Lidocaine Subcutaneous Infusion for Control of Treprostinil Related Site Pain

Phase 4TerminatedNCT01433328

Jewish General Hospital4 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Pulmonary Arterial Hypertension

Interventions

LidocaineDRUG

Lidocaine

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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)

Locations (1)

Jewish General Hospital

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

Pain Questionnaire

Short Form McGill Pain Questionnaire - Change from baseline over one week

Time frame: 1 week

Daily Pain Diary

10cm visual analogue scale (VAS) - Change in aggregated median/maximum scores over one week

Time frame: 1 week

Secondary Outcomes

proNT-BNP

Time frame: 1 week

6 minute walk

Time frame: 1 week

Lidocaine level

Time frame: 1 week

Data from ClinicalTrials.gov

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