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

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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07644923

Enrollment

Registered

2026-06-12

Start date

2026-08-01

Completion date

2029-02-01

Last updated

2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Brief 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.

Interventions

DRUGBupivacaine

5 ml of 0.25% bupivacaine

DRUGLidocaine

5 ml of 1% lidocaine

DRUGThrombin

10000 units of thrombin

DRUGTranexamic acid

500 mg of tranexamic acid

DRUGAminocaproic acid

1000 mg of aminocaproic acid

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Pre-Operative Pain	Baseline (Day of Surgery)	Pain rated on a scale from 0 (no pain) to 10 (highest level of pain ever experienced).
Post-Operative Pain	Up to Day 14 Post-Operative	Pain rated on a scale from 0 (no pain) to 10 (highest level of pain ever experienced).

Secondary

Measure	Time frame	Description
Number of Opioid Prescription Pills Used	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.

Countries

United States

Contacts

CONTACTTom Calahan

Thomas.Calahan@nyulangone.org929-455-5826

PRINCIPAL_INVESTIGATORDavid Chiu, MD

NYU Langone Health

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026