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

NCT ID: NCT04814433

Last Updated: 2024-06-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-24
• Study Completion Date: 2023-07-10

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.

Conditions

Opioid Pain Medication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Topical lidocaine and bupivacaine alone

In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine

Group Type: EXPERIMENTAL

Lidocaine Hydrochloride with Epinephrine

Intervention Type: DRUG

Topical lidocaine product is FDA approved as an amide local anesthetic in any indication for relief of pain associated with superficial minor surgery and as an adjunct for local infiltration anesthesia. It is frequently used as a standard local anesthetic for surgical procedures.

Each mL contains lidocaine hydrochloride and epinephrine, with 0.5 mg sodium metabisulfite as an antioxidant and 0.2 mg citric acid as a stabilizer.

Total of 5 mLs per open surgical study arm involving lidocaine hydrochloride and epinephrine will be given

Bupivacaine Hydrochloride with Epinephrine

Intervention Type: DRUG

Topical bupivacaine is FDA approved as indicated for the production of local anesthesia for procedures by infiltration injection. It is frequently used as a standard local anesthetic for surgical procedures.

Each mL contains bupivacaine hydrochloride and 0.005 mg epinephrine, with 0.5 mg sodium metabisulfite as an antioxidant and 0.2 mg citric acid (anhydrous) as stabilizer.

Total of 5 mLs per open surgical study arm involving Bupivacaine Hydrochloride with Epinephrine will be given

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

Group Type: EXPERIMENTAL

Recombinant Human Thrombin

Intervention Type: DRUG

Topical thrombin is FDA approved as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is not sufficient.

Recombinant human thrombin is available as 5000-unit and 20,000-unit vials of sterile recombinant topical thrombin lyophilized powder for solution. When reconstituted as directed, the final solution contains 1000 units/mL.

For topical application, a total of 10000 units per open surgical study arm involving use of Thrombin will be given

Lidocaine Hydrochloride with Epinephrine

Intervention Type: DRUG

Topical lidocaine product is FDA approved as an amide local anesthetic in any indication for relief of pain associated with superficial minor surgery and as an adjunct for local infiltration anesthesia. It is frequently used as a standard local anesthetic for surgical procedures.

Each mL contains lidocaine hydrochloride and epinephrine, with 0.5 mg sodium metabisulfite as an antioxidant and 0.2 mg citric acid as a stabilizer.

Total of 5 mLs per open surgical study arm involving lidocaine hydrochloride and epinephrine will be given

Bupivacaine Hydrochloride with Epinephrine

Intervention Type: DRUG

Topical bupivacaine is FDA approved as indicated for the production of local anesthesia for procedures by infiltration injection. It is frequently used as a standard local anesthetic for surgical procedures.

Each mL contains bupivacaine hydrochloride and 0.005 mg epinephrine, with 0.5 mg sodium metabisulfite as an antioxidant and 0.2 mg citric acid (anhydrous) as stabilizer.

Total of 5 mLs per open surgical study arm involving Bupivacaine Hydrochloride with Epinephrine will be given

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

Group Type: EXPERIMENTAL

Tranexamic acid

Intervention Type: DRUG

FDA-approved usage for intravenous tranexamic acid (TXA) is for heavy menstrual bleeding and short-term prevention in patients with hemophilia.

Total dose of 500 mg (20 mL) total will be given.

Recombinant Human Thrombin

Intervention Type: DRUG

Topical thrombin is FDA approved as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is not sufficient.

Recombinant human thrombin is available as 5000-unit and 20,000-unit vials of sterile recombinant topical thrombin lyophilized powder for solution. When reconstituted as directed, the final solution contains 1000 units/mL.

For topical application, a total of 10000 units per open surgical study arm involving use of Thrombin will be given

Lidocaine Hydrochloride with Epinephrine

Intervention Type: DRUG

Topical lidocaine product is FDA approved as an amide local anesthetic in any indication for relief of pain associated with superficial minor surgery and as an adjunct for local infiltration anesthesia. It is frequently used as a standard local anesthetic for surgical procedures.

Each mL contains lidocaine hydrochloride and epinephrine, with 0.5 mg sodium metabisulfite as an antioxidant and 0.2 mg citric acid as a stabilizer.

Total of 5 mLs per open surgical study arm involving lidocaine hydrochloride and epinephrine will be given

Bupivacaine Hydrochloride with Epinephrine

Intervention Type: DRUG

Topical bupivacaine is FDA approved as indicated for the production of local anesthesia for procedures by infiltration injection. It is frequently used as a standard local anesthetic for surgical procedures.

Each mL contains bupivacaine hydrochloride and 0.005 mg epinephrine, with 0.5 mg sodium metabisulfite as an antioxidant and 0.2 mg citric acid (anhydrous) as stabilizer.

