Postoperative Non-Opioid Pain Management Utilizing Local Anesthetics Coupled With Modulated Coagulation
A Randomized, Single-Blinded, Controlled Study Evaluating Postoperative Non-Opioid Pain Management Utilizing Local Anesthetics Coupled With Modulated Coagulation
1 other identifier
interventional
40
1 country
1
Brief 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. All surgical created wounds for any hand surgery will be treated in a randomized fashion with the following four arms:
- 1.Bupivacaine + lidocaine
- 2.Bupivacaine + lidocaine + thrombin
- 3.Bupivacaine + lidocaine + thrombin + tranexamic acid
- 4.Bupivacaine + lidocaine + thrombin + aminocaproic acid
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 postoperative-pain
Started Aug 2026
Longer than P75 for phase_4 postoperative-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2026
CompletedFirst Posted
Study publicly available on registry
June 12, 2026
CompletedStudy Start
First participant enrolled
August 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2028
Study Completion
Last participant's last visit for all outcomes
February 1, 2029
June 12, 2026
June 1, 2026
2 years
June 9, 2026
June 9, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (1)
Number of Opioid Prescription Pills Used
Up to Day 14 Post-Operative
Study Arms (4)
Bupivacaine + lidocaine
EXPERIMENTALSurgical created wounds for any hand surgery will be treated with bupivacaine + lidocaine.
Bupivacaine + lidocaine + thrombin
EXPERIMENTALSurgical created wounds for any hand surgery will be treated with bupivacaine + lidocaine + thrombin.
Bupivacaine + lidocaine + thrombin + tranexamic acid
EXPERIMENTALSurgical created wounds for any hand surgery will be treated with bupivacaine + lidocaine + thrombin + tranexamic acid.
Bupivacaine + lidocaine + thrombin + aminocaproic acid
EXPERIMENTALSurgical created wounds for any hand surgery will be treated with bupivacaine + lidocaine + thrombin + aminocaproic acid.
Interventions
5 ml of 0.25% bupivacaine
5 ml of 1% lidocaine
10000 units of thrombin
1000 mg of aminocaproic acid
Eligibility Criteria
You may qualify if:
- Age 18 or older
- Any patient undergoing elective hand surgery
You may not qualify if:
- 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
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Chiu, MD
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2026
First Posted
June 12, 2026
Study Start (Estimated)
August 1, 2026
Primary Completion (Estimated)
August 1, 2028
Study Completion (Estimated)
February 1, 2029
Last Updated
June 12, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- 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
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.