A Randomized, Single-Blinded, Placebo-Controlled Study Evaluating Postoperative Non-Opioid Pain Management Utilizing Local Anesthetics Coupled With Modulated Coagulation
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- NYU Langone Health
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Change in Postoperative Pain Control
Study Overview
Brief Summary
This study is a prospective randomized trial examining the effect of topically combined antifibrinolytics (Tranexamic acid) with local anesthetics in all electively created surgical wound beds in hand surgery to provide long term pain relief and decrease the use of postoperative narcotics.
Detailed Description
The aim of the study is to provide long term pain relief and decrease the use of postoperative narcotics. All treatments are applied topically to the surgical bed prior to closure of the skin. Each of the drugs used in this study are Food and Drug Administration (FDA) approved and routinely used for pain relief. However, the route of administration of the drugs and addition of tranexamic acid or aminocaproic acid is considered off-label (outside of the FDA-approved indications) and therefore investigational.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age 18 or older
- •Any patient undergoing elective hand surgery
Exclusion Criteria
- •Any patient with a traumatic 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 to local anesthetics, recombinant human thrombin or tranexamic acid
- •Any patient receiving a supra/infraclavicular block for anesthesia
Arms & Interventions
Topical lidocaine and bupivacaine alone
In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine
Intervention: Lidocaine Hydrochloride with Epinephrine (Drug)
Topical lidocaine and bupivacaine alone
In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine
Intervention: Bupivacaine Hydrochloride with Epinephrine (Drug)
Topical lidocaine and bupivacaine with thrombin
In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin
Intervention: Recombinant Human Thrombin (Drug)
Topical lidocaine and bupivacaine with thrombin
In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin
Intervention: Lidocaine Hydrochloride with Epinephrine (Drug)
Topical lidocaine and bupivacaine with thrombin
In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin
Intervention: Bupivacaine Hydrochloride with Epinephrine (Drug)
Topical lidocaine and bupivacaine with thrombin and tranexamic acid
In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin, and 500 mg of tranexamic acid
Intervention: Tranexamic acid (Drug)
Topical lidocaine and bupivacaine with thrombin and tranexamic acid
In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin, and 500 mg of tranexamic acid
Intervention: Recombinant Human Thrombin (Drug)
Topical lidocaine and bupivacaine with thrombin and tranexamic acid
In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin, and 500 mg of tranexamic acid
Intervention: Lidocaine Hydrochloride with Epinephrine (Drug)
Topical lidocaine and bupivacaine with thrombin and tranexamic acid
In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin, and 500 mg of tranexamic acid
Intervention: Bupivacaine Hydrochloride with Epinephrine (Drug)
Topical lidocaine and bupivacaine with thrombin and aminocaproic acid
In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin, and 1000 mg of aminocaproic acid
Intervention: Tranexamic acid (Drug)
Topical lidocaine and bupivacaine with thrombin and aminocaproic acid
In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin, and 1000 mg of aminocaproic acid
Intervention: Aminocaproic acid (Drug)
Topical lidocaine and bupivacaine with thrombin and aminocaproic acid
In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin, and 1000 mg of aminocaproic acid
Intervention: Recombinant Human Thrombin (Drug)
Topical lidocaine and bupivacaine with thrombin and aminocaproic acid
In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin, and 1000 mg of aminocaproic acid
Intervention: Lidocaine Hydrochloride with Epinephrine (Drug)
Topical lidocaine and bupivacaine with thrombin and aminocaproic acid
In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin, and 1000 mg of aminocaproic acid
Intervention: Bupivacaine Hydrochloride with Epinephrine (Drug)
Outcomes
Primary Outcomes
Change in Postoperative Pain Control
Time Frame: Day 1 preoperative , Day 14 postoperative
Measured by self-reported level of pain recorded in a daily pain diary made by the researchers from the day of the surgery until post-operative day 14. The levels of pain are scored in the following manner: 1-2 no pain, 3-4 mild pain, 5-6 moderate pain, 7-8 severe pain, 9-10 worst pain imaginable.
Secondary Outcomes
- Amount of Opioid Pain Medication Required Postoperatively(From Day 1 postoperative to Day 14 postoperative)
- Total Time in Post Anesthesia Care Unit (PACU)(From Day 1 postoperative until discharge from PACU (up to 1 day))