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

Arm | Intervention/treatment |
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Experimental: Mepivacaine Block Group
Injection of local anesthetic (mepivacaine) above and beside the femoral artery.
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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.
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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 |
- 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
- 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.
- Amount of Opioid Pain Medications Used by Patient [ Time Frame: Perioperative period (~4 hours) ]
- Amount of Esmolol Used Intraoperatively [ Time Frame: Intraoperatively (~3 hours) ]

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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 |
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:
- ASA 4 or 5
- Diagnosis of chronic pain
- Daily chronic opioid use (over 3 months of continuous opioid use).
- Inability to communicate pain scores or need for analgesia.
- Infection at the site of block placement
- Age under 18 years old or greater than 75 years old
- Pregnant women (as determined by standard of care day-of surgery urine bHCG)
- Intolerance/allergy to local anesthetics
- Weight <50 kg
- Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
- Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance.
- 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

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
United States, North Carolina | |
Duke University Hospital | |
Durham, North Carolina, United States, 27713 |
Principal Investigator: | William M Bullock | Assistant Professor |
Documents provided by Duke University:
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. |
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 |
Perifemoral Tourniquet Mepivacaine Tourniquet Hypertension |
Hypertension Vascular Diseases Cardiovascular Diseases Anesthetics Mepivacaine |
Anesthetics, Local Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |