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

NYU Langone Health

Status and phase: Terminated; Phase 4

Conditions: Opioid Pain Medication

Treatments: Drug: Recombinant Human Thrombin; Drug: Lidocaine Hydrochloride with Epinephrine; Drug: Aminocaproic acid; Drug: Tranexamic acid; Drug: Bupivacaine Hydrochloride with Epinephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT04814433

20-01420

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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46 participants in 4 patient groups

Topical lidocaine and bupivacaine alone

Experimental group

Description:

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

Treatment:

Drug: Bupivacaine Hydrochloride with Epinephrine

Drug: Lidocaine Hydrochloride with Epinephrine

Topical lidocaine and bupivacaine with thrombin

Experimental group

Description:

In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin

Treatment:

Drug: Bupivacaine Hydrochloride with Epinephrine

Drug: Lidocaine Hydrochloride with Epinephrine

Drug: Recombinant Human Thrombin

Topical lidocaine and bupivacaine with thrombin and tranexamic acid

Experimental group

Description:

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

Treatment:

Drug: Bupivacaine Hydrochloride with Epinephrine

Drug: Tranexamic acid

Drug: Lidocaine Hydrochloride with Epinephrine

Drug: Recombinant Human Thrombin

Topical lidocaine and bupivacaine with thrombin and aminocaproic acid

Experimental group

Description:

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

Treatment:

Drug: Bupivacaine Hydrochloride with Epinephrine

Drug: Tranexamic acid

Drug: Aminocaproic acid

Drug: Lidocaine Hydrochloride with Epinephrine

Drug: Recombinant Human Thrombin