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Local Anesthetics + Coagulation Modulators for Postoperative Pain

TC
Overseen ByTom Calahan
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: NYU Langone Health
Disqualifiers: Chronic pain, Narcotic addiction, Psychiatric pathology, Coagulopathy, Renal impairment, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is a prospective randomized trial examining the effect of tranexamic acid (TXA) and aminocaproic acid (ε-Ahx) with local anesthetics and thrombin in all electively created surgical wound beds in hand surgery to provide long term pain relief and decrease the use of postoperative narcotics.

All surgical created wounds for any hand surgery will be treated in a randomized fashion with the following four arms:

1. Bupivacaine + lidocaine

2. Bupivacaine + lidocaine + thrombin

3. Bupivacaine + lidocaine + thrombin + tranexamic acid

4. Bupivacaine + lidocaine + thrombin + aminocaproic acid

All are applied topically to surgical bed prior to closure of skin.

Who Is on the Research Team?

DC

David Chiu, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for adults aged 18 or older who are having planned (elective) hand surgery. People with certain medical conditions may not be eligible, but the main requirement is being an adult scheduled for this type of surgery.

Inclusion Criteria

I am 18 years old or older.
I am scheduled for a planned hand surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo hand surgery with randomized application of local anesthetics and coagulation modifiers

Day of Surgery
1 visit (in-person)

Post-Operative Monitoring

Participants' pain levels and opioid use are monitored post-operatively

2 weeks
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Aminocaproic acid
  • Bupivacaine
  • Lidocaine
  • Thrombin
  • Tranexamic acid

Trial Overview

The study compares four different combinations of pain and bleeding control medicines applied directly to the surgical area during hand surgery. The goal is to see which combination best manages pain without using opioids after surgery.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Group I: Bupivacaine + lidocaine + thrombin + tranexamic acidExperimental Treatment4 Interventions
Group II: Bupivacaine + lidocaine + thrombin + aminocaproic acidExperimental Treatment4 Interventions
Group III: Bupivacaine + lidocaine + thrombinExperimental Treatment3 Interventions
Group IV: Bupivacaine + lidocaineExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

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