Opioid Pain Medication
Conditions
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.
Detailed description
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.
Interventions
DRUGTranexamic acid
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.
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.
DRUGRecombinant Human Thrombin
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
DRUGLidocaine Hydrochloride with Epinephrine
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
DRUGBupivacaine Hydrochloride with Epinephrine
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
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18 or older * Any patient undergoing elective hand surgery
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Postoperative Pain Control | Day 1 preoperative , Day 14 postoperative | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Amount of Opioid Pain Medication Required Postoperatively | From Day 1 postoperative to Day 14 postoperative | Measured by self-reported number of pain pills taken postoperatively until post-operative day 14. |
| Total Time in Post Anesthesia Care Unit (PACU) | From Day 1 postoperative until discharge from PACU (up to 1 day) | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Topical Lidocaine and Bupivacaine Alone In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine | 8 |
| 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 | 6 |
| 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 | 5 |
| 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 | 6 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Survey not returned | 4 | 8 | 4 | 5 |
Baseline characteristics
| Characteristic | Topical Lidocaine and Bupivacaine Alone | Total | Topical Lidocaine and Bupivacaine With Thrombin and Aminocaproic Acid | Topical Lidocaine and Bupivacaine With Thrombin and Tranexamic Acid | Topical Lidocaine and Bupivacaine With Thrombin |
|---|---|---|---|---|---|
| Age, Continuous | 59 years STANDARD_DEVIATION 2.7 | 56 years STANDARD_DEVIATION 3.4 | 53 years STANDARD_DEVIATION 3.4 | 61 years STANDARD_DEVIATION 2.8 | 57 years STANDARD_DEVIATION 3.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 9 Participants | 2 Participants | 0 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 14 Participants | 4 Participants | 5 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 4 Participants | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 9 Participants | 2 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 10 Participants | 3 Participants | 3 Participants | 2 Participants |
| Region of Enrollment United States | 8 participants | 25 participants | 6 participants | 5 participants | 6 participants |
| Sex: Female, Male Female | 6 Participants | 19 Participants | 5 Participants | 4 Participants | 4 Participants |
| Sex: Female, Male Male | 2 Participants | 6 Participants | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 6 | 0 / 5 | 0 / 6 |
| other Total, other adverse events | 0 / 8 | 0 / 6 | 0 / 5 | 0 / 6 |
| serious Total, serious adverse events | 0 / 8 | 0 / 6 | 0 / 5 | 0 / 6 |
Outcome results
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.
Time frame: Day 1 preoperative , Day 14 postoperative
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Topical Lidocaine and Bupivacaine Alone | Change in Postoperative Pain Control | 4.8 units on a scale |
| Topical Lidocaine and Bupivacaine With Thrombin | Change in Postoperative Pain Control | 4.4 units on a scale |
| Topical Lidocaine and Bupivacaine With Thrombin and Tranexamic Acid | Change in Postoperative Pain Control | 5.1 units on a scale |
| Topical Lidocaine and Bupivacaine With Thrombin and Aminocaproic Acid | Change in Postoperative Pain Control | 4.7 units on a scale |
Secondary
Amount of Opioid Pain Medication Required Postoperatively
Measured by self-reported number of pain pills taken postoperatively until post-operative day 14.
Time frame: From Day 1 postoperative to Day 14 postoperative
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Topical Lidocaine and Bupivacaine Alone | Amount of Opioid Pain Medication Required Postoperatively | 5.5 Pills |
| Topical Lidocaine and Bupivacaine With Thrombin | Amount of Opioid Pain Medication Required Postoperatively | 5 Pills |
| Topical Lidocaine and Bupivacaine With Thrombin and Tranexamic Acid | Amount of Opioid Pain Medication Required Postoperatively | 5.7 Pills |
| Topical Lidocaine and Bupivacaine With Thrombin and Aminocaproic Acid | Amount of Opioid Pain Medication Required Postoperatively | 6 Pills |
Secondary
Total Time in Post Anesthesia Care Unit (PACU)
Time frame: From Day 1 postoperative until discharge from PACU (up to 1 day)
Population: 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.