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NCT Number: NCT07644923

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

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Bupivacaine

Drug

5 ml of 0.25% bupivacaine

Lidocaine

Drug

5 ml of 1% lidocaine

Thrombin

Drug

10000 units of thrombin

Tranexamic Acid

Drug

500 mg of tranexamic acid

Aminocaproic acid

Drug

1000 mg of aminocaproic acid

Primary outcomes

  1. Pre-Operative Pain

    Time frame: Baseline (Day of Surgery)

    Pain rated on a scale from 0 (no pain) to 10 (highest level of pain ever experienced).

  2. Post-Operative Pain

    Time frame: Up to Day 14 Post-Operative

    Pain rated on a scale from 0 (no pain) to 10 (highest level of pain ever experienced).

Secondary outcomes

  1. Number of Opioid Prescription Pills Used

    Time frame: Up to Day 14 Post-Operative

    Opioid prescriptions (Norco 5/325 mg) will be given to patients post operatively. Total number of pills taken up until post operative day 14 will be recorded by the patient.

Study contacts

Contact information is provided by the study sponsor or research team.

Tom Calahan

CONTACT

[email protected]

929-455-5826

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

A Randomized, Single-Blinded, Controlled Study Evaluating Postoperative Non-Opioid Pain Management Utilizing Local Anesthetics Coupled With Modulated Coagulation

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jun 12, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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