Phase 4
N=31
Femoral Peri-arterial Local Anesthetic Injection Decreases Tourniquet Associated Ischemic Hypertension
Tourniquet Hypertension · Intraoperative Hypertension · Total Ankle Arthroplasty · Ankle Fusion
Bottom Line
View on ClinicalTrials.gov: NCT03390426 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Number of Subjects Experiencing Tourniquet Hypertension — 5; 14 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Mepivacaine (Drug); Perifemoral Injection of Local Anesthetic (Procedure); Saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Experiencing Tourniquet Hypertension |
5; 14 | — |
| SECONDARY Pain Scores as Measured by the Numeric Rating Scale (NRS-11) |
1.80; 1.07 | — |
| SECONDARY Amount of Opioid Pain Medications Used by Patient |
10.48; 8.19 | — |
| SECONDARY Amount of Esmolol Used Intraoperatively |
8.00; 95.33 | <0.05 sig |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03390426). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.