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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Bupivacaine; Drug: Lidocaine; Drug: Thrombin; Drug: Tranexamic acid; Drug: Aminocaproic acid

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Tom Calahan; Phone Number: 929-455-5826; Email: Thomas.Calahan@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bupivacaine + lidocaine; Surgical created wounds for any hand surgery will be treated with bupivacaine + lidocaine.	Drug: Bupivacaine; 5 ml of 0.25% bupivacaine; Drug: Lidocaine; 5 ml of 1% lidocaine
Experimental: Bupivacaine + lidocaine + thrombin; Surgical created wounds for any hand surgery will be treated with bupivacaine + lidocaine + thrombin.	Drug: Bupivacaine; 5 ml of 0.25% bupivacaine; Drug: Lidocaine; 5 ml of 1% lidocaine; Drug: Thrombin; 10000 units of thrombin
Experimental: Bupivacaine + lidocaine + thrombin + tranexamic acid; Surgical created wounds for any hand surgery will be treated with bupivacaine + lidocaine + thrombin + tranexamic acid.	Drug: Bupivacaine; 5 ml of 0.25% bupivacaine; Drug: Lidocaine; 5 ml of 1% lidocaine; Drug: Thrombin; 10000 units of thrombin; Drug: Tranexamic acid; 500 mg of tranexamic acid
Experimental: Bupivacaine + lidocaine + thrombin + aminocaproic acid; Surgical created wounds for any hand surgery will be treated with bupivacaine + lidocaine + thrombin + aminocaproic acid.	Drug: Bupivacaine; 5 ml of 0.25% bupivacaine; Drug: Lidocaine; 5 ml of 1% lidocaine; Drug: Thrombin; 10000 units of thrombin; Drug: Aminocaproic acid; 1000 mg of aminocaproic acid

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Opioid Prescription Pills Used	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.	Up to Day 14 Post-Operative

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: David Chiu, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: June 9, 2026
• First Submitted That Met QC Criteria: June 9, 2026
• First Posted (Actual): June 12, 2026

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Biological Factors; Acids, Acyclic; Carboxylic Acids; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Hydrolases; Enzymes; Enzymes and Coenzymes; Blood Proteins; Amino Acids; Acids, Carbocyclic; Caproates; Endopeptidases; Peptide Hydrolases; Cyclohexanecarboxylic Acids; Serine Endopeptidases; Serine Proteases; Blood Coagulation Factors; Aminocaproates; Tranexamic Acid; Bupivacaine; Lidocaine; Aminocaproic Acid; Thrombin
• Other Study ID Numbers: 24-01580

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: [contact information for PI or designee]. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to dtwc@davidchiumd.com. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes