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Both lack of enrollment as well as study staff turnover
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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.
The aim of the study is to provide long term pain relief and decrease the use of postoperative narcotics. All treatments are applied topically to the surgical bed prior to closure of the skin. Each of the drugs used in this study are Food and Drug Administration (FDA) approved and routinely used for pain relief. However, the route of administration of the drugs and addition of tranexamic acid or aminocaproic acid is considered off-label (outside of the FDA-approved indications) and therefore investigational.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of Opioid Pain Medication Required Postoperatively | Measured by self-reported number of pain pills taken postoperatively until post-operative day 14. | From Day 1 postoperative to Day 14 postoperative |
| Total Time in Post Anesthesia Care Unit (PACU) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Chiu, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Topical Lidocaine and Bupivacaine Alone | In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine |
| FG001 | Topical Lidocaine and Bupivacaine With Thrombin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 25, 2021 |
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| 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. |
|
| 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 |
|
| 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 |
|
| 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 |
|
| From Day 1 postoperative until discharge from PACU (up to 1 day) |
In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin
| FG002 | Topical Lidocaine and Bupivacaine With Thrombin and Tranexamic Acid | 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 |
| FG003 | Topical Lidocaine and Bupivacaine With Thrombin and Aminocaproic Acid | 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Topical Lidocaine and Bupivacaine Alone | In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine |
| BG001 | Topical Lidocaine and Bupivacaine With Thrombin | In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin |
| BG002 | Topical Lidocaine and Bupivacaine With Thrombin and Tranexamic Acid | 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 |
| BG003 | Topical Lidocaine and Bupivacaine With Thrombin and Aminocaproic Acid | 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 |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Full Range | units on a scale | Day 1 preoperative , Day 14 postoperative |
|
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| |||||||||||||||||||||||||||||||||||
| Secondary | Amount of Opioid Pain Medication Required Postoperatively | Measured by self-reported number of pain pills taken postoperatively until post-operative day 14. | Posted | Mean | Full Range | Pills | From Day 1 postoperative to Day 14 postoperative |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Total Time in Post Anesthesia Care Unit (PACU) | The outcome measure "total time in PACU" was not able to be assessed because there was no consistent measurement taken during the study by PACU nurses of this time period. | Posted | From Day 1 postoperative until discharge from PACU (up to 1 day) |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Topical Lidocaine and Bupivacaine Alone | In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine | 0 | 8 | 0 | 8 | 0 | 8 |
| EG001 | Topical Lidocaine and Bupivacaine With Thrombin | In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | Topical Lidocaine and Bupivacaine With Thrombin and Tranexamic Acid | 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 | 0 | 5 | 0 | 5 | 0 | 5 |
| EG003 | Topical Lidocaine and Bupivacaine With Thrombin and Aminocaproic Acid | 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 | 0 | 6 | 0 | 6 | 0 | 6 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Calahan | NYU Langone Health | 929-455-5826 | Thomas.Calahan@nyulangone.org |
| May 31, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D015119 | Aminocaproic Acid |
| C513462 | recombinant human thrombin |
| D008012 | Lidocaine |
| D004837 | Epinephrine |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000614 | Aminocaproates |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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