Total of 5 mLs per open surgical study arm involving Bupivacaine Hydrochloride with Epinephrine will be given

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

Group Type: EXPERIMENTAL

Tranexamic acid

Intervention Type: DRUG

FDA-approved usage for intravenous tranexamic acid (TXA) is for heavy menstrual bleeding and short-term prevention in patients with hemophilia.

Total dose of 500 mg (20 mL) total will be given.

Aminocaproic acid

Intervention Type: DRUG

FDA notes that aminocaproic acid is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. Aminocaproic acid inhibits both the action of plasminogen activators and to a lesser degree, plasmin activity. The fibrinolysis-inhibitory effects of aminocaproic acid appear to be exerted principally via inhibition of plasminogen activators and to a lesser degree through antiplasmin activity. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Total of 1000 mg total will be given.

Recombinant Human Thrombin

Intervention Type: DRUG

Topical thrombin is FDA approved as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is not sufficient.

Recombinant human thrombin is available as 5000-unit and 20,000-unit vials of sterile recombinant topical thrombin lyophilized powder for solution. When reconstituted as directed, the final solution contains 1000 units/mL.

For topical application, a total of 10000 units per open surgical study arm involving use of Thrombin will be given

Lidocaine Hydrochloride with Epinephrine

Intervention Type: DRUG

Topical lidocaine product is FDA approved as an amide local anesthetic in any indication for relief of pain associated with superficial minor surgery and as an adjunct for local infiltration anesthesia. It is frequently used as a standard local anesthetic for surgical procedures.

Each mL contains lidocaine hydrochloride and epinephrine, with 0.5 mg sodium metabisulfite as an antioxidant and 0.2 mg citric acid as a stabilizer.

Total of 5 mLs per open surgical study arm involving lidocaine hydrochloride and epinephrine will be given

Bupivacaine Hydrochloride with Epinephrine

Intervention Type: DRUG

Topical bupivacaine is FDA approved as indicated for the production of local anesthesia for procedures by infiltration injection. It is frequently used as a standard local anesthetic for surgical procedures.

Each mL contains bupivacaine hydrochloride and 0.005 mg epinephrine, with 0.5 mg sodium metabisulfite as an antioxidant and 0.2 mg citric acid (anhydrous) as stabilizer.

Total of 5 mLs per open surgical study arm involving Bupivacaine Hydrochloride with Epinephrine will be given

Interventions

Tranexamic acid

FDA-approved usage for intravenous tranexamic acid (TXA) is for heavy menstrual bleeding and short-term prevention in patients with hemophilia.

Total dose of 500 mg (20 mL) total will be given.

Intervention Type: DRUG

Aminocaproic acid

FDA notes that aminocaproic acid is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. Aminocaproic acid inhibits both the action of plasminogen activators and to a lesser degree, plasmin activity. The fibrinolysis-inhibitory effects of aminocaproic acid appear to be exerted principally via inhibition of plasminogen activators and to a lesser degree through antiplasmin activity. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Total of 1000 mg total will be given.

Intervention Type: DRUG

Recombinant Human Thrombin

Topical thrombin is FDA approved as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is not sufficient.

Recombinant human thrombin is available as 5000-unit and 20,000-unit vials of sterile recombinant topical thrombin lyophilized powder for solution. When reconstituted as directed, the final solution contains 1000 units/mL.

For topical application, a total of 10000 units per open surgical study arm involving use of Thrombin will be given

Intervention Type: DRUG

Lidocaine Hydrochloride with Epinephrine

Topical lidocaine product is FDA approved as an amide local anesthetic in any indication for relief of pain associated with superficial minor surgery and as an adjunct for local infiltration anesthesia. It is frequently used as a standard local anesthetic for surgical procedures.

Each mL contains lidocaine hydrochloride and epinephrine, with 0.5 mg sodium metabisulfite as an antioxidant and 0.2 mg citric acid as a stabilizer.

Total of 5 mLs per open surgical study arm involving lidocaine hydrochloride and epinephrine will be given

Intervention Type: DRUG

Bupivacaine Hydrochloride with Epinephrine

Topical bupivacaine is FDA approved as indicated for the production of local anesthesia for procedures by infiltration injection. It is frequently used as a standard local anesthetic for surgical procedures.

Each mL contains bupivacaine hydrochloride and 0.005 mg epinephrine, with 0.5 mg sodium metabisulfite as an antioxidant and 0.2 mg citric acid (anhydrous) as stabilizer.

Total of 5 mLs per open surgical study arm involving Bupivacaine Hydrochloride with Epinephrine will be given

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Chiu, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

20-01420

Identifier Type: -

Identifier Source: org_study_id