Not Yet RecruitingPhase 4

Postoperative Non-Opioid Pain Management Utilizing Local Anesthetics Coupled With Modulated Coagulation

United States40 participantsStarted 2026-08-01

Plain-language summary

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 can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18 or older * Any patient undergoing elective hand surgery Exclusion Criteria: * Any patient with a traumatic or infected open wound (only surgically created wounds will be included) * History of chronic pain * History of narcotic addiction * History of recreational drug dependency * History of psychiatric pathology * Allergy or hypersensitivity to local anesthetics, recombinant human thrombin or tranexamic acid * History of coagulopathy or active thromboembolic disease * Any patient receiving a supra/infraclavicular block for anesthesia * Pregnancy * Hypersensitivity to hamster proteins * History of seizures * Significant renal impairment (chronic kidney disease stage 3 or greater) * History of retinal vascular disease or history of unexplained visual symptoms * Active upper urinary tract bleeding * History of known hypercoagulable disorder, prior thromboembolic events, or active clotting disorders * History of severe hepatic dysfunction (active hepatitis or steatohepatitis, hepatic fibrosis considered cirrhosis)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pre-Operative Pain

Timeframe: Baseline (Day of Surgery)

Post-Operative Pain

Timeframe: Up to Day 14 Post-Operative

Trial details

NCT IDNCT07644923

SponsorNYU Langone Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-08-01

Contact for this trial

Tom Calahan

929-455-5826 Thomas.Calahan@nyulangone.org

View on ClinicalTrials.gov More Postoperative Pain trials