Subjects who completed the study. | Posted | Mean | Standard Deviation | mg | Intraoperatively (~3 hours) |
|
|
24 hours
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mepivacaine Block Group | Injection of local anesthetic (mepivacaine) above and beside the femoral artery. Mepivacaine: An ultrasound guided injection of mepivacaine superomedially to the femoral artery. 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. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG001 | Saline Sham Group | Injection of salt water (saline) above and beside the femoral artery. 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. Saline: An ultrasound guided injection using a medication that does NOT numb any nerves called saline, or salt water. | 0 | 15 | 0 | 15 | 0 | 15 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William Michael Bullock, MD, PhD | Duke University Medical Center | 919-681-6437 | william.bullock@duke.edu |
| Oct 2, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D008619 | Mepivacaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| ASA 2 |
|
| ASA 3 |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Participants |
|
|
|