Postoperative Non-Opioid Pain Management Utilizing Local Anesthetics Coupled With Modulated Coagulation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bupivacaine, Lidocaine, Thrombin, Tranexamic acid.
- Who it may be relevant to
- Registry conditions: Postoperative Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized, Single-Blinded, Controlled Study Evaluating Postoperative Non-Opioid Pain Management Utilizing Local Anesthetics Coupled With Modulated Coagulation
Overview
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.
Interventions
- Drug Bupivacaine
5 ml of 0.25% bupivacaine - Drug Lidocaine
5 ml of 1% lidocaine - Drug Thrombin
10000 units of thrombin - Drug Tranexamic acid
500 mg of tranexamic acid - Drug Aminocaproic acid
1000 mg of aminocaproic acid
Primary outcome measures
- Pre-Operative Pain [Time frame: Baseline (Day of Surgery)]
- Post-Operative Pain [Time frame: Up to Day 14 Post-Operative]
Secondary outcome measures (1)
- Number of Opioid Prescription Pills Used [Time frame: Up to Day 14 Post-Operative]
Eligibility criteria
Inclusion criteria
- Age 18 or older
- Any patient undergoing elective hand surgery
Exclusion criteria
- 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
- History of severe hepatic dysfunction (active hepatitis or steatohepatitis, hepatic fibrosis considered cirrhosis)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- NYU Langone Health — New York
Identifiers
NCT: NCT07644923 · 24-01580