Overview

Lidocaine Subcutaneous Infusion for Control of Treprostinil Related Site Pain

Status:
Terminated
Trial end date:
2012-04-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Jewish General Hospital
Treatments:
Lidocaine
Treprostinil
Criteria
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)