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

ConditionPostoperative Pain
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorNYU Langone Health

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 or older

Any patient undergoing elective hand surgery

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

40 Participants
are divided into 4 treatment groups
Group A: Bupivacaine + lidocaineExperimental treatment 2 interventions
Group B: Bupivacaine + lidocaine + thrombinExperimental treatment 3 interventions
Group C: Bupivacaine + lidocaine + thrombin + tranexamic acidExperimental treatment 4 interventions
Group D: Bupivacaine + lidocaine + thrombin + aminocaproic acidExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Pre-Operative Pain

Pain rated on a scale from 0 (no pain) to 10 (highest level of pain ever experienced).

Time frame
Baseline (Day of Surgery)
2

Post-Operative Pain

Pain rated on a scale from 0 (no pain) to 10 (highest level of pain ever experienced).

Time frame
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.

Time frame
Up to Day 14 Post-Operative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NYU Langone Health

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: