Postoperative Non-Opioid Pain Management Utilizing Local Anesthetics Coupled With Modulated Coagulation

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT07644923
Phase
PHASE4
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Postoperative Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bupivacaine — DRUG
    5 ml of 0.25% bupivacaine
  • 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

Study Details

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 All are applied topically to surgical bed prior to closure of skin.

Key Dates

Start date
Aug 1, 2026
Status verified
Jun 2026
Primary completion
Aug 1, 2028
Completion
Feb 1, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Bupivacaine + lidocaine
    Surgical created wounds for any hand surgery will be treated with bupivacaine + lidocaine.
  • Experimental: Bupivacaine + lidocaine + thrombin
    Surgical created wounds for any hand surgery will be treated with bupivacaine + lidocaine + thrombin.
  • Experimental: Bupivacaine + lidocaine + thrombin + tranexamic acid
    Surgical created wounds for any hand surgery will be treated with bupivacaine + lidocaine + thrombin + tranexamic acid.
  • Experimental: Bupivacaine + lidocaine + thrombin + aminocaproic acid
    Surgical created wounds for any hand surgery will be treated with bupivacaine + lidocaine + thrombin + aminocaproic acid.

Primary Outcome Measure

Pre-Operative Pain [ Time Frame: Baseline (Day of Surgery) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

Find similar trials in New York, NY

By research site
NYU Langone Health· New York, NY

Related Studies