Femoral Peri-arterial Local Anesthetic Injection Via Peri-arterial Perineural Catheter Reverses Tourniquet Associated Ischemic Hypertension

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT04454203
Phase
PHASE4
Status
Recruiting
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Conditions

  • Ankle Fusion
  • Intraoperative Hypertension
  • Total Ankle Arthroplasty
  • Tourniquet Hypertension

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Mepivacaine — DRUG
    An infiltration of mepivacaine superomedially to the femoral artery via perineural catheter.
  • Saline — DRUG
    An infiltration of saline superomedially to the femoral artery via perineural catheter.
  • Perifemoral Injection of Local Anesthetic — PROCEDURE
    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 — PROCEDURE
    Infiltration of saline superomedially to the formal artery via perineural catheter that should NOT numb the nerves that contribute to tourniquet hypertension intraoperatively.

Study Details

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.

Key Dates

Start date
Feb 5, 2021
Status verified
Mar 2026
Primary completion
Feb 1, 2027
Completion
Feb 3, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University HospitalDurhamNorth Carolina27710
William M Bullock, MD, PhD
[email protected]
919-681-6437
Amanda Kumar, MD
[email protected]
919-681-6437
Amanda Kumar, MD (PRINCIPAL_INVESTIGATOR)
William M Bullock, MD, PhD (SUB_INVESTIGATOR)
Jeff C Gadsden, MD (SUB_INVESTIGATOR)

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By research site
Duke University Hospital· Durham, NC

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