Opioid Pain MedicationPhase 4NCT04814433
Evaluating Postoperative Non-Opioid Pain Management Utilizing Local Anesthetics Coupled With Modulated Coagulation
A Phase 4 study testing Tranexamic acid, Aminocaproic acid and Recombinant Human Thrombin in people with Opioid Pain Medication, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Pain Medication
- What is being tested?
- Tranexamic acid, Aminocaproic acid and Recombinant Human Thrombin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2021to 10 Jul 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Any patient undergoing elective hand surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Single-Blinded, Placebo-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 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.
Read the 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.
- Conditions
- Opioid Pain Medication
- Being tested
- Tranexamic acid, Aminocaproic acid, Recombinant Human Thrombin, Lidocaine Hydrochloride with Epinephrine, Bupivacaine Hydrochloride with Epinephrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
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.
Aminocaproic acidDrug
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 ThrombinDrug
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 EpinephrineDrug
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 EpinephrineDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: Tranexamic acid; Drug: Aminocaproic acid; Drug: Recombinant Human Thrombin; Drug: Lidocaine Hydrochloride with Epinephrine; Drug: Bupivacaine Hydrochloride with Epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 preoperative , Day 14 postoperative
Secondary outcomes (2)
Amount of Opioid Pain Medication Required Postoperatively
Measured by self-reported number of pain pills taken postoperatively until post-operative day 14.
Measured: From Day 1 postoperative to Day 14 postoperative
Total Time in Post Anesthesia Care Unit (PACU)
Measured: From Day 1 postoperative until discharge from PACU (up to 1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start24 Mar 2021
- Primary completion10 Jul 2023
- Study completion10 Jul 2023
Why it stopped: Both lack of enrollment as well as study staff turnover
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opioid Pain MedicationStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Chiu, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04814433
- Sponsor's protocol ID
- 20-01420
- Status last verified
- May 2024
- First submitted
- 22 Mar 2021
- Last updated
- 26 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-Blinded, Placebo-Controlled Study Evaluating Postoperative Non-Opioid Pain Management Utilizing Local Anesthetics Coupled With Modulated Coagulation
- ClinicalTrials.gov ID
- NCT04814433
- Acronym / sponsor ID
- 20-01420
- Conditions
- Opioid Pain Medication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Both lack of enrollment as well as study staff turnover
- Enrolment
- 46 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 24 Mar 2021 (actual)
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 10 Jul 2023 (actual)
- First posted
- 24 Mar 2021 (actual)
- Results
- Posted 26 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Topical lidocaine and bupivacaine alone | Experimental | Drug: Lidocaine Hydrochloride with Epinephrine, Drug: Bupivacaine Hydrochloride with EpinephrineIn 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 | Drug: Recombinant Human Thrombin, Drug: Lidocaine Hydrochloride with Epinephrine, Drug: Bupivacaine Hydrochloride with EpinephrineIn 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 | Drug: Tranexamic acid, Drug: Recombinant Human Thrombin, Drug: Lidocaine Hydrochloride with Epinephrine, Drug: Bupivacaine Hydrochloride with EpinephrineIn 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 | Drug: Tranexamic acid, Drug: Aminocaproic acid, Drug: Recombinant Human Thrombin, Drug: Lidocaine Hydrochloride with Epinephrine, Drug: Bupivacaine Hydrochloride with EpinephrineIn 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 or older
- Any patient undergoing elective hand surgery
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic acidFDA-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. | Drug | Topical lidocaine and bupivacaine with thrombin and aminocaproic acid, Topical lidocaine and bupivacaine with thrombin and tranexamic acid |
| Aminocaproic acidFDA 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. | Drug | Topical lidocaine and bupivacaine with thrombin and aminocaproic acid |
| Recombinant Human ThrombinTopical 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 | Drug | 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 EpinephrineTopical 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 | Drug | 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 EpinephrineTopical 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 | Drug | 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 |
Primary outcome
Change in Postoperative Pain Control
Time frame: 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.
2 secondary outcomes
Amount of Opioid Pain Medication Required Postoperatively
Time frame: From Day 1 postoperative to Day 14 postoperative
Total Time in Post Anesthesia Care Unit (PACU)
Time frame: From Day 1 postoperative until discharge from PACU (up to 1 day)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Chiu, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic acid, Aminocaproic acid and Recombinant Human Thrombin in people with Opioid Pain Medication, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Postoperative Pain Control (time frame: Day 1 preoperative , Day 14 postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.