Local Anesthetic Injection for High Blood Pressure

Recruiting in Palo Alto (17 mi)

Overseen by Amanda Kumar, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Duke University

Must not be taking: Opioids

Disqualifiers: Chronic pain, Addiction, Psychiatric disorders, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are using opioids daily or have certain health conditions, you may not be eligible to participate.

What data supports the effectiveness of the drug Mepivacaine for high blood pressure?

Research shows that Mepivacaine, a local anesthetic, is effective in pain control and can cause local vasodilation (widening of blood vessels), which might indirectly suggest potential benefits for managing high blood pressure. ^{1 2 3 4 5}

Is the local anesthetic Mepivacaine safe for use in humans?

Research shows that Mepivacaine, used as a local anesthetic, is generally safe in humans. Studies on healthy volunteers and patients with high blood pressure have demonstrated its safety and effectiveness for local anesthesia. ^{5 6 7 8 9}

How is the drug Mepivacaine, used in perifemoral injection, different from other high blood pressure treatments?

This treatment is unique because it involves injecting a local anesthetic (a numbing medicine) directly around the femoral artery, which is not a common approach for treating high blood pressure. Most high blood pressure treatments involve oral medications that work throughout the body, rather than targeting a specific area with a local anesthetic. ^{1 4 10 11 12}

Research Team

Amanda Kumar, MD, PhD

Principal Investigator

Duke University

William M Bullock, MD, PhD

Principal Investigator

Duke University

Eligibility Criteria

This trial is for English-speaking adults aged 18-75 with good overall health (ASA 1-3) who are getting a total ankle replacement. It's not for pregnant women, those over 75 or under 18, people allergic to local anesthetics, underweight individuals (<50 kg), or anyone with conditions that could complicate surgery.

Inclusion Criteria

I am between 18-75 years old, speak English, and am having ankle surgery.

Exclusion Criteria

I cannot communicate my pain levels or need for pain relief.

You have an allergy or cannot tolerate local anesthetics.

I am either younger than 18 or older than 75.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive an injection of local anesthetic or saline by the femoral artery to assess impact on blood pressure during surgery

24 hours

1 visit (in-person)

Follow-up

Participants are monitored for changes in blood pressure, pain scores, opioid consumption, and quadriceps motor function

2 hours after admission to PACU

Treatment Details

Interventions

• Mepivacaine (Local Anesthetic)
• Perifemoral Injection of Local Anesthetic (Procedure)

Trial Overview The study tests if injecting a local anesthetic near the femoral artery can reverse high blood pressure caused by a tourniquet during ankle surgery. Participants will be randomly chosen to receive either saline or mepivacaine through a catheter and won't know which one they get.

Participant Groups

Group I: Mepivacaine Block Group Experimental Treatment 2 Interventions

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

Group II: Saline Sham Group Placebo Group 2 Interventions

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

Mepivacaine is already approved in Canada for the following indications:

Approved in Canada as Mepivacaine for:

• Local anesthesia for surgical procedures
• Dental anesthesia

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Mary E. Klotman

Duke University

Chief Executive Officer since 2017

MD from Duke University School of Medicine

Michelle McMurry-Heath

Duke University

Chief Medical Officer since 2020

MD from Duke University School of Medicine

Findings from Research

Four patients mistakenly injected with 1:1000 adrenaline instead of local anesthetic experienced severe cardiovascular symptoms, including elevated Troponin T and CPK levels, indicating heart stress or damage.

Over a five-year follow-up, all patients reported long-term effects such as tremor, muscle weakness, and shortness of breath, highlighting potential serious complications from this medical error that are not commonly documented in existing literature.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adrenaline toxicity following accidental administration of the 1:1000 solution during dental procedures: Four case reports. Fernando, DM., Dayaratne, KM.[2013]

In a study of 42 patients undergoing total hip arthroplasty (THA), adding a pre-incision intra-articular injection of local anesthetic did not show any significant benefits over the standard post-incision peri-articular injection alone in terms of postoperative outcomes.

The study suggests that while ultrasound-guided injections are a cost-effective method for administering local anesthetics, the combination of pre- and post-incision injections does not improve pain management or recovery metrics compared to the standard approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain After Preoperative Ultrasound Guided Hip Injections for Total Hip Arthroplasty: A Pilot Randomized Controlled Trial. Holbert, SE., Fowler, B., West, M., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Surgical-Site, Multimodal Drug Injection Following Operative Management of Femoral Fractures: A Randomized Controlled Trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Anesthetic efficacy and heart rate effects of the supplemental intraosseous injection of 2% mepivacaine with 1:20,000 levonordefrin. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Articaine (4%) with epinephrine (1:100,000 or 1:200,000) in intraosseous injections in symptomatic irreversible pulpitis of mandibular molars: anesthetic efficacy and cardiovascular effects. [2022]

4. China pubmed.ncbi.nlm.nih.gov

Efficacy of multimodal cocktail periarticular injection with or without steroid in total knee arthroplasty. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Study of the sympathetic effects of polocaine in a regional hallux block. [2013]

6. Spain pubmed.ncbi.nlm.nih.gov

Cardiovascular effect of dental anesthesia with articaine (40 mg with epinefrine 0,5 mg % and 40 mg with epinefrine 1 mg%) versus mepivacaine (30 mg and 20 mg with epinefrine 1 mg%) in medically compromised cardiac patients: a cross-over, randomized, single blinded study. [2021]

7. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Out-patient dental care in patients with arterial hypertension]. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Adrenaline toxicity following accidental administration of the 1:1000 solution during dental procedures: Four case reports. [2013]

9. China pubmed.ncbi.nlm.nih.gov

[Efficacy and safety of 3% mepivacaine hydrochloride injection for oral local anesthesia]. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Periarticular Liposomal Bupivacaine Injection Versus Intra-Articular Bupivacaine Infusion Catheter for Analgesia After Total Knee Arthroplasty: A Double-Blinded, Randomized Controlled Trial. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Periarticular Injections in Knee and Hip Arthroplasty: Where and What to Inject. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Pain After Preoperative Ultrasound Guided Hip Injections for Total Hip Arthroplasty: A Pilot Randomized Controlled Trial. [2023]