Postoperative PainPhase 4NCT07644923
Postoperative Non-Opioid Pain Management Utilizing Local Anesthetics Coupled With Modulated Coagulation
A Phase 4 study testing Bupivacaine, Lidocaine and Thrombin in people with Postoperative Pain, run by NYU Langone Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Bupivacaine, Lidocaine and Thrombin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2026to 1 Feb 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- 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 or infected 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 or hypersensitivity to local anesthetics, recombinant human thrombin or tranexamic acid
Show all 16Show fewer
- History of coagulopathy or active thromboembolic disease
- Any patient receiving a supra/infraclavicular block for anesthesia
- Pregnancy
- Hypersensitivity to hamster proteins
- History of seizures
- Significant renal impairment (chronic kidney disease stage 3 or greater)
- History of retinal vascular disease or history of unexplained visual symptoms
- Active upper urinary tract bleeding
- History of known hypercoagulable disorder, prior thromboembolic events, or active clotting disorders
- History of severe hepatic dysfunction (active hepatitis or steatohepatitis, hepatic fibrosis considered cirrhosis)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Single-Blinded, 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 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:
- Bupivacaine + lidocaine
- Bupivacaine + lidocaine + thrombin
- Bupivacaine + lidocaine + thrombin + tranexamic acid
- Bupivacaine + lidocaine + thrombin + aminocaproic acid
All are applied topically to surgical bed prior to closure of skin.
- Conditions
- Postoperative Pain
- Being tested
- Bupivacaine, Lidocaine, Thrombin, Tranexamic acid, Aminocaproic acid
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
5 ml of 0.25% bupivacaine
LidocaineDrug
5 ml of 1% lidocaine
ThrombinDrug
10000 units of thrombin
Tranexamic acidDrug
500 mg of tranexamic acid
Aminocaproic acidDrug
1000 mg of aminocaproic acid
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine + lidocaine | Experimental | Surgical created wounds for any hand surgery will be treated with bupivacaine + lidocaine. Receives: Drug: Bupivacaine; Drug: Lidocaine |
| Bupivacaine + lidocaine + thrombin | Experimental | Surgical created wounds for any hand surgery will be treated with bupivacaine + lidocaine + thrombin. Receives: Drug: Bupivacaine; Drug: Lidocaine; Drug: Thrombin |
| Bupivacaine + lidocaine + thrombin + tranexamic acid | Experimental | Surgical created wounds for any hand surgery will be treated with bupivacaine + lidocaine + thrombin + tranexamic acid. Receives: Drug: Bupivacaine; Drug: Lidocaine; Drug: Thrombin; Drug: Tranexamic acid |
| Bupivacaine + lidocaine + thrombin + aminocaproic acid | Experimental | Surgical created wounds for any hand surgery will be treated with bupivacaine + lidocaine + thrombin + aminocaproic acid. Receives: Drug: Bupivacaine; Drug: Lidocaine; Drug: Thrombin; Drug: Aminocaproic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-Operative Pain
Pain rated on a scale from 0 (no pain) to 10 (highest level of pain ever experienced).
Measured: Baseline (Day of Surgery)
Post-Operative Pain
Pain rated on a scale from 0 (no pain) to 10 (highest level of pain ever experienced).
Measured: Up to Day 14 Post-Operative
Secondary outcomes (1)
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.
Measured: Up to Day 14 Post-Operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
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
- NCT07644923
- Sponsor's protocol ID
- 24-01580
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-Blinded, Controlled Study Evaluating Postoperative Non-Opioid Pain Management Utilizing Local Anesthetics Coupled With Modulated Coagulation
- ClinicalTrials.gov ID
- NCT07644923
- Acronym / sponsor ID
- 24-01580
- Conditions
- Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
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 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:
- Bupivacaine + lidocaine
- Bupivacaine + lidocaine + thrombin
- Bupivacaine + lidocaine + thrombin + tranexamic acid
- Bupivacaine + lidocaine + thrombin + aminocaproic acid
All are applied topically to surgical bed prior to closure of skin.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine + lidocaine | Experimental | Drug: Bupivacaine, Drug: LidocaineSurgical created wounds for any hand surgery will be treated with bupivacaine + lidocaine. |
| Bupivacaine + lidocaine + thrombin | Experimental | Drug: Bupivacaine, Drug: Lidocaine, Drug: ThrombinSurgical created wounds for any hand surgery will be treated with bupivacaine + lidocaine + thrombin. |
| Bupivacaine + lidocaine + thrombin + tranexamic acid | Experimental | Drug: Bupivacaine, Drug: Lidocaine, Drug: Thrombin, Drug: Tranexamic acidSurgical created wounds for any hand surgery will be treated with bupivacaine + lidocaine + thrombin + tranexamic acid. |
| Bupivacaine + lidocaine + thrombin + aminocaproic acid | Experimental | Drug: Bupivacaine, Drug: Lidocaine, Drug: Thrombin, Drug: Aminocaproic acidSurgical created wounds for any hand surgery will be treated with bupivacaine + lidocaine + thrombin + aminocaproic acid. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 or older
- Any patient undergoing elective hand surgery
Key exclusion criteria (16 listed)
- Any patient with a traumatic or infected 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 |
|---|---|---|
| Bupivacaine5 ml of 0.25% bupivacaine | Drug | Bupivacaine + lidocaine, Bupivacaine + lidocaine + thrombin, Bupivacaine + lidocaine + thrombin + aminocaproic acid, Bupivacaine + lidocaine + thrombin + tranexamic acid |
| Lidocaine5 ml of 1% lidocaine | Drug | Bupivacaine + lidocaine, Bupivacaine + lidocaine + thrombin, Bupivacaine + lidocaine + thrombin + aminocaproic acid, Bupivacaine + lidocaine + thrombin + tranexamic acid |
| Thrombin10000 units of thrombin | Drug | Bupivacaine + lidocaine + thrombin, Bupivacaine + lidocaine + thrombin + aminocaproic acid, Bupivacaine + lidocaine + thrombin + tranexamic acid |
| Tranexamic acid500 mg of tranexamic acid | Drug | Bupivacaine + lidocaine + thrombin + tranexamic acid |
| Aminocaproic acid1000 mg of aminocaproic acid | Drug | Bupivacaine + lidocaine + thrombin + aminocaproic acid |
Primary outcome
Pre-Operative Pain
Time frame: Baseline (Day of Surgery)
Pain rated on a scale from 0 (no pain) to 10 (highest level of pain ever experienced).
Post-Operative Pain
Time frame: Up to Day 14 Post-Operative
Pain rated on a scale from 0 (no pain) to 10 (highest level of pain ever experienced).
1 secondary outcome
Number of Opioid Prescription Pills Used
Time frame: Up to Day 14 Post-Operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: Yes. 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.
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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.
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 Bupivacaine, Lidocaine and Thrombin in people with Postoperative Pain, 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 16 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: opening soon, as of the sponsor's last update on 12 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tom Calahan (929-455-5826, Thomas.Calahan@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-Operative Pain (time frame: Baseline (Day of Surgery)). The study lists 2 primary outcomes in all. 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 12 Jun 2026.