Lidocaine Subcutaneous Infusion for Control of Treprostinil Related Site Pain

Jewish General Hospital

Status and phase: Terminated; Phase 4

Conditions: Pulmonary Arterial Hypertension

Treatments: Drug: Lidocaine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01433328

JGH-11-096

Details and patient eligibility

About

Treprostinil subcutaneous (under the skin) infusion is a very good medication for treating pulmonary arterial hypertension but infusion site pain may be very severe in some patients. The investigators plan to treat patients receiving treprostinil with a subcutaneous infusion of lidocaine (a local anesthestic) to treat the pain.

Enrollment: 4 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• PAH
• Treprostinil treatment for at least 3 months
• Severe infusion site pain

Exclusion criteria

• Pregnancy/breastfeeding
• Decompensated heart failure
• Chronic liver disease
• Abnormal electrolytes
• Heart block (2/3 degree), sino-atrial block, idioventricular rhythm
• Systolic systemic BP <90mmHg
• Bradycardia HR <55
• Adverse reaction to lidocaine or other amide local anesthestic
• Interacting medications (anti-arrhythmics, CYP1A2 inhibitors)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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4 participants in 2 patient groups, including a placebo group

Lidocaine

Experimental group

Treatment:

Drug: Lidocaine

Placebo

Placebo Comparator group

Description:

Remodulin only

Treatment:

Drug: Placebo