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

NCT04814433 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 20-01420
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective randomized trial examining the effect of topically combined antifibrinolytics (Tranexamic acid) with local anesthetics in all electively created surgical wound beds in hand surgery to provide long term pain relief and decrease the use of postoperative narcotics.

Conditions

Opioid Pain Medication

Outcome Measures

Primary Outcomes (1)

• Change in Postoperative Pain Control

  Measured by self-reported level of pain recorded in a daily pain diary made by the researchers from the day of the surgery until post-operative day 14. The levels of pain are scored in the following manner: 1-2 no pain, 3-4 mild pain, 5-6 moderate pain, 7-8 severe pain, 9-10 worst pain imaginable.

  Day 1 preoperative , Day 14 postoperative

Secondary Outcomes (2)

• Amount of Opioid Pain Medication Required Postoperatively

  From Day 1 postoperative to Day 14 postoperative

• Total Time in Post Anesthesia Care Unit (PACU)

  From Day 1 postoperative until discharge from PACU (up to 1 day)

Study Arms (4)

Topical lidocaine and bupivacaine alone

EXPERIMENTAL

In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine

Drug: Lidocaine Hydrochloride with Epinephrine; Drug: Bupivacaine Hydrochloride with Epinephrine

Topical lidocaine and bupivacaine with thrombin

EXPERIMENTAL

In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin

Drug: Recombinant Human Thrombin; Drug: Lidocaine Hydrochloride with Epinephrine; Drug: Bupivacaine Hydrochloride with Epinephrine

Topical lidocaine and bupivacaine with thrombin and tranexamic acid

EXPERIMENTAL

In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin, and 500 mg of tranexamic acid

Drug: Tranexamic acid; Drug: Recombinant Human Thrombin; Drug: Lidocaine Hydrochloride with Epinephrine; Drug: Bupivacaine Hydrochloride with Epinephrine

Topical lidocaine and bupivacaine with thrombin and aminocaproic acid

EXPERIMENTAL

In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin, and 1000 mg of aminocaproic acid

Drug: Tranexamic acid; Drug: Aminocaproic acid; Drug: Recombinant Human Thrombin; Drug: Lidocaine Hydrochloride with Epinephrine; Drug: Bupivacaine Hydrochloride with Epinephrine

Interventions

Tranexamic acid DRUG

FDA-approved usage for intravenous tranexamic acid (TXA) is for heavy menstrual bleeding and short-term prevention in patients with hemophilia. Total dose of 500 mg (20 mL) total will be given.

Topical lidocaine and bupivacaine with thrombin and aminocaproic acid; Topical lidocaine and bupivacaine with thrombin and tranexamic acid

Aminocaproic acid DRUG

FDA notes that aminocaproic acid is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. Aminocaproic acid inhibits both the action of plasminogen activators and to a lesser degree, plasmin activity. The fibrinolysis-inhibitory effects of aminocaproic acid appear to be exerted principally via inhibition of plasminogen activators and to a lesser degree through antiplasmin activity. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Total of 1000 mg total will be given.

Topical lidocaine and bupivacaine with thrombin and aminocaproic acid

Recombinant Human Thrombin DRUG

Topical thrombin is FDA approved as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is not sufficient. Recombinant human thrombin is available as 5000-unit and 20,000-unit vials of sterile recombinant topical thrombin lyophilized powder for solution. When reconstituted as directed, the final solution contains 1000 units/mL. For topical application, a total of 10000 units per open surgical study arm involving use of Thrombin will be given

Topical lidocaine and bupivacaine with thrombin; Topical lidocaine and bupivacaine with thrombin and aminocaproic acid; Topical lidocaine and bupivacaine with thrombin and tranexamic acid

Lidocaine Hydrochloride with Epinephrine DRUG

Topical lidocaine product is FDA approved as an amide local anesthetic in any indication for relief of pain associated with superficial minor surgery and as an adjunct for local infiltration anesthesia. It is frequently used as a standard local anesthetic for surgical procedures. Each mL contains lidocaine hydrochloride and epinephrine, with 0.5 mg sodium metabisulfite as an antioxidant and 0.2 mg citric acid as a stabilizer. Total of 5 mLs per open surgical study arm involving lidocaine hydrochloride and epinephrine will be given

Topical lidocaine and bupivacaine alone; Topical lidocaine and bupivacaine with thrombin; Topical lidocaine and bupivacaine with thrombin and aminocaproic acid; Topical lidocaine and bupivacaine with thrombin and tranexamic acid

Bupivacaine Hydrochloride with Epinephrine DRUG

Topical bupivacaine is FDA approved as indicated for the production of local anesthesia for procedures by infiltration injection. It is frequently used as a standard local anesthetic for surgical procedures. Each mL contains bupivacaine hydrochloride and 0.005 mg epinephrine, with 0.5 mg sodium metabisulfite as an antioxidant and 0.2 mg citric acid (anhydrous) as stabilizer. Total of 5 mLs per open surgical study arm involving Bupivacaine Hydrochloride with Epinephrine will be given

Topical lidocaine and bupivacaine alone; Topical lidocaine and bupivacaine with thrombin; Topical lidocaine and bupivacaine with thrombin and aminocaproic acid; Topical lidocaine and bupivacaine with thrombin and tranexamic acid

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Any patient undergoing elective hand surgery

You may not qualify if:

• Any patient with a traumatic 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 to local anesthetics, recombinant human thrombin or tranexamic acid
• Any patient receiving a supra/infraclavicular block for anesthesia

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Interventions

Tranexamic Acid; Aminocaproic Acid; recombinant human thrombin; Lidocaine; Epinephrine; Bupivacaine

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminocaproates; Caproates; Acids, Acyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Thomas Calahan
• Organization: NYU Langone Health

Thomas.Calahan@nyulangone.org

929-455-5826

Study Officials

• David Chiu, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 24, 2021
• Study Start: March 24, 2021
• Primary Completion: July 10, 2023
• Study Completion: July 10, 2023
• Last Updated: June 26, 2024
• Results First Posted: June 26, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• Access Criteria: The investigator who proposed to use the data. Upon reasonable request. Requests should be directed to Thomas.Calahan@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)