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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:
All are applied topically to surgical bed prior to closure of skin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine + lidocaine | Experimental | Surgical created wounds for any hand surgery will be treated with bupivacaine + lidocaine. |
|
| Bupivacaine + lidocaine + thrombin | Experimental | Surgical created wounds for any hand surgery will be treated with bupivacaine + lidocaine + thrombin. |
|
| Bupivacaine + lidocaine + thrombin + tranexamic acid | Experimental | Surgical created wounds for any hand surgery will be treated with bupivacaine + lidocaine + thrombin + tranexamic acid. |
|
| Bupivacaine + lidocaine + thrombin + aminocaproic acid | Experimental | Surgical created wounds for any hand surgery will be treated with bupivacaine + lidocaine + thrombin + aminocaproic acid. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | 5 ml of 0.25% bupivacaine |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tom Calahan | Contact | 929-455-5826 | Thomas.Calahan@nyulangone.org |
| 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 |
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.
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 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
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D008012 | Lidocaine |
| D013917 | Thrombin |
| D014148 | Tranexamic Acid |
| D015119 | Aminocaproic Acid |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| 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 |
|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
| D000083 | Acetanilides |
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001685 | Biological Factors |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D000614 | Aminocaproates |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D000596 | Amino Acids |