Injection of numbing medication to reduce high blood pressure during ankle surgery
Femoral Peri-arterial Local Anesthetic Injection Via Peri-arterial Perineural Catheter Reverses Tourniquet Associated Ischemic Hypertension
This study tests if an injection of a numbing medication can help lower high blood pressure during ankle surgery caused by a tourniquet.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT04454203 on ClinicalTrials.gov |
What this trial studies
This prospective randomized double-blind study aims to evaluate the effectiveness of an ultrasound-guided peri-arterial injection of local anesthetic, specifically mepivacaine, in reversing ischemic hypertension caused by prolonged tourniquet use during total ankle arthroplasty. Participants will receive either the local anesthetic or saline injection near the femoral artery to assess its impact on blood pressure during surgery. The study will monitor patients for 24 hours post-injection to determine the efficacy of the treatment in managing tourniquet-associated hypertension.
Who should consider this trial
Good fit: Ideal candidates for this study are English-speaking adults aged 18-75 with ASA physical status classifications 1-3 undergoing total ankle arthroplasty.
Not a fit: Patients with ASA classifications 4 or 5, chronic pain conditions, or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve blood pressure management during surgeries that require tourniquets, enhancing patient safety and comfort.
How similar studies have performed: While the specific approach of this study may be novel, similar studies have shown promising results in managing tourniquet-associated hypertension with local anesthetics.
Eligibility criteria
Show full inclusion / exclusion 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: 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
Where this trial is running
Durham, North Carolina
- Duke University Hospital — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Amanda Kumar, MD, PhD — Duke University
- Study coordinator: William M Bullock, MD, PhD
- Email: william.bullock@duke.edu
- Phone: 919-681-6437
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.