Recruiting

Local Anesthetic

Sponsor:

Duke University

Code:

NCT04454203

Conditions

Tourniquet Hypertension

Intraoperative Hypertension

Total Ankle Arthroplasty

Ankle Fusion

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Mepivacaine

Saline

Perifemoral Injection of Local Anesthetic

Perifemoral Injection of Local Anesthetic

Study Details

Brief 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.

Conditions

Tourniquet Hypertension

Intraoperative Hypertension

Total Ankle Arthroplasty

Ankle Fusion

Study ID

NCT04454203

Start date

Feb 5, 2021

Status verified date

Mar, 2026

Completion date

Feb 3, 2027

Anticipated

Primary completion date

Feb 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Mepivacaine Block Group

Infiltration of local anesthetic (mepivacaine) above and beside the femoral artery through a perineural catheter.

placebo comparator: Saline Sham Group

Infiltration of salt water (saline) above and beside the femoral artery through a perineural catheter.

Interventions

Mepivacaine

An infiltration of mepivacaine superomedially to the femoral artery via perineural catheter.

Saline

An infiltration of saline superomedially to the femoral artery via perineural catheter.

Perifemoral Injection of Local Anesthetic

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 Anesthetic

Infiltration of saline superomedially to the formal artery via perineural catheter that should NOT numb the nerves that contribute to tourniquet hypertension intraoperatively.

Primary outcome measure

  • Change in tourniquet hypertension as measured by systolic blood pressure [ Time Frame: From time of injection to 30 minutes after injection ]

Central Contacts and Locations

Central contacts

Locations

Duke University Hospital

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Principal Investigator:

Amanda Kumar, MD

More Information

Sponsor

Duke University

Last update posted

Mar 23, 2026

Last verified

Mar, 2026

Keywords

  • Perifemoral
  • Tourniquet
  • Mepivacaine
  • Tourniquet Hypertension

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-03-23.