Evaluating Postoperative Non-Opioid Pain Management Utilizing Local Anesthetics Coupled With Modulated Coagulation
- Conditions
- Opioid Pain Medication
- Interventions
- Registration Number
- NCT04814433
- Lead Sponsor
- NYU Langone Health
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 46
- Age 18 or older
- Any patient undergoing elective hand surgery
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Topical lidocaine and bupivacaine with thrombin Recombinant Human Thrombin In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin Topical lidocaine and bupivacaine with thrombin and tranexamic acid Recombinant Human Thrombin 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 Topical lidocaine and bupivacaine with thrombin and aminocaproic acid Bupivacaine Hydrochloride with Epinephrine 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 Topical lidocaine and bupivacaine with thrombin Bupivacaine Hydrochloride with Epinephrine In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin Topical lidocaine and bupivacaine with thrombin and tranexamic acid Bupivacaine Hydrochloride with Epinephrine 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 Topical lidocaine and bupivacaine alone Lidocaine Hydrochloride with Epinephrine In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine Topical lidocaine and bupivacaine with thrombin Lidocaine Hydrochloride with Epinephrine In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin Topical lidocaine and bupivacaine with thrombin and tranexamic acid Lidocaine Hydrochloride with Epinephrine 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 Topical lidocaine and bupivacaine with thrombin and aminocaproic acid Lidocaine Hydrochloride with Epinephrine 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 Topical lidocaine and bupivacaine alone Bupivacaine Hydrochloride with Epinephrine In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine Topical lidocaine and bupivacaine with thrombin and aminocaproic acid Recombinant Human Thrombin 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 Topical lidocaine and bupivacaine with thrombin and tranexamic acid 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 Topical lidocaine and bupivacaine with thrombin and aminocaproic acid 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 1000 mg of aminocaproic acid Topical lidocaine and bupivacaine with thrombin and aminocaproic acid 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
- Primary Outcome Measures
Name Time Method Change in Postoperative Pain Control 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 Outcome Measures
Name Time Method Amount of Opioid Pain Medication Required Postoperatively From Day 1 postoperative to Day 14 postoperative Measured by self-reported number of pain pills taken postoperatively until post-operative day 14.
Total Time in Post Anesthesia Care Unit (PACU) From Day 1 postoperative until discharge from PACU (up to 1 day)
Trial Locations
- Locations (1)
NYU Langone Health
🇺🇸New York, New York, United States