Tourniquet HypertensionPhase 4NCT04454203
Femoral Peri-arterial Local Anesthetic Injection Via Peri-arterial Perineural Catheter Reverses Tourniquet Associated Ischemic Hypertension
A Phase 4 study testing Mepivacaine, Saline and Perifemoral Injection of Local Anesthetic in people with Tourniquet Hypertension and Intraoperative Hypertension, run by Duke University at 1 site in United States.
Trial summary
The goal of this prospective randomized double-blind study is to determine if an ultrasound guided peri-arterial injection of local anesthetic (LA) superomedially the femoral artery via peripheral nerve catheter reverses ischemic hypertension associated with prolonged lower extremity tourniquet time. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Tourniquet Hypertension, Intraoperative Hypertension, Total Ankle Arthroplasty
- What is being tested?
- Mepivacaine, Saline and Perifemoral Injection of Local Anesthetic
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2021to 3 Feb 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients that will be included in the study are English speaking 18-75 year old ASA 1-3 patients undergoing total ankle arthroplasty.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University Hospital
Durham, North Carolina, 27710
William M Bullock, MD, PhD, 919-681-6437, william.bullock@duke.edu
Amanda Kumar, MD, 919-681-6437, amanda.kumar@duke.edu
About this study
The goal of this prospective randomized double-blind study is to determine if an ultrasound guided peri-arterial injection of local anesthetic (LA) superomedially the femoral artery via peripheral nerve catheter reverses ischemic hypertension associated with prolonged lower extremity tourniquet time.
Read the detailed description
This is a research study to find out if injection of numbing medication by the large artery going down your leg will improve high blood pressure caused by the tourniquet.
Depending on whether you enroll in this study, you may receive an injection of local anesthetic (numbing medication) or saline (salt water) by your femoral artery (the large artery going down your leg). This is to see how this injection impacts your blood pressure during surgery as the surgeons use a tourniquet (device that squeezes your leg) to help decrease the bleeding during surgery. Oftentimes the tourniquet causes your blood pressure to go up, but the numbing medication may help return your blood pressure close to its normal level. The rest of your anesthesia care, including other nerve blocks and general anesthetic, will be the same as it would be without participating in the study. You will be enrolled in this study for 24 hours.
- Conditions
- Tourniquet Hypertension, Intraoperative Hypertension, Total Ankle Arthroplasty, Ankle Fusion
- Being tested
- Mepivacaine, Saline, Perifemoral Injection of Local Anesthetic
- Keywords
- Perifemoral, Tourniquet, Mepivacaine, Tourniquet Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MepivacaineDrug
Also called Carbocaine
An infiltration of mepivacaine superomedially to the femoral artery via perineural catheter.
SalineDrug
Also called Salt water placebo
An infiltration of saline superomedially to the femoral artery via perineural catheter.
Perifemoral Injection of Local AnestheticProcedure or surgery
Also called Femoral Periarterial Injection
Infiltration of mepivacaine superomedially to the formal artery via perineural catheter in an effort to numb the nerves that contribute to tourniquet hypertension intraoperatively.
Perifemoral Injection of Local AnestheticProcedure or surgery
Also called Femoral Periarterial Injection
Infiltration of saline superomedially to the formal artery via perineural catheter that should NOT numb the nerves that contribute to tourniquet hypertension intraoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Mepivacaine Block Group | Experimental | Infiltration of local anesthetic (mepivacaine) above and beside the femoral artery through a perineural catheter. Receives: Drug: Mepivacaine; Procedure: Perifemoral Injection of Local Anesthetic |
| Saline Sham Group | Placebo comparator | Infiltration of salt water (saline) above and beside the femoral artery through a perineural catheter. Receives: Drug: Saline; Procedure: Perifemoral Injection of Local Anesthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in tourniquet hypertension as measured by systolic blood pressure
Infiltrating study drug to reverse intraoperative tourniquet hypertension
Measured: From time of injection to 30 minutes after injection
Secondary outcomes (3)
Pain Scores (NRS11)
The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Measured: Perioperative start until 2 hours after admission to PACU
Opioid consumption
Perioperative opioid consumption as measured in oral morphine equivalents (OMEs)
Measured: Perioperative start until 2 hours after admission to PACU
Quadriceps motor function
Gross quadriceps motor function as measured by leg extension
Measured: 1 hour after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start5 Feb 2021
- Primary completion1 Feb 2027 (estimated)
- Study completion3 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourniquet HypertensionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amanda Kumar, MD, PhD, Principal investigator, Duke UniversityWilliam M Bullock, MD, PhD, Study director, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04454203
- Sponsor's protocol ID
- Pro00104144
- Status last verified
- Mar 2026
- First submitted
- 29 Jun 2020
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared; patients will be deidentified and no personal information or medical records used